Implementation of a community-based breastfeeding support intervention to prolong duration of and reduce social inequality in exclusive breastfeeding: a mixed-methods systematic process evaluation in a cluster-randomised trial

Implementation of a community-based breastfeeding support intervention to prolong duration of and reduce social inequality in exclusive breastfeeding: a mixed-methods systematic process evaluation in a cluster-randomised trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Implementation of a community-based breastfeeding support intervention to prolong duration of and reduce social inequality in exclusive breastfeeding: a mixed-methods systematic process evaluation in a cluster-randomised trial Henriette Knold Rossau, Anne Kristine Gadeberg, Katrine Strandberg-Larsen, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3816186/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 08 Oct, 2024 Read the published version in International Journal for Equity in Health → Version 1 posted 9 You are reading this latest preprint version Abstract Background Breastfeeding is a powerful public health intervention that produce long-term health benefits. Still, in high-income countries such as Denmark, breastfeeding rates are suboptimal and distributed unequally across socio-economic positions. The ‘Breastfeeding – a good start together’ intervention to promote longer duration of and reduce social inequality in exclusive breastfeeding, was rolled out in a cluster-randomised trial during 2022–2023 in a sample of 21 municipalities in two Danish regions. A process evaluation was conducted to assess the fidelity and quality of the implementation and identify possible contextual factors that might have impacted the proposed mechanisms of change. Methods The Medical Research Counsel framework for conducting process evaluations guided the study, which was conducted using mixed-methods in a convergence design. Quantitative data: contextual mapping survey (n = 20), health visitor survey (n = 284), health visitor records from 20 clusters and intervention website statistics. Qualitative data: dialogue meetings (n = 7), focus groups (n = 3) and interviews (n = 8). Results Overall, the intervention was delivered as planned to intended recipients, with few exceptions. Health visitors reacted positively to the intervention, which they expressed fitted well within their usual practice and which they believed to enhance families’ chances for breastfeeding. Mothers expressed having received the intervention, with few exceptions, and reacted positively to the intervention. Health visitors worried about stigmatisation of the mothers receiving the intensified intervention, however none of the interviewed mothers had felt stigmatised. Contextual factors impacting the intervention implementation and mechanisms were staff- and management turnover, project infrastructure and mothers’ context, including resources, social network and previous experiences. Conclusions The overall fidelity of the intervention delivery was high. Health visitors and families responded well to the intervention. Interventions aimed at enabling health care providers to deliver simplified and structured breastfeeding support, in accordance with the support in other sectors of the health care system, may be a means to increase breastfeeding rates and reduce social inequality in breastfeeding, also in international contexts. Trial registration Clinical Trials: NCT05311631. First posted April 5, 2022. complex interventions process evaluation cluster-randomised trial implementation breastfeeding health visiting infant health socioeconomic factors delivery of health care public health Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 1 | Introduction On a global level, breastfeeding is a powerful public health intervention as it produces long-term health benefits and is a convenient, cost-effective and optimally nutritional food ( 1 , 2 ). In high-income countries, breastfeeding rates are suboptimal ( 3 ) and distributed unequally across socio-economic positions in favour of more advantaged groups ( 4 ). This also holds true in a Danish context ( 5 ). Mothers ask for available and individual support from health professionals ( 6 ) which has been underscored as crucial for duration and exclusivity of breastfeeding ( 7 ). Therefore, a breastfeeding support intervention: ‘Breastfeeding – a good start together’, was rolled out during 2022–2023 in a sample of 21 Danish municipalities ( 8 ) – henceforth referred to as ‘the Breastfeeding Trial’. In the Breastfeeding Trial, health visitors in the intervention arm (n = 11 clusters) received training to provide individualised breastfeeding support to new families, based on current evidence and theories such as self-efficacy, tailoring, and attributional retraining ( 9 ), and aligned with the breastfeeding support implemented at hospital level ( 10 ). The aim of the intervention was to strengthen breastfeeding support and increase the proportion of women accomplishing their breastfeeding duration goals. An additional hypothesis proposed that delivering a higher dose of the intervention through proactive telephone calls (termed: ‘intensified intervention’) to families with young mothers and/or low educational attainment could help reduce social inequality in breastfeeding. In a pre- and post-test study we have documented that the training programme enhanced health visitors' knowledge, action competence, and self-efficacy related to breastfeeding support ( 9 ). The present study is a mixed-methods systematic process evaluation of the Breastfeeding Trial prior to the trial effectiveness evaluation. Complex interventions like the Breastfeeding Trial are likely to reflect many causal assumptions. Identifying and stating these assumptions, or ‘programme theories’, is vital if process evaluation is to focus on the most important uncertainties that need to be addressed, and hence advance the understanding of the implementation and functioning of the intervention ( 11 ). The goal of a process evaluation is to illuminate the pathways linking what starts as an intervention and its hypothetical underlying causal assumptions to the outcomes produced in the end. Implementation in this article refers to the quality and fidelity of the delivered intervention. By exploring the intricacies of the implementation of the Breastfeeding Trial, this study will contribute to examine the interplay between intervention components, implementation strategies and intended outcomes, to facilitate a deeper understanding of how and why the intervention produces effects, drawing into account the facilitators and barriers to delivering the intervention. The findings from this study will inform future, planned evaluations of the trial ( 8 ), and essentially assist policymakers and practitioners in deciding on potential scale-ups of the intervention, but the study also hold the potential to inform implementations of other breastfeeding interventions or community-based interventions. 1.1 | Aim and objectives We aimed to assess the fidelity and quality of the implementation (dose, adaptations, reach) of the breastfeeding programme, and identify contextual factors in the health visitors’ work acting as barriers and facilitators in the mechanisms of change. We investigated this by addressing the specific research questions, informed by the programme theory (Fig. 1 ). The research questions were as follows: Was the intervention delivered as planned? To whom? What elements? What adaptations were made? What were the reactions and interactions with the intervention? Among health visitors Among families Were there any unintended effects related to the intervention? What contextual factors were important for the intervention to be implemented and delivered as planned? What impeded or facilitated the delivery of the intervention and the mechanisms of change? 2 | The Framework of the Intervention 2.1 | Setting In the present trial, the cluster units are municipalities. Municipalities are local areas of government with an array of responsibilities, including primary health care and prevention for children, under which the health visiting programme falls ( 12 ). In Denmark, all mothers and their newborn infants are discharged from hospital after birth to a follow-up programme delivered by health visitors employed in health visiting programmes of the municipalities. The health visiting programme mainly takes place in families’ homes, is a tax-based offer and is largely accepted by more than 97% of new families ( 13 ). Health visitors are registered nurses with an additional 18-month post-graduate education in promoting healthy families ( 14 ), including provisioning of breastfeeding support. In this setting, the present intervention was implemented. 2.2 | The intended intervention and implementation The intervention focussed on a strengthened breastfeeding support and included an 18 h skills training programme for health visitors encompassing breastfeeding physiology, breastfeeding support and tailoring of communication, among other things. Delivering a pregnancy visit to ensure parents’ breastfeeding preparation was part of the intervention. To support the intervention, materials were developed, including a dialogue sheet, a postcard, a pamphlet, and a website with guiding videos, podcasts and quizzes. Furthermore, the usual care four-month visit with guidance on how to introduce solid foods in the infant’s diet was to be postponed where possible to prolong exclusive breastfeeding. Thus, the ordinary four-month visit was replaced with a telephone call in which the individual parents’ needs regarding the introduction of solids were assessed. Health visitors in the intervention clusters were instructed to hand out the materials to new families and provide simple, evidence-based breastfeeding support (Fig. 1 ). The intervention has been described in detail elsewhere ( 8 ), as has the training programme ( 9 ). The four key messages in the intervention: 1) breastfeeding as a joint parenting task, 2) skin-to-skin contact, 3) proper breastfeeding positioning and 4) frequent breastfeeding, are evidence-based and have previously produced results in the ‘Less is More’ trial carried out in Danish maternity wards ( 15 , 16 ). It was subsequently politically decided to implement ‘Less is More’ throughout Danish maternity wards ( 10 ). The proactive telephone calls for mothers of young age or with low educational attainment, was inspired by an intervention study in which frequent telephone calls for mothers with pre-pregnancy BMI ≥ 30, who often have difficulties breastfeeding, were found to be effective for prolonging breastfeeding ( 17 ). Invitation to participate in the Breastfeeding Trial was addressed to managers of the health visiting programmes in the municipalities in the North Denmark Region and Region of Southern Denmark. In municipalities accepting participation, one or two local project representatives (depending upon numbers of newborns in the municipality) were appointed, with financial compensation from the project funds, to act as day-to-day project coordinators. Monthly dialogue meetings were held between intervention developers and local representatives from intervention clusters, during which issues regarding implementation and the intervention could be discussed. The dialogue meetings underpinned the implementation and were continually held from April 2022 until September 2023. 3 | Materials and Methods A mixed-methods design ( 18 ) was planned to comprehensively answer our research questions, and the Medical Research Counsel (MRC) framework for conducting process evaluations guided our assessment of the implementation ( 19 ). Process evaluations provide valuable insights into the ‘black box’ of contextual factors, delivery mechanisms, and fidelity of an intervention, uncovering critical factors that may influence intervention outcomes, and thus shed light on the intervention’s effectiveness and potential for scalability ( 19 ). Furthermore, they help to reveal unanticipated consequences and offer insights for the optimal integration of these interventions into existing practices ( 20 ). The CONSORT statement: extension to cluster randomised trials ( 21 ) and the Standards for Reporting Qualitative Research (SRQR) ( 22 ) guided the study reporting. 3.1 | Data sources The data sources are described in detail below, divided into whether collection was completed throughout all project clusters or in intervention clusters only. A full list of data sources and which research questions they inform is provided in Table 1 . 3.1.1 | Data collected in all clusters Organisational survey In early 2023, an organisational survey was distributed electronically to managers of the health visiting programmes in all municipalities. Because one intervention cluster dropped out immediately after the training programme, this cluster was omitted from the survey. The survey focused on the local and organisational context, and included the following themes: 1) management and size of the health visiting programme, 2) organisation of visits in the health visiting programme, prespecified according to the recommendations by the Danish National Board of Health, 3) estimation of the proportion in need of extra visits, and 4) organisation of staff, team meetings and conditions possibly impacting staff resources, and the managers were asked to reply based on their current programme. A full overview of the questions included in the questionnaire can be found in Additional File 1. Health visitor survey Electronic questionnaires were distributed to all health visitors employed in the participating municipalities: 1) at baseline: prior to training in December 2021, and 2) at follow-up: in October 2022 six months after training. Themes in the survey questionnaires were: 1) background and education, 2) breastfeeding support, attitudes, and practices in relation to breastfeeding support and self-reported relationships with families. Additionally, health visitors in the intervention arm were asked about their experience with the intervention, the training programme and the intervention material (for example experiences with and attitudes towards) at follow-up. Full overview of the questions included in the surveys, timepoints for distribution and recipients can be found in Additional File 2. Health visitor records Average visits and telephone calls per mother-infant dyad per month were collected from the health visitor records in each municipality. 3.1.2 | Additional data from clusters in the intervention arm only Website logins Use of the website was monitored by simple analytics providing number of logins with few options available for data extraction and no option for filtering data on municipality. Data accessible were most used unit of access (smart telephone vs. computer), average time spent during visits and most popular webpages on the website. Data from the intervention website was extracted of a one-year period from 1 June 2022 to 1 June 2023. Focus groups with health visitors Three semi-structured, online focus groups were conducted. Two health visitors from each of the municipalities in the intervention arm, not already appointed as local representative, were invited. Interviews with parents – predominately mothers Eight semi-structured interviews with mothers, one including both parents, and sampled from two of the intervention sites were conducted. Interviews were conducted either face to face in parents’ home (n = 5) or over the telephone (n = 3), depending on the interviewees’ preferences. Dialogue meetings Minutes and observations from the first seven of a total of 13 dialogue meetings informed the present process evaluation, during which a representative from the evaluation team participated in an observer role. ◊ Insert Table 1 3.3 | Analysis In the present study, the analysis was guided by the MRC Process Evaluation of Complex Interventions framework ( 19 ) and by the research questions specified above. 3.3.1 | Quantitative data Quantitative data were analysed descriptively and presented graphically. For comparisons of means, frequencies and medians across trial arms, Welch’s t -test, Chi-square, Fisher’s Exact test or one-way ANOVA on ranks test were used. Analyses were done using SAS statistical software ( 23 ). 3.3.2 | Qualitative data and analytical approach The individual interviews were conducted by HKR, who also moderated the focus groups, assisted by AKG as an observant. Qualitative data was analysed using Systematic Text Condensation (STC) focusing on participants’ expressed experiences ( 24 ). HKR, AKG and SFV discussed the transcripts and the initial coding. Coding was carried out using NVivo 14 software ( 25 ). 3.3.3 | Integration of findings Initial thorough analyses were conducted of each data source. Subsequently, using mixed-methods convergent design, integration of findings data sources was completed to compare findings’ convergence, divergence or complementarity and thereby gain an in-depth and comprehensive answer to the research questions ( 18 ). The aim was to provide a general impression of the fidelity to the intervention in the context in which it was implemented. 4 | Results 4.1 | Response rates and participants All managers of the project municipalities (n = 20) responded to the organisational survey, yielding a response rate of 100%. Data are provided in Table 2 . → Insert Table 2 The health visitor survey was distributed to 368 health visitors at baseline, and 351 health visitors at follow-up. Figure 2 presents a detailed flow diagram of the inclusion and attrition of participants in the survey waves. The response rates in the control arm and the intervention arm were 82% and 89% at baseline respectively, and 81% in both arms at follow-up, and 242 health visitors completed both baseline and follow-up, of which three changed trial-arm. The results are based on follow-up responses, except for Fig. 6 b in which self-reported assessment of breastfeeding support is based on the complete responses in the intervention arm. Data from health visitor records were obtained from all municipalities (n = 20). In dialogue meetings, all local representatives participated if possible (n = 13). In the seven meetings analysed, 12–13 local representatives participated in each. A coding tree of the analysis can be seen in Fig. 3 . Sixteen health visitors participated in the three focus groups, with four to seven participants in each. Four out of 10 municipalities participated with only one participant. Participants had between six months and 31 years of experience as a health visitor, two held an International Board Certified Lactation Consultant (IBCLC) degree, and one had not participated in the training programme (data not shown). A coding tree of the analysis of focus groups can be viewed in Fig. 4 . In the interviews with mothers, eight mothers and one father participated. Five mothers were eligible for intensified intervention, and four had accepted the offer. Mothers age ranged from 21–32, and the infants’ age at interview ranged from < 1–9 months (median 4 months). Four had either primary school or vocational education, one had secondary education and three had tertiary education as highest educational attainment. All participants were in a cohabitating relationship or married, three were primiparous and the rest multiparous. Five interviews were conducted face-to-face and three via telephone. A coding tree of the analysis of interviews can be found in Fig. 5 . 4.2 | Implementation – Was the intervention delivered as planned – to whom, what elements and were adaptations made? 4.2.1 | The training programme Of the 134 health visitors in the intervention arm responding at follow-up, 90% (n = 120) responded to have participated in full, while two (1%) had participated in parts of the breastfeeding support training programme (data not shown). Twelve (9%) had not participated at all. Reasons for not participating in the training were ‘ not employed at the time ’ (n = 7) and ‘ leave ’ (n = 5) (data not shown). Of the 12 non-participants, 11 reported having received one-to-one education from a colleague at the least. The remaining health visitor had not received any training (data not shown). Of the respondents in the intervention arm, 83% felt that the training had provided them the ability to deliver breastfeeding support in accordance with the intervention (Fig. 6 a). 4.2.2 | The breastfeeding support Most health visitors in the intervention arm reported that it had been their intention to guide and that they had in fact guided in accordance with the intervention, and that they furthermore intended to continue guiding in accordance with the intervention (Fig. 7 a), underlining the health visitors’ acceptance of the intervention. In the focus groups, health visitors expressed that the intervention breastfeeding support was aligned with their previous support, however simpler and therefore clearer. The four key messages, they expressed, helped them to structure the support and remember the most important things. “We really want to support breastfeeding, so we also thought it was valuable if we could do something to increase the breastfeeding rate. That’s what motivates us […]” (Health visitor 1) In Fig. 7 b, responses to questions regarding specific theory- and evidence-based elements that was part of the intervention is presented. Also here, most health visitors (90–98%) reported that they ‘ often ’ or ‘ almost always’ had delivered support in alignment with the intervention (Fig. 7 b). This was confirmed by qualitative data, where the health visitors described that they had tailored the information to fit parents’ needs, and that they had delivered the postcard, the check-the-milk pamphlet and the project website to all the families they encountered, furthermore confirmed by mothers participating in the interviews. “I think that the simpler it is with such a card (the postcard), the easier it is for them to comprehend. So even if you ask if we support the same way as usually? Yes, to some extent, but it is a good tool because we get to add something illustrative, and I think we lacked that before. And it helps underline the importance of it.” (Health visitor 2) The exception was the dialogue sheet. During the first dialogue meetings, local representatives had expressed that health visitors found it difficult to implement and use, especially if they had to use it after birth when there were many infant specific tasks to be completed during visits and little time. Therefore, the intervention developers and the local representatives had agreed to only use the dialogue sheet in pregnancy visits. Still, the delivery continued to be incomplete; just a couple of health visitors in focus groups expressed to have found the sheet useful, whereas the remaining participants believed that the sheet just duplicated the obtainment of families’ individual histories in the electronic record system usually done during pregnancy visits. Interview findings also confirmed this, as only two mothers had encountered the sheet. In municipalities that had not previously had pregnancy visits as part of their usual care, pregnancy visits had been in demand as expressed by local representatives in dialogue meetings and by health visitors in focus groups. This made them easy to implement. Health visitor records showed an increase in most intervention clusters (Table 3 ), thereby confirming the easy implementation. However, increases were also found in most control clusters (Table 3 ). → Insert Table 3 In interviews, a few mothers told of situations where the delivered breastfeeding support had acted against the intended intervention. For instance, a few mothers had been guided to try to space out feedings to counteract an infant’s rapid weight gain, and another had been told that it was normal to experience pain related to breastfeeding in the beginning. “When I asked my health visitor, she said that it was normal for breastfeeding to hurt in the beginning, because my body isn’t used to it and things like that. But that it at least should get better. It did when I was almost finished breastfeeding. But in the end, it ran out (the milk). […].” (Mother 3) 4.2.3 | The intensified intervention Another adaptation found across the qualitative data was the intensified intervention. During dialogue meetings, representatives expressed that health visitors in their teams wished to be able to adapt the delivery mode to include text messages in addition to the planned telephone calls, and that some had found it difficult to find a good way of voicing the reasons behind the offer of the intensified intervention to mothers in the target group without stigmatising them. Mothers confirmed the adaptation of the communication mode and expressed that they had received the planned intervention. Findings from the focus groups expanded these findings in that some health visitors found it easier than others to deliver the offer of the intensified intervention. Finding one’s own way of voicing the offer seemed to be key. Health visitors also talked about situations where they had refrained from offering the intensified intervention. In these situations, they had made a judgment call to prioritise other, more pressing circumstances than offering the intensified intervention, or they anticipated that a specific family would not have the resources to focus that much on breastfeeding. ”I think it depends on how well you ’sell it’ (the intensified intervention), and I think that some considers: ‘In this particular family, there is no point in even introducing it’. At least in our team, when we discussed it yesterday, some of my colleagues had no families in the intensified intervention, because they had reasoned: ‘They are not able to… It will be too much’. And so, the families may not even get the offer”. (Health visitor 1) Furthermore, health visitors expressed some frustration about the necessity of developing their own unique system to deliver the proactive calls in alignment with the plan and that they would sometimes adapt the scheduled contacts to fit their calendars, for example when a holiday would come up. Some would in such a case offer the contacts before or after the scheduled contact to avoid having colleagues take over, while others would leave it up to a colleague to handle. Health visitor records were highly ambiguous, however had a tendency towards convergence in that the mean number of telephone contacts increased in seven out of the 10 intervention clusters after the implementation of the intervention, whereas this was the case for less than half of the control clusters (Table 3 ). This also suggests that contamination regarding the intensified intervention across trial arms was unlikely. 4.2.4 | Postponing the introduction of solid food Implementation of the postponed four-month visit was reported by managers in the organisational survey to have been successful, although sometimes difficult to implement due to barriers related to families’ context to be elaborated below (data not shown). 4.3 | Mechanisms of impact – What were the reactions and interactions with the intervention – among health visitors, among families, and were there any adverse effects related to the intervention? 4.3.1 | The breastfeeding support Most health visitors (71%) with complete responses, felt that their breastfeeding support had improved since the implementation of the intervention, while some felt that their support had not changed (28%) or even worsened (1%) (Fig. 6 b). Health visitors largely believed the intervention was superior to usual breastfeeding support in establishing breastfeeding to ensure the infant’s thriving (76%, Fig. 8 a) and in strengthening parents’ belief that they could breastfeeding exclusively for four months (62%, Fig. 8 b), while 23% and 37%, respectively, found it equal to usual breastfeeding support. Regarding relationship formation with families and number of inquiries from families since the intervention commenced, health visitors largely reported the intervention to produce similar effects as the usual breastfeeding support (78% and 69%, respectively, Fig. 8 c-d). Confirming these findings, health visitors in focus groups expressed that the intervention fit well within their usual practice and that the training programme had enabled them to apply in-depth knowledge about for example mechanisms for milk production to their existing support. “ I feel that I had a lot of my knowledge confirmed during the training programme and gained some. I think it was good and I now provide the appropriate information depending on the family ’ s needs.” (Health visitor 8) Moreover, some health visitors expressed in focus groups to have focussed more on laid-back breastfeeding positioning and on the skin-to-skin approach when supporting families. All expressed satisfaction with the intervention materials, i.e., the postcard, Check-the-Milk pamphlet etc., which they considered appealing and felt had been missing, and further facilitated the provision of support via telephone. The postcard with the four key messages on the front and a website login on the back structured and simplified the breastfeeding support in that it helped health visitors remember to focus on the important things. Confirming this sentiment, in the survey, most health visitors reported that providing breastfeeding support in alignment with the intervention was simpler than before (46%) or the same as before (45%) (Fig. 9 ). Mothers in interviews were happy with the breastfeeding support they had received, except for the few accounts mentioned above, where the advice and support provided had been in discordance with the intervention. Still, in those cases the dissatisfaction seemed brief. Using the skin-to-skin approach to solve breastfeeding problems was advised in alignment with the intervention and had been successfully applied by a couple of mothers. 4.3.2 | Interactions with the intervention materials As described in the previous section about implementation, in the qualitative data, health visitors’ reactions to the dialogue sheet were mostly frustration. They generally felt micromanaged to do a task they believed they already covered. A few health visitors disconfirmed this by having found the sheet useful and to facilitate a deeper understanding for the families’ situations, in convergence with accounts from the few mothers who had encountered the sheet. Health visitors in the focus groups and dialogue meetings found the intervention website useful and expressed that sound, evidence-based knowledge about breastfeeding in Danish had been in demand. They were surprised that to their experiences, families seemed to not have utilized the website much. Website data showed that there had been more than 35,000 visits during a one-year period and confirmed that most logons (86%) had spent up to one minute (Fig. 10 ), which might cover health visitors’ introduction of the website to families, and the families’ independent logons to give the website a quick browse. However, further 11% of visitors spent between one to 10 minutes on the visit, while the remaining 3% spent 10–30 minutes or beyond (Fig. 10 ). Thus, even though website data confirmed most visits to be short, a considerable proportion, corresponding to more than 5,000 visits during a one-year period, lasted more than 10 minutes. This suggests that families with interests, utilised the website accordingly. This heterogenic use of the site was supported by interview data, as most mothers had taken a quick look, but also that some had spent a lot of time on it. The mothers generally expressed that the many videos on the website offered useful support in a timely manner. Viewing videos was expressed as easier than reading under the circumstances of having an infant on the arm, although some mothers with high educational attainment found other available material on the website useful, for example texts and podcasts. “Yeah, so if there was something we doubted, then he (the father) was the one reading about it and then passing on the information. So, he has used it (the website).” (Mother 6) Data from the website supported this inclination towards the videos with the ten most visited pages all being videos (Table 4 ). During dialogue meetings and in focus groups, health visitors were disappointed about the lack of a search option on the website and speculated that a smartphone application would have been used more, however, interview data offered no insights on the matter. Health visitors expressed a wish for continued use of the project website and postcard after the project finished, and interview data confirmed this, as mothers who had found good use of the intervention website deeply wished to have continued access and wanted everyone to gain access. → Insert Table 4 4.3.3 | The importance of preparation for breastfeeding In focus groups, health visitors expressed that a pregnancy visit was an important element in the intervention, providing an occasion to form a relationship with the families and to scope families’ wishes and intentions towards breastfeeding before the arrival of the infant after which challenges and emotions could lead to forgotten intentions. It provided a unique opportunity to tailor breastfeeding support by encouraging and guiding families based on their formerly expressed wishes and their current needs. “I find it important when we are on pregnancy visits to ask them when you hold the postcard: ‘What do you think? Do you feel like breastfeeding? Did you talk about it?’ […]. So that it is a choice and not something that I tell them to do. I think it is important, because then you have a chat about if they want to and how strongly they feel about it. […]. I think it is so important that you kind of balance it out: ‘What was it that we talked about back then, when they didn’t have those sore breasts and cracks and bleeding and were tired’” (Health visitor 1) Data from interviews confirmed this, and one mother explicitly expressed how the health visitor’s knowledge of the mother’s expressed wishes from before things got challenging, led to encouragement to try again at the right time, consequently facilitating continued breastfeeding that would have otherwise been discontinued. 4.3.4 | The intensified intervention The intensified intervention was believed to be time-consuming in both focus groups and dialogue meetings, although conversely, in a few exceptions, health visitors expressed that it preserved time. The health visitors found that the fixed structure of delivering the extra care in the intensified intervention needed development of a systematic approach for it to fit into their individual planning. Health visitors’ reactions to the intensified intervention covered a spectrum of ‘time-consuming waste of time’ to ‘it works really well’. In the former, it was believed that families who experienced needs would reach out themselves, thereby rendering the proactive approach superfluous. In the latter, health visitors had experienced being included in discussions of discontinuation of breastfeeding and believed to have been able to postpone the cessation due to the intensified intervention. They expressed that they were able to prevent discontinuation in multiparous families who ‘usually’ started bottle-feeding at certain time points. Furthermore, in families with concerns about sufficient milk supply due to the sudden emergence of more frequent feedings, they could articulate that infants increase the milk production according to their demand and that this probably was the reason for the changed feeding pattern. If nothing more, they said, they would have at least provided a pat on the back and a sense of security, and thus afforded parents an extra motivation to keep on breastfeeding. […] I have been contacted by parents in the intensified interventions: ‘We just want to ask you what you think – would it be okay to bottle-feed tonight?’. […] I have been able to prolong the breastfeeding by informing them: ‘Well, a lot is happening with your child emotionally and that’s why the baby wakes up and cries out for you more – it’s not just about the breastfeeding’. […] Or: ‘The baby eats faster now and gets more milk at a time, and that’s why the feedings are quicker now.’ (Health visitor 11) Data from interviewed mothers expanded focus group findings with information about how the frequent contacts from the health visitor made them feel that it would be no inconvenience if they themselves needed to contact the health visitor. Health visitors believed that the proactive telephone calls could potentially preserve time in cases where they would usually provide a needs-based visit ‘just in case’. In the future, they foresaw using the telephone calls to explore needs for a visit instead. They agreed that although the intensified intervention could be warranted in certain cases, the responsibility for identifying which should be up to the health visitors’ professional judgment. 4.3.5 | Postponing the introduction of solid food The postponement of the four-month visit was discussed in both dialogue meetings and focus groups. In dialogue meetings, the local representatives were worried that a postponement could result in inadvertent consequences by delaying the detection of inadequate motor-skills in infants. Expanding this, health visitors in focus groups expressed that in practice it could be difficult to postpone the visit, because families, especially multiparous-, expected a four-month visit, or because some families, especially primiparous-, were eager to begin introducing solids into the infant’s diet. The organisational survey offered the managers’ view of the uptake, which was overall positive, even with expressed wishes to keep the practice after the intervention ended, and health visitors in the focus group overall found the postponement meaningful. Interview data were silent on this matter. 4.3.6 | Possible adverse effects During dialogue meetings and in focus groups, concerns were raised about the risk of stigmatising mothers in the target group for intensified intervention by voicing the eligibility criteria. However, this was refuted, as the interviewed mothers did not express to have felt stigmatised. Some had not fully comprehended the motives for the offer. Confirming this, in a focus group one health visitor said that her manager had helped the team overcome the barrier for offering the intensified intervention by telling them to simply leave out reasons for the offer. Another concern raised in focus groups, was that the intensified intervention might inadvertently introduce insecurities in mothers if they interpreted telephone calls as a form of monitoring. Again, interview data disproved this, as mothers said that the close follow-up had stimulated a sense of security. ”Yeah, I thought it was super nice (receiving the proactive calls). I remember being a bit nervous about ‘oh no, will I be judged for being… you know… young’. But she was super nice, and it was quite comforting to know, like… Because she ensures me that she is only trying to help me. […] It felt very safe for me, I think […].” (Mother 2) 4.4 | Context – What contextual factors were important for the intervention to be implemented and delivered as planned – what impeded or facilitated the delivery of the intervention and the mechanisms of change? 4.4.1 | Organisational context In both trial arms there had been shifts in management and turnover of staff during the project period (Table 2 ). Despite statistical insignificant differences between groups, proportions were visually higher in the intervention arm with 50% of management and 18% of staff had been replaced since project start, compared to 30% and 12%, respectively. In focus groups, health visitors expressed the importance of management for the implementation, for instance by adapting project tasks such as recruitment to fit the context or by prioritising resources to the project. Participation in the training programme would instil a sense of ownership in the health visitors. Therefore, newly employed health visitors could end up impeding intervention implementation and delivery and some health visitors did indeed point out variation in colleagues’ attitude towards the intervention, they expressed. In the survey among health visitors, only a few had not participated in the training programme as mentioned above and responses suggested that most had felt some extent of managerial support in the intervention (Fig. 11 a), thereby disconfirming that lack of managerial support and sense of ownership might have threatened the intervention delivery. Moreover, health visitors largely reported that they had had time to familiarise themselves with the intervention and had read most of the intervention manual (Fig. 11 b-c), indicating that the organisations had allocated the resources necessary to implement the intervention. Two other organisational factors that affected the implementation were workload and financial resources. In focus groups, health visitors expressed how the workload of the intensified intervention would be distributed unequally within teams due to differences in the population composition in each health visitors’ assigned district. Data from the organisational survey showed that almost twice as many municipalities in the control arm had health visitors appointed especially to handle the care of a specific group, for instance young mothers or mothers of low educational attainment (control group: 70% vs. intervention group: 40%), despite the difference being statistically insignificant (Table 2 ). Financial cutbacks to the health visiting programme put pressure on available resources and on the individual health visitors, thereby impeding the implementation, as it was pointed out by focus group participants. 4.4.2 | The impact of local representatives Data from the survey among health visitors showed more frequent discussions with colleagues about breastfeeding in the intervention arm than in the control arm (Table 5 ), which adds information to the findings from the organisational survey, in which managers reported frequency of team meetings (Table 2 ). → Insert Table 5 In dialogue meetings, it became apparent that resourceful local representatives in team meetings and discussions would facilitate implementation and delivery of the intervention by facilitating adaptations to fit practice. Confirming this, health visitors in focus groups pointed to the same aspects being of importance and complemented by expressing that the local representative facilitated a maintained focus on the intervention and gave peptalks when it was needed, and furthermore how the direct link between local representatives and the intervention developers would facilitate a sense of ownership because questions could be raised and quickly answered, or adaptations made continuously. “ Well, I think that the occasional peptalk... And then also that the distance isn’t that long. We have experienced that something was changed, for example: ‘It just doesn’t make sense to call this mother – it feels stupid, because she just breastfeeds […]’. Like, she’ll (the local representative) then ask if it’s okay to just send a text message. And then that was okay. Yeah, then you kind of feel like we have influence.” (Health visitor 16) Contrary, when local representatives did not provide peptalks or put the intervention on team meeting agendas, the focus on the intervention faded out. 4.4.3 | The project infrastructure The intervention’s embeddedness in a large trial was frequently discussed during dialogue meetings, as the eligibility criteria for recruiting families to the trial in general and specifically to the intensified intervention placed a double burden on health visitors, because they also had to deliver the intervention. Focus group findings confirmed this but further expanded it informing that the project infrastructure ambiguously acted as a barrier for implementation due to the confusion and frustrations it posed, and as a facilitator because it ensured focus on the intervention and helped health visitors remember, for example, to deliver intervention materials to families. “[…] Because I think that some of my focus comes when I sit with the family and must present and tell them: ‘We have this breastfeeding project’, and then the postcard and the website are presented, and we talk about enrolling them and what it encompasses. Then we’re already caught up in talking about breastfeeding […]” (Health visitor 13) 4.4.4 | The influence of mothers’ context In focus groups health visitors expressed that the mothers’ context impacted the intervention. This was confirmed by mothers in interviews. For instance, family members could support or argue against the efforts involved in making breastfeeding work, or a partner could provide a due diligent push to facilitate successful breastfeeding. ”If he hadn’t pushed me to express my milk… Or not push, but support me, then I would have stopped entirely and gone with formula” (Mother 2) Similarly, members of ‘mother’s groups’ could support each other in breastfeeding, or conversely praise the advantages of infant formula and thereby end up creating a ripple effect. As expressed by a health visitor: “ I have also experienced the impact of the mothers’ group, specifically if they have talked about their experiences with bottle feeding […]. Then when I visit, they tell me: ‘We have started bottle feeding’, and I have not been involvement. I then ask: ‘Where did you get the inspiration from?', ‘We heard from the mothers' group that it was really good’. So, I think that the mothers' group also has an influence on what people choose. And it also differs what kind of mothers' group you are in. Is it a group where everyone breastfeeds? Or is it a mother's group where a large proportion bottle feed? So, it is at least something that I also think we are up against.” (Health visitor 7) Another contextual factor was parity. Parity could impede the postponement of the four-month visit, as mentioned above. Managers of intervention municipalities confirmed that the families’ context could impede the postponement. Mothers expanded multiparity to act as a facilitating factor for mechanisms in instances where previous experiences provided the right prerequisites to prepare for breastfeeding and seek out as much help as possible, for example from the hospitals’ antenatal care and during pregnancy visits. Conversely, repeated negative experiences with breastfeeding could cause a family to give up. Additionally, the health care context impacted the intervention. Mothers expressed that overall, the breastfeeding support provided in hospital was consistent with the support provided by the health visitors, however, they also told stories of situations in which the support counteracted the intervention, for example when health professionals handed out nipple shields to alleviate pain or instilled notions about the necessity of supplementing with formula until the milk had come in. ” […] We were at the hospital on day two (after birth), and then a couple of nurses came in, and then she (the infant) was fed some formula, because (they said) it can take a while for your milk to come in properly.” (Mother 1) A mother’s resources, e.g., psychosocial-, educational- and mental resources, would facilitate the intervention as it enabled her to set the intention about breastfeeding and thereby receive help from her partner, cope with challenges, seek out help from others when needed and critically appraise advice and support received. All in all, having resources enabled a mother to succeed in breastfeeding. However, the intervention was designed to enhance a mother’s self-efficacy, among other things by identifying people in the social surroundings able to support with good breastfeeding accounts and to build action competence to enable the overcoming of obstacles, by for example providing knowledge and evidence-based support. Thus, when mothers with less resources were unable to overcome challenges they faced, it may point to parts of the intervention not being delivered as intended. 5 | Discussion The aim of the present study was to assess the fidelity and quality of the implementation of the breastfeeding intervention and identify contextual factors in the health visitors’ work potentially leading to variation in outcomes. Investigating the processes of delivery and implementation of the intervention prior to analysing the effectiveness of it was important for the authors, to remain unbiased towards the processes ( 19 ). Overall, our findings show that the intervention fidelity was high with the intervention generally being delivered as planned to the intended recipients. Exceptions were the dialogue sheet, which was not delivered consistently, and the reach of the intensified intervention, which was not consistently offered to the target group. Health visitors’ reactions to and interactions with the intervention were positive. They expressed that the intervention fitted well into their usual practice, had provided a structure to, and simplified their usual breastfeeding support, and that they believed it to improve families’ chances for breastfeeding, thus facilitating the implementation. Furthermore, mothers expressed having received the intervention as planned and reacted positively to the intervention materials and to the intensified intervention. Contextual factors that might have impacted the implementation and delivery of the intervention was staff- and management turnover, the project infrastructure that entailed a dual task for health visitors in delivering the intervention and recruitment to the trial, and the mothers’ individual contexts that influenced the mechanisms of change. Various contextual factors existed across trial arms, suggesting that these organisational aspects may also apply beyond the participating municipalities to the wider national context of the Danish health visiting programmes. These factors play a role in the interpretation of the future effectiveness study and in deciding on potential scale-ups of the intervention. First, the content of the health visiting programmes across the trial arms was found to be largely similar, meaning that parents in the control arm may have received an offer very similar in structure to the intervention. However, due to the randomised nature of the study and to the statements made by health visitors in the intervention arm about how their breastfeeding support had become simpler and more structured, we argue that the quality of the offers received across trial arms will likely have been different. Moreover, a simpler breastfeeding support may more comprehensible across different levels of health literacy and thereby holds the potential to reduce social inequality. Pregnancy visits were offered in most municipalities in both trial arms, and a higher proportion of control clusters reported having specific health visitors appointed to handle care of special groups, e.g., the target group for the intensified intervention. This suggests that a scale-up of the intervention may be easily accomplished in the Danish context. Transferability to other settings will need to take into consideration the interaction and fit between the intervention and context. Second, relationship formation between mothers and health professionals, open communication about breastfeeding goals and continuity in the support provided, have been proved as facilitating delivery of tailored and effective breastfeeding support ( 26 , 27 ). This was confirmed by the mothers in this study. Qualitative studies of breastfeeding support for vulnerable groups have found that the social network is important in supporting lactating women, and how some women choose not to consult with a health professional despite having needs ( 6 , 28 ). Our results suggests that pregnancy visits help facilitate the intervention delivery by founding the relationship and preparing women for breastfeeding, and furthermore that the intensified intervention seemed to facilitate reaching out to health visitors. Contextual factors such as staff-turnover may have impacted on this continuity of care, however seemingly not to an extend where the intervention mechanisms were hindered. We assume that the intervention will produce effects because the pregnancy visits helped facilitate health visitors’ provision of tailored support, and we recommend that the impact of proper breastfeeding preparation in pregnancy should be explored in other contexts or maintained when already existing. Third, fathers/partners have been stressed as having major influence on the breastfeeding either by supporting or undermining breastfeeding ( 29 ). Our empirical data from interviews with mothers supports this and our analysis further expands it to be catalysed by the mother’s expressed intention for breastfeeding. This finding supports the intervention’s intention that breastfeeding support should be provided to both parents for mothers to express their intention and for partners to back this intention. Future analyses of the impact of inclusion of fathers/partners in the breastfeeding support is planned in the Breastfeeding Trial and will provide a deeper understanding of the intervention mechanisms. Fourth, health visitors in the intervention arm reported to have discussed breastfeeding with colleagues more frequently than health visitors in the control arm, and may have facilitated the implementation, although this was not mentioned by the health visitors participating in the focus groups. According to Chesnel et al. ( 30 ), the opportunity to discuss support practices with colleagues is an important part of breastfeeding education, but frequent discussions may, if the breastfeeding support is outdated, impede the entire teams’ provision of breastfeeding support. We recently established that the training programme was effective on health visitors’ self-reported self-efficacy and action competence and somewhat on knowledge ( 9 ). The health visitors in present study highlighted that having gained knowledge was one of the major benefits of the intervention. This suggests that the knowledge constructs investigated in the previous article, may have overlooked other important knowledge components. Still, some mothers had experienced support in opposition with the health visitors’ training, indicating that changing practice and unlearning routines is difficult, despite being taught otherwise, also previously implied by Dykes ( 31 ). Consequently, relevant revisions of the intervention should involve ensuring collegial discussions and training should include unlearning of inappropriate and potentially outdated practices. Both factors are most likely relevant across different contexts. Finally, contextual factors external to the health visiting programmes also influenced the implementation and mechanisms of the intervention. During the intervention period earmarked paternity leave was politically introduced in Denmark, leading to 11 weeks out of the 52 weeks legally dedicated parental leave for employees, being allocated to the father/partner ( 32 ). While we do not contest the political context for the legislative introduction of paternity leave, this may have antagonised the intervention by accelerating the introduction of solid food into the infants’ diet to be able to feed the infant while the mother is back at work, while the intervention sought to postpone this introduction of solid foods. In an international perspective, the Danish parental leave, although reformed, ensures good circumstances for family wellbeing ( 33 ) and is among the most privileged globally. If in future studies we find that the intervention effect is overshadowed by the parental leave reform, the intervention might have had even lower odds in countries with poorer leave legislation. Taking all these contextual aspects into consideration, we maintain that the present intervention holds the potential to improve breastfeeding rates and reduce social inequality in breastfeeding in a Danish context given the findings of this study and because it offers an approach that is highly acceptable by the health care providers and because families of lower health literacy levels may be more likely to comprehend four simple messages than an array of recommendations. Adaptation of the intervention to other contexts may require consideration of the contextual aspects found to impact the intervention mechanisms; however, simplifying breastfeeding support to focus on four simple messages based on evidence seems a low-hanging fruit with potential to implemented and tested in other settings. 5.1 | Strengths and limitations This process evaluation has many strengths, for instance, the variety of data sources, systematic coverage and analytical integration. Having collected data in the control clusters offers an insight into the contextual factors at play across the trial arms. Moreover, we chose to invite health visitors not already involved as local representatives to the focus groups, because we anticipated that the local representatives would be more positive about the project and breastfeeding in general than their colleagues. Nevertheless, selection bias was a risk but seemed to be low as health visitors in the focus groups expressed very different opinions towards the project. The study also holds several limitations. First, having collected data for the process evaluation prior to completing the data collection might enhance the focus on breastfeeding in the control clusters, leading to a possible contamination across trial arms. Second, the data themselves hold limitations, such as bias due to self-report, quality of data extracted from health visitor records, selection bias in both the health visitor survey and in the qualitative data collection, and in the conduct of focus groups online. The moderator’s role in online focus groups is generally perceived similar to regular focus groups, but advisably taking a more active role to maintain a steady flow of communication ( 34 ). The online focus groups in the present study bordered on structured group interviews. Yet, the trade-off was, that all participants voiced their opinions and therefore no participants ended up generating data alone. Third, due to the multitude of data sources the analysis could only scratch the surface of mechanisms. However, future planned studies using Realist Evaluation methods aim to explore specific mechanisms of change in the intervention in more depth ( 8 ). And finally, the process evaluation may lead to potentially strengthened breastfeeding support due to the enhanced focus on the intervention. Therefore, even if conducting more investigation of the support in the control arm would have further illuminated similarities and differences across trial arms, we chose to meddle as little as possible in the control arm to decrease the risk of contamination ( 35 ). 6 | Conclusion The overall fidelity of the intervention delivery was high. Health visitors found the intervention to fit well within their practice and that using it structured and simplified their breastfeeding support. Parents were positive about the support received and the intervention material and found the proactive telephone calls in the intensified intervention to provide a sense of security. Organisational factors such as staff and management turnover acted as a barrier for the implementation. The present study offers a lens through which to view the upcoming effectiveness evaluation. Interventions aimed at enabling health care providers to deliver simplified and structured breastfeeding support like the one studied in this article, may be a means to increase breastfeeding rates and reduce social inequality in breastfeeding also in other contexts, nationally and internationally, because it offers an approach that is highly acceptable by the health care providers and potentially easier to comprehend and apply for families of lower health literacy levels. Abbreviations BMI Body Mass Index IBCLC International Board Certified Lactation Consultant MRC Medical Research Counsil Declarations Ethics approval and consent to participate The study is conducted in accordance with the Declaration of Helsinki (36) and gained approval from the Research Ethics Committee at University of Copenhagen (Cno. 504-0276/21-5000). The study protocol is registered at Clinical Trials: NCT05311631 https://clinicaltrials.gov/ct2/show/NCT05311631. First posted April 5, 2022. Selection of mothers to the intensified intervention was based solely on two criteria: young age and/or low educational attainment. The decision was not based on a needs assessment of the individual mother and her chances of obtaining a successful breastfeeding trajectory by the health visitor. This may imply that mothers of young age and/or with low educational attainment may have felt wrongfully stigmatised and placed in the ‘high-risk’ category, despite our data disconfirming this. Conversely, the selection criteria may have caused mothers to be overlooked, who might have benefitted from the intensified intervention. Managers of the participating health visiting programmes signed a collaboration agreement, including consent to participate in data collection. Participation in the health visitor survey was voluntary, and health visitors gave their informed consent by participating. Informed content was collected verbally and in writing among all families and health visitors participating in interviews and focus group discussions, respectively. Consent for publication Not applicable Availability of data and materials Quantitative data from surveys will be available upon reasonable request. Because the qualitative data include sensitive information about informants, these data will not be available. Competing interests The authors declare that they have no conflicts of interest. Funding This study was funded by NordeaFonden and Det Obelske Familiefond. The funders had no role in the data collection, data analyses or interpretations of the findings in the study. Authors’ contributions HKR, SFV, IN and KSL conceived of the study. HKR and AKG collected the data. HKR, AKG and SFV analysed the qualitative data and HKR analysed the quantitative data and conducted the convergence analysis. All authors contributed to the interpretation of study results. 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Tables Table 1 Overview of data sources for the process evaluation and the research questions they inform Data source Process evaluation theme and the related key functions (Moore et al. 2015) Research questions answered by data ORGANISATIONAL SURVEY Implementation Dose • Did the families in the intervention clusters receive the postponed introduction to solid food Context Contextual factors that shape the implementation and how the intervention works • Did the intervention clusters have equal opportunity to deliver breastfeeding support as the control clusters? • What were the most important structural, physical, cultural, social and individual barriers and facilitators for the intervention? • Did the intervention clusters have important contextual factors that could impede or facilitate the implementation or delivery of the intervention? • If so, was this the case for control clusters as well? HEALTH VISITOR SURVEY Implementation Dose • What did the health visitors report having delivered? Reach • Did health visitors offer the intended intervention to families in each target group? If not, why? Adaptation • How did the intervention unfold in practice? Mechanisms of impact Reactions and interactions with the intervention • How did the health visitors respond to the intervention? Unexpected pathways and consequences • Did the intervention produce unanticipated effects or negative consequences? Context Contextual factors that shape the implementation and how the intervention works • Did health visitors participate in the training? • Was there contamination due to flux of staff across trial arms? • Did health visitors have managerial support for delivering the intervention? • Did health visitors have time to familiarise themselves with the intervention? HEALTH VISITOR RECORDS Implementation Dose • How many visits and telephone calls families have received? • Did families in intervention clusters receive more visits and telephone calls than families in control clusters? WEBSITE DATA Mechanisms of impact Reactions and interactions with the intervention • How did the families respond to the intervention? DIALOGUE MEETINGS Implementation Dose • Were there implementation issues regarding delivery of certain elements? Adaptation • What adaptations have been made to the intervention? And why? Mechanisms of impact Reactions and interactions with the intervention • How did the health visitors and the families respond to the intervention? Unexpected pathways and consequences • Did the intervention produce unanticipated effects or negative consequences? Context Contextual factors that shape the implementation and how the intervention works • What were the most important cultural, social and individual barriers and facilitators for the intervention? • What contextual factors affected (or was affected by) implementation, intervention mechanisms and outcomes? FOCUS GROUPS WITH HEALTH VISITORS Implementation Dose • What did the health visitors express having delivered? Reach • Did health visitors offer the intended intervention to families in each target group? If not, why? Adaptation • How did the intervention unfold in practice? Mechanisms of impact Reactions and interactions with the intervention • How did the health visitors and the families respond to the intervention? Mediators • Did the intervention work as planned? • Were the planned mechanisms of impact activated or did unforeseen mechanisms of impact occur? Unexpected pathways and consequences • Did the intervention produce unanticipated effects or negative consequences? Context Contextual factors that shape the implementation and how the intervention works • What were the most important structural, physical, cultural, social and individual barriers and facilitators for the intervention? • What contextual factors affected (or was affected by) implementation, intervention mechanisms and outcomes? • Was there causal mechanisms present in the context that acted to sustain the status quo or potentiate effects? INTERVIEWS WITH FAMILIES Implementation Dose • What did the families report having received? Reach • Did families in the target group for the intensified intervention receive the proactive telephone calls? If not, why? Mechanisms of impact Reactions and interactions with the intervention • How did the end-users (families) respond to the intervention? • Which impact did the intervention seem to have? Mediators • Did the intervention work as planned? • Were the planned mechanisms of impact activated or did unforeseen mechanisms of impact occur? Unexpected pathways and consequences • Did the intervention produce unanticipated effects or negative consequences? Context Contextual factors that shape the implementation and how the intervention works • What were the most important cultural, social and individual barriers and facilitators for the intervention? • What contextual factors affected (or was affected by) intervention mechanisms and outcomes? • Were there causal mechanisms present in the context that acted to sustain the status quo or potentiate effects? Table 2 Organisational contextual factors reported cross-s ectionally in March 2023, distributed on trial arms Control clusters (n = 10) Intervention clusters (n = 10) Mean (range) Mean (range) p -value* Number of newborns in 2021 627 (195–2390) 570 (348–1229) 0.724 Number of newborns in 2022 582 (138–2200) 518 (310–1150) 0.579 Shift in management since project start in 2021, n (%) 3 (30) 5 (50) 0.240 Number of health visitors employed, median (IQR) 15 (12–17) 13 (10–18) 0.868 Proportion of staff turnover during 2022, % 12 (0-28.6) 18 (0–50) 0.355 Number of IBCLCs employed, median (IQR) 2 (1–2) 2 (1–3) 0.653 Proportion reporting appointed specific health visitors handling the care of special groups, for instance young mothers, n (%) 7 (70) 4 (40) 0.150 Frequency of team meetings, n (%) Weekly Biweekly Monthly 3 (30) 4 (40) 3 (30) 4 (40) 1 (10) 5 (50) 0.053 Proportion of municipalities offering pregnancy visits, n (%) For primiparous families For multiparous families 8 (80) 6 (60) 9 (90) 8 (80) 0.395 0.244 Time allocated to pregnancy visits, minutes 78 (60–115) 80 (60–120) 0.977 Time allocated to first visit after birth, minutes 53 (30–90) 62 (30–90) 0.533 Estimated proportion of families in need of extra needs-based visits, % 36 (20–63) 29 (0–50) 0.512 Estimated proportion of families declining the health visiting programme in 2022, % 1 (0–5) 1 (0–2) 0.873 Abbreviations: IBCLC, International Board Certified Lactation Consultant; IQR, Interquartile Range *P-values are calculated using Wilcoxon rank sum test for categorical data and skewed continuous data, Fisher’s exact test for frequencies and t -test for normally distributed continuous data. Table 3 | Mean contacts per birth before and after implementation of the intervention across trial arms Pregnancy visits Number of visits Needs-based visits Telephone contacts Intervention clusters Before After Before After Before After Before After Cluster 1 0.4 0.5 ↑ 6.5 7.5 ↑ 1.9 2.5 ↑ 2.5 3.1 ↑ Cluster 2 n/a n/a 15.1* 19.5* ↑ --- --- 1.4 1.7 ↑ Cluster 3 0.6 1.1 ↑ 5.6 6.9 ↑ 1.1 1.2 ↑ n/a 0.5 ↑ Cluster 4 0.4 0.3 ↓ 6.0 6.2 ↑ 1.2 1.5 ↑ 1.5 1.8 ↑ Cluster 5 0.2 0.3 ↑ 5.3 5.7 ↑ n/a n/a 1.1 0.9 ↓ Cluster 6 0.3 0.6 ↑ 5.1 5.4 ↑ 1.4 1.2 ↓ 3.0 3.7 ↑ Cluster 7 0.5 0.9 ↑ 6.0 7.0 ↑ 1.5 1.9 ↑ 3.0 4.6 ↑ Cluster 8 0.5 0.6 ↑ 8.9 7.7 ↓ 1.3 1.0 ↓ 3.8 3.8 → Cluster 9 1.0 1.8 ↑ 5.5 6.5 ↑ 1.4 1.6 ↑ 2.9 4.1 ↑ Cluster 10 1.1 1.1 → 7.1 6.3 ↓ 2.3 1.6 ↓ 5.3 4.9 ↓ Control clusters Before After Before After Before After Before After Cluster 11 0.8 0.8 → 8.0 6.6 ↓ 2.0 1.6 ↓ 3.2 2.4 ↓ Cluster 12 0.2 0.3 ↑ 6.7 6.8 ↑ 1.4 1.4 → 2.4 2.7 ↑ Cluster 13 0.4 0.5 ↑ 6.4 7.3 ↑ 1.4 1.6 ↑ 2.2 2.0 ↓ Cluster 14 0.7 0.9 ↑ 5.7 6.3 ↑ 1.6 2.0 ↑ 2.3 2.4 ↑ Cluster 15 0.3 0.4 ↑ 6.5 6.1 ↓ 2.0 1.6 ↓ 1.1 1.3 ↑ Cluster 16 0.7 0.9 ↑ 5.6 5.8 ↑ 1.4 1.5 ↑ 4.1 3.9 ↓ Cluster 17 0.6 0.9 ↑ 6.4 6.2 ↓ 3.5 3.3 ↓ 2.1 2.0 ↓ Cluster 18 0.6 0.6 → 6.2 6.9 ↑ 1.4 1.2 ↓ 2.5 2.3 ↓ Cluster 19 0.5 0.5 → 6.9 7.0 ↑ 2.4 1.7 ↓ 3.1 3.6 ↑ Cluster 20 0.6 0.7 ↑ 4.9 5.3 ↑ 1.4 1.6 ↑ 0.5 0.4 ↓ Periods: Before = October 2021 – March 2022; After = August 2022 – July 2023; Intermediate = April 2022 – July 2022. The intermediate period is not reported to allow for an implementation period in the intervention clusters. The intervention clusters underwent training during March 2022 and began implementation the with implementation following completion of the training. *The specific electronic record system did not support extraction based on infants aged 0-6 months. Thus, numbers reported are higher than the remaining municipalities. Arrow pointing down indicates a drop, arrow pointing right indicates no change, while arrow pointing down indicates an increase in mean contact over time periods. Source: Health visitor records Table 4 Ten most popular webpages on the intervention website June 2022 - June 2023 Webpage Total visits in period Breastfeeding positions (video) 32830 Signs of thriving - the child's signs of hunger and satiety (video) 22838 Laid-back breastfeeding (video) 11322 Good suckling technique (video) 6775 Skin-to-skin principle to start over again with breastfeeding (video) 6681 Breastfeeding with nipple shield (video) 5029 Preparation for breastfeeding (video) 3671 Hand expression of breastmilk (video) 1283 Breastfeeding during the first period (video) 884 How breastfeeding works (physiological explanation) (video) 676 Table 5 Comparison of contextual elements reported by health visitors at follow-up. Both trial arms. Control group n = 150 Intervention group n = 134 Comparison n (%) n (%) p -value* How often did you discuss questions regarding breastfeeding with your colleagues during the past month? 0.009 Once or several times a week 60 (40) 64 (48) 1–3 times during the last month 80 (54) 64 (48) I have not discussed questions about breastfeeding during the last month 9 (6) 6 (5) Have you provided more or less needs-based visits than usual related to breastfeeding during the last six months? 0.001 More 25 (17) 42 (31) The same 116 (77) 76 (57) Less 0 (0) 1 (1) Not sure 9 (6) 15 (11) * P-values calculated using Fisher’s exact test Additional Declarations No competing interests reported. Supplementary Files AdditionalFile1Organisationalsurveyquestionnaires.docx AdditionalFile2HVsurveyquestionnaires.docx AdditionalFile3CONSORTclusterchecklist.docx AdditionalFile4SRQRChecklist.docx Cite Share Download PDF Status: Published Journal Publication published 08 Oct, 2024 Read the published version in International Journal for Equity in Health → Version 1 posted Editorial decision: Revision requested 21 Aug, 2024 Reviews received at journal 06 May, 2024 Reviewers agreed at journal 15 Apr, 2024 Reviewers agreed at journal 14 Jan, 2024 Reviewers agreed at journal 12 Jan, 2024 Reviewers invited by journal 11 Jan, 2024 Editor assigned by journal 29 Dec, 2023 Submission checks completed at journal 29 Dec, 2023 First submitted to journal 28 Dec, 2023 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3816186","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":264374411,"identity":"5fa76cee-250b-4cb5-9cbd-2b6b976b7b5e","order_by":0,"name":"Henriette Knold 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Copenhagen","correspondingAuthor":false,"prefix":"","firstName":"Anne","middleName":"Kristine","lastName":"Gadeberg","suffix":""},{"id":264374413,"identity":"6a5bc0d7-a8b6-434d-b7a0-2d11da9cc0c1","order_by":2,"name":"Katrine Strandberg-Larsen","email":"","orcid":"","institution":"University of Copenhagen","correspondingAuthor":false,"prefix":"","firstName":"Katrine","middleName":"","lastName":"Strandberg-Larsen","suffix":""},{"id":264374414,"identity":"8461da16-5d0a-4b22-b352-672f0616779a","order_by":3,"name":"Ingrid Maria Susanne Nilsson","email":"","orcid":"","institution":"The Danish Committee for Health Education","correspondingAuthor":false,"prefix":"","firstName":"Ingrid","middleName":"Maria Susanne","lastName":"Nilsson","suffix":""},{"id":264374415,"identity":"0971dc05-83e6-4525-b62a-8bb8309602e7","order_by":4,"name":"Sarah Fredsted Villadsen","email":"","orcid":"","institution":"University of Copenhagen","correspondingAuthor":false,"prefix":"","firstName":"Sarah","middleName":"Fredsted","lastName":"Villadsen","suffix":""}],"badges":[],"createdAt":"2023-12-28 10:29:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3816186/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3816186/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12939-024-02295-0","type":"published","date":"2024-10-08T15:58:06+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":49040374,"identity":"5c248ba5-e6ba-4134-9179-6a81b1411572","added_by":"auto","created_at":"2024-01-02 04:48:00","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":228289,"visible":true,"origin":"","legend":"\u003cp\u003eProgramme theory describing how the intervention activities are hypothesised to produce outputs and outcomes\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/ecc53cc008f446a5b635b3a2.png"},{"id":49040370,"identity":"e35356c0-e2ca-4c9b-b44e-e1bdd119e189","added_by":"auto","created_at":"2024-01-02 04:48:00","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":126955,"visible":true,"origin":"","legend":"\u003cp\u003eFlow diagram of heath visitor survey based on CONSORT\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/4574c26172172dc01859c87a.png"},{"id":49040371,"identity":"e854ffd7-155d-4040-8f3d-1e382497a26f","added_by":"auto","created_at":"2024-01-02 04:48:00","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":20982,"visible":true,"origin":"","legend":"\u003cp\u003eCoding tree – dialogue meetings with local representatives\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/0756768641027a05ecc53067.png"},{"id":49040373,"identity":"0b92e42e-da72-41d2-a237-c025cb735cc3","added_by":"auto","created_at":"2024-01-02 04:48:00","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":34772,"visible":true,"origin":"","legend":"\u003cp\u003eCoding tree – focus groups with health visitors\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/d407efc4cdb9102cfe4c0424.png"},{"id":49040592,"identity":"cdafdbb0-e21c-4ea6-9d41-21a151e8b33d","added_by":"auto","created_at":"2024-01-02 04:56:00","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":31542,"visible":true,"origin":"","legend":"\u003cp\u003eCoding tree – interviews with mothers\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/8426d4be0601c35df1cc1a33.png"},{"id":49040377,"identity":"10890246-7412-4b0f-a188-7c2d4c9276a9","added_by":"auto","created_at":"2024-01-02 04:48:00","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":28457,"visible":true,"origin":"","legend":"\u003cp\u003eHealth visitors’ self-reported assessment of the training programme and their breastfeeding support\u003c/p\u003e","description":"","filename":"6.png","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/e014d70ce991b9d30ed7c082.png"},{"id":49040382,"identity":"4daf5a3f-c644-49c0-b577-78ed0ae91439","added_by":"auto","created_at":"2024-01-02 04:48:01","extension":"png","order_by":7,"title":"Figure 7","display":"","copyAsset":false,"role":"figure","size":63513,"visible":true,"origin":"","legend":"\u003cp\u003eHealth visitors’ self-reported delivery of the intervention breastfeeding support\u003c/p\u003e","description":"","filename":"7.png","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/7d74529cd69cfd6c0fd63551.png"},{"id":49040596,"identity":"d4f54d8c-a5f2-4d65-aa52-eaeb59ffe3fa","added_by":"auto","created_at":"2024-01-02 04:56:00","extension":"png","order_by":8,"title":"Figure 8","display":"","copyAsset":false,"role":"figure","size":45591,"visible":true,"origin":"","legend":"\u003cp\u003eHealth visitors’ self-reported comparison of the intervention breastfeeding support to usual breastfeeding support (n=134)\u003c/p\u003e","description":"","filename":"8.png","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/6a220904e10552d8096cd8f2.png"},{"id":49040379,"identity":"7fcac460-31fc-4dc0-b199-3cbae39ecf28","added_by":"auto","created_at":"2024-01-02 04:48:00","extension":"png","order_by":9,"title":"Figure 9","display":"","copyAsset":false,"role":"figure","size":34859,"visible":true,"origin":"","legend":"\u003cp\u003eHealth visitors’ self-reported assessment of the intervention breastfeeding support (n=134)\u003c/p\u003e","description":"","filename":"9.png","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/baa82d6e42cd6d57d6a0edcb.png"},{"id":49040383,"identity":"ba6ded21-0f09-4c36-ae68-e4b2e9b10a70","added_by":"auto","created_at":"2024-01-02 04:48:01","extension":"png","order_by":10,"title":"Figure 10","display":"","copyAsset":false,"role":"figure","size":126145,"visible":true,"origin":"","legend":"\u003cp\u003eTotal visits* and time spent per visit on the intervention website June 2022-June 2023\u003c/p\u003e\n\u003cp\u003e* Around the beginning of April there was unfortunately an error on the website, which causes the graph to drop to zero in a period of about a fortnight until it was corrected\u003c/p\u003e","description":"","filename":"10.png","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/a52ff46d907f3e57986ad1e5.png"},{"id":49040385,"identity":"27a0fae1-2402-41e3-90e9-7a19a8f6adc1","added_by":"auto","created_at":"2024-01-02 04:48:02","extension":"png","order_by":11,"title":"Figure 11","display":"","copyAsset":false,"role":"figure","size":19580,"visible":true,"origin":"","legend":"\u003cp\u003eHealth visitors’ self-reported implementation of the intervention breastfeeding support (n=134)\u003c/p\u003e","description":"","filename":"11.png","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/ee91fe4998f3747c37f751e8.png"},{"id":66597305,"identity":"6606e2cf-4768-414e-aee5-ffeb0dc467b2","added_by":"auto","created_at":"2024-10-14 16:09:22","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2172748,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/bd471c60-7df3-42e4-bb92-65cd15dbf82a.pdf"},{"id":49040372,"identity":"f6b4540f-0d87-423b-b821-e549d0c1e823","added_by":"auto","created_at":"2024-01-02 04:48:00","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":25352,"visible":true,"origin":"","legend":"","description":"","filename":"AdditionalFile1Organisationalsurveyquestionnaires.docx","url":"https://assets-eu.researchsquare.com/files/rs-3816186/v1/3c69a8776474d8734b42dbca.docx"},{"id":49040914,"identity":"cda4a05a-41b7-410d-97ba-8a0206ec5bc6","added_by":"auto","created_at":"2024-01-02 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class=\"CitationRef\"\u003e2\u003c/span\u003e). In high-income countries, breastfeeding rates are suboptimal (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) and distributed unequally across socio-economic positions in favour of more advantaged groups (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). This also holds true in a Danish context (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Mothers ask for available and individual support from health professionals (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) which has been underscored as crucial for duration and exclusivity of breastfeeding (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Therefore, a breastfeeding support intervention: \u0026lsquo;Breastfeeding \u0026ndash; a good start together\u0026rsquo;, was rolled out during 2022\u0026ndash;2023 in a sample of 21 Danish municipalities (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) \u0026ndash; henceforth referred to as \u0026lsquo;the Breastfeeding Trial\u0026rsquo;.\u003c/p\u003e \u003cp\u003eIn the Breastfeeding Trial, health visitors in the intervention arm (n\u0026thinsp;=\u0026thinsp;11 clusters) received training to provide individualised breastfeeding support to new families, based on current evidence and theories such as self-efficacy, tailoring, and attributional retraining (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e), and aligned with the breastfeeding support implemented at hospital level (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). The aim of the intervention was to strengthen breastfeeding support and increase the proportion of women accomplishing their breastfeeding duration goals. An additional hypothesis proposed that delivering a higher dose of the intervention through proactive telephone calls (termed: \u0026lsquo;intensified intervention\u0026rsquo;) to families with young mothers and/or low educational attainment could help reduce social inequality in breastfeeding. In a pre- and post-test study we have documented that the training programme enhanced health visitors' knowledge, action competence, and self-efficacy related to breastfeeding support (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). The present study is a mixed-methods systematic process evaluation of the Breastfeeding Trial prior to the trial effectiveness evaluation.\u003c/p\u003e \u003cp\u003eComplex interventions like the Breastfeeding Trial are likely to reflect many causal assumptions. Identifying and stating these assumptions, or \u0026lsquo;programme theories\u0026rsquo;, is vital if process evaluation is to focus on the most important uncertainties that need to be addressed, and hence advance the understanding of the implementation and functioning of the intervention (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). The goal of a process evaluation is to illuminate the pathways linking what starts as an intervention and its hypothetical underlying causal assumptions to the outcomes produced in the end.\u003c/p\u003e \u003cp\u003eImplementation in this article refers to the quality and fidelity of the delivered intervention. By exploring the intricacies of the implementation of the Breastfeeding Trial, this study will contribute to examine the interplay between intervention components, implementation strategies and intended outcomes, to facilitate a deeper understanding of how and why the intervention produces effects, drawing into account the facilitators and barriers to delivering the intervention. The findings from this study will inform future, planned evaluations of the trial (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), and essentially assist policymakers and practitioners in deciding on potential scale-ups of the intervention, but the study also hold the potential to inform implementations of other breastfeeding interventions or community-based interventions.\u003c/p\u003e \u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003ch2\u003e1.1 | Aim and objectives\u003c/h2\u003e \u003cp\u003eWe aimed to assess the fidelity and quality of the implementation (dose, adaptations, reach) of the breastfeeding programme, and identify contextual factors in the health visitors\u0026rsquo; work acting as barriers and facilitators in the mechanisms of change. We investigated this by addressing the specific research questions, informed by the programme theory (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The research questions were as follows:\u003c/p\u003e \n\u003cul\u003e\n \u003cli\u003eWas the intervention delivered as planned?\u003cul\u003e\n \u003cli\u003eTo whom?\u003c/li\u003e\n \u003cli\u003eWhat elements?\u003c/li\u003e\n \u003cli\u003eWhat adaptations were made?\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/li\u003e\n \u003cli\u003eWhat were the reactions and interactions with the intervention?\u003c/li\u003e\n\u003c/ul\u003e\n\u003cul\u003e\n \u003cli\u003eAmong health visitors\u003c/li\u003e\n \u003cli\u003eAmong families\u003c/li\u003e\n \u003cli\u003eWere there any unintended effects related to the intervention?\u003c/li\u003e\n \u003cli\u003eWhat contextual factors were important for the intervention to be implemented and delivered as planned?\u003cul\u003e\n \u003cli\u003eWhat impeded or facilitated the delivery of the intervention and the mechanisms of change?\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/li\u003e\n\u003c/ul\u003e"},{"header":"2 | The Framework of the Intervention","content":"\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e2.1 | Setting\u003c/h2\u003e \u003cp\u003eIn the present trial, the cluster units are municipalities. Municipalities are local areas of government with an array of responsibilities, including primary health care and prevention for children, under which the health visiting programme falls (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). In Denmark, all mothers and their newborn infants are discharged from hospital after birth to a follow-up programme delivered by health visitors employed in health visiting programmes of the municipalities. The health visiting programme mainly takes place in families\u0026rsquo; homes, is a tax-based offer and is largely accepted by more than 97% of new families (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Health visitors are registered nurses with an additional 18-month post-graduate education in promoting healthy families (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e), including provisioning of breastfeeding support. In this setting, the present intervention was implemented.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e2.2 | The intended intervention and implementation\u003c/h2\u003e \u003cp\u003eThe intervention focussed on a strengthened breastfeeding support and included an 18 h skills training programme for health visitors encompassing breastfeeding physiology, breastfeeding support and tailoring of communication, among other things. Delivering a pregnancy visit to ensure parents\u0026rsquo; breastfeeding preparation was part of the intervention. To support the intervention, materials were developed, including a dialogue sheet, a postcard, a pamphlet, and a website with guiding videos, podcasts and quizzes. Furthermore, the usual care four-month visit with guidance on how to introduce solid foods in the infant\u0026rsquo;s diet was to be postponed where possible to prolong exclusive breastfeeding. Thus, the ordinary four-month visit was replaced with a telephone call in which the individual parents\u0026rsquo; needs regarding the introduction of solids were assessed. Health visitors in the intervention clusters were instructed to hand out the materials to new families and provide simple, evidence-based breastfeeding support (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The intervention has been described in detail elsewhere (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), as has the training programme (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). The four key messages in the intervention: 1) breastfeeding as a joint parenting task, 2) skin-to-skin contact, 3) proper breastfeeding positioning and 4) frequent breastfeeding, are evidence-based and have previously produced results in the \u0026lsquo;Less is More\u0026rsquo; trial carried out in Danish maternity wards (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). It was subsequently politically decided to implement \u0026lsquo;Less is More\u0026rsquo; throughout Danish maternity wards (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). The proactive telephone calls for mothers of young age or with low educational attainment, was inspired by an intervention study in which frequent telephone calls for mothers with pre-pregnancy BMI\u0026thinsp;\u0026ge;\u0026thinsp;30, who often have difficulties breastfeeding, were found to be effective for prolonging breastfeeding (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eInvitation to participate in the Breastfeeding Trial was addressed to managers of the health visiting programmes in the municipalities in the North Denmark Region and Region of Southern Denmark. In municipalities accepting participation, one or two local project representatives (depending upon numbers of newborns in the municipality) were appointed, with financial compensation from the project funds, to act as day-to-day project coordinators. Monthly dialogue meetings were held between intervention developers and local representatives from intervention clusters, during which issues regarding implementation and the intervention could be discussed. The dialogue meetings underpinned the implementation and were continually held from April 2022 until September 2023.\u003c/p\u003e \u003c/div\u003e"},{"header":"3 | Materials and Methods","content":"\u003cp\u003eA mixed-methods design (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e) was planned to comprehensively answer our research questions, and the Medical Research Counsel (MRC) framework for conducting process evaluations guided our assessment of the implementation (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Process evaluations provide valuable insights into the \u0026lsquo;black box\u0026rsquo; of contextual factors, delivery mechanisms, and fidelity of an intervention, uncovering critical factors that may influence intervention outcomes, and thus shed light on the intervention\u0026rsquo;s effectiveness and potential for scalability (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Furthermore, they help to reveal unanticipated consequences and offer insights for the optimal integration of these interventions into existing practices (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe CONSORT statement: extension to cluster randomised trials (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) and the Standards for Reporting Qualitative Research (SRQR) (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) guided the study reporting.\u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003e3.1 | Data sources\u003c/h2\u003e \u003cp\u003eThe data sources are described in detail below, divided into whether collection was completed throughout all project clusters or in intervention clusters only. A full list of data sources and which research questions they inform is provided in Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section3\"\u003e \u003ch2\u003e3.1.1 | Data collected in all clusters\u003c/h2\u003e \u003cp\u003e \u003cem\u003eOrganisational survey\u003c/em\u003e \u003c/p\u003e \u003cp\u003eIn early 2023, an organisational survey was distributed electronically to managers of the health visiting programmes in all municipalities. Because one intervention cluster dropped out immediately after the training programme, this cluster was omitted from the survey. The survey focused on the local and organisational context, and included the following themes: 1) management and size of the health visiting programme, 2) organisation of visits in the health visiting programme, prespecified according to the recommendations by the Danish National Board of Health, 3) estimation of the proportion in need of extra visits, and 4) organisation of staff, team meetings and conditions possibly impacting staff resources, and the managers were asked to reply based on their current programme. A full overview of the questions included in the questionnaire can be found in Additional File 1.\u003c/p\u003e \u003cp\u003e \u003cem\u003eHealth visitor survey\u003c/em\u003e \u003c/p\u003e \u003cp\u003eElectronic questionnaires were distributed to all health visitors employed in the participating municipalities: 1) at baseline: prior to training in December 2021, and 2) at follow-up: in October 2022 six months after training. Themes in the survey questionnaires were: 1) background and education, 2) breastfeeding support, attitudes, and practices in relation to breastfeeding support and self-reported relationships with families. Additionally, health visitors in the intervention arm were asked about their experience with the intervention, the training programme and the intervention material (for example experiences with and attitudes towards) at follow-up. Full overview of the questions included in the surveys, timepoints for distribution and recipients can be found in Additional File 2.\u003c/p\u003e \u003cp\u003e \u003cem\u003eHealth visitor records\u003c/em\u003e \u003c/p\u003e \u003cp\u003eAverage visits and telephone calls per mother-infant dyad per month were collected from the health visitor records in each municipality.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e \u003ch2\u003e3.1.2 | Additional data from clusters in the intervention arm only\u003c/h2\u003e \u003cp\u003e \u003cem\u003eWebsite logins\u003c/em\u003e \u003c/p\u003e \u003cp\u003eUse of the website was monitored by simple analytics providing number of logins with few options available for data extraction and no option for filtering data on municipality. Data accessible were most used unit of access (smart telephone vs. computer), average time spent during visits and most popular webpages on the website. Data from the intervention website was extracted of a one-year period from 1 June 2022 to 1 June 2023.\u003c/p\u003e \u003cp\u003e \u003cem\u003eFocus groups with health visitors\u003c/em\u003e \u003c/p\u003e \u003cp\u003eThree semi-structured, online focus groups were conducted. Two health visitors from each of the municipalities in the intervention arm, not already appointed as local representative, were invited.\u003c/p\u003e \u003cp\u003e \u003cem\u003eInterviews with parents \u0026ndash; predominately mothers\u003c/em\u003e \u003c/p\u003e \u003cp\u003eEight semi-structured interviews with mothers, one including both parents, and sampled from two of the intervention sites were conducted. Interviews were conducted either face to face in parents\u0026rsquo; home (n\u0026thinsp;=\u0026thinsp;5) or over the telephone (n\u0026thinsp;=\u0026thinsp;3), depending on the interviewees\u0026rsquo; preferences.\u003c/p\u003e \u003cp\u003e \u003cem\u003eDialogue meetings\u003c/em\u003e \u003c/p\u003e \u003cp\u003e Minutes and observations from the first seven of a total of 13 dialogue meetings informed the present process evaluation, during which a representative from the evaluation team participated in an observer role.\u003c/p\u003e \u003cp\u003e\u0026loz; Insert Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003e3.3 | Analysis\u003c/h2\u003e \u003cp\u003eIn the present study, the analysis was guided by the MRC Process Evaluation of Complex Interventions framework (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) and by the research questions specified above.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section3\"\u003e \u003ch2\u003e3.3.1 | Quantitative data\u003c/h2\u003e \u003cp\u003eQuantitative data were analysed descriptively and presented graphically. For comparisons of means, frequencies and medians across trial arms, Welch\u0026rsquo;s \u003cem\u003et\u003c/em\u003e-test, Chi-square, Fisher\u0026rsquo;s Exact test or one-way ANOVA on ranks test were used. Analyses were done using SAS statistical software (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e \u003ch2\u003e3.3.2 | Qualitative data and analytical approach\u003c/h2\u003e \u003cp\u003eThe individual interviews were conducted by HKR, who also moderated the focus groups, assisted by AKG as an observant. Qualitative data was analysed using Systematic Text Condensation (STC) focusing on participants\u0026rsquo; expressed experiences (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). HKR, AKG and SFV discussed the transcripts and the initial coding. Coding was carried out using NVivo 14 software (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section3\"\u003e \u003ch2\u003e3.3.3 | Integration of findings\u003c/h2\u003e \u003cp\u003eInitial thorough analyses were conducted of each data source. Subsequently, using mixed-methods convergent design, integration of findings data sources was completed to compare findings\u0026rsquo; convergence, divergence or complementarity and thereby gain an in-depth and comprehensive answer to the research questions (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). The aim was to provide a general impression of the fidelity to the intervention in the context in which it was implemented.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"4 | Results","content":"\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003e4.1 | Response rates and participants\u003c/h2\u003e \u003cp\u003eAll managers of the project municipalities (n\u0026thinsp;=\u0026thinsp;20) responded to the organisational survey, yielding a response rate of 100%. Data are provided in Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e→ Insert Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u003c/p\u003e \u003cp\u003eThe health visitor survey was distributed to 368 health visitors at baseline, and 351 health visitors at follow-up. Figure\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e presents a detailed flow diagram of the inclusion and attrition of participants in the survey waves. The response rates in the control arm and the intervention arm were 82% and 89% at baseline respectively, and 81% in both arms at follow-up, and 242 health visitors completed both baseline and follow-up, of which three changed trial-arm. The results are based on follow-up responses, except for Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003eb in which self-reported assessment of breastfeeding support is based on the complete responses in the intervention arm.\u003c/p\u003e \u003cp\u003eData from health visitor records were obtained from all municipalities (n\u0026thinsp;=\u0026thinsp;20).\u003c/p\u003e \u003cp\u003e In dialogue meetings, all local representatives participated if possible (n\u0026thinsp;=\u0026thinsp;13). In the seven meetings analysed, 12\u0026ndash;13 local representatives participated in each. A coding tree of the analysis can be seen in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e \u003cp\u003eSixteen health visitors participated in the three focus groups, with four to seven participants in each. Four out of 10 municipalities participated with only one participant. Participants had between six months and 31 years of experience as a health visitor, two held an International Board Certified Lactation Consultant (IBCLC) degree, and one had not participated in the training programme (data not shown). A coding tree of the analysis of focus groups can be viewed in Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e.\u003c/p\u003e \u003cp\u003eIn the interviews with mothers, eight mothers and one father participated. Five mothers were eligible for intensified intervention, and four had accepted the offer. Mothers age ranged from 21\u0026ndash;32, and the infants\u0026rsquo; age at interview ranged from \u0026lt;\u0026thinsp;1\u0026ndash;9 months (median 4 months). Four had either primary school or vocational education, one had secondary education and three had tertiary education as highest educational attainment. All participants were in a cohabitating relationship or married, three were primiparous and the rest multiparous. Five interviews were conducted face-to-face and three via telephone. A coding tree of the analysis of interviews can be found in Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e4.2 | Implementation \u0026ndash; \u003cem\u003eWas the intervention delivered as planned \u0026ndash; to whom, what elements and were adaptations made?\u003c/em\u003e\u003c/p\u003e \u003cdiv id=\"Sec16\" class=\"Section3\"\u003e \u003ch2\u003e4.2.1 | The training programme\u003c/h2\u003e \u003cp\u003eOf the 134 health visitors in the intervention arm responding at follow-up, 90% (n\u0026thinsp;=\u0026thinsp;120) responded to have participated in full, while two (1%) had participated in parts of the breastfeeding support training programme (data not shown). Twelve (9%) had not participated at all. Reasons for not participating in the training were \u0026lsquo;\u003cem\u003enot employed at the time\u003c/em\u003e\u0026rsquo; (n\u0026thinsp;=\u0026thinsp;7) and \u0026lsquo;\u003cem\u003eleave\u003c/em\u003e\u0026rsquo; (n\u0026thinsp;=\u0026thinsp;5) (data not shown). Of the 12 non-participants, 11 reported having received one-to-one education from a colleague at the least. The remaining health visitor had not received any training (data not shown). Of the respondents in the intervention arm, 83% felt that the training had provided them the ability to deliver breastfeeding support in accordance with the intervention (Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003ea).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section3\"\u003e \u003ch2\u003e4.2.2 | The breastfeeding support\u003c/h2\u003e \u003cp\u003eMost health visitors in the intervention arm reported that it had been their intention to guide and that they had in fact guided in accordance with the intervention, and that they furthermore intended to continue guiding in accordance with the intervention (Fig.\u0026nbsp;\u003cspan refid=\"Fig7\" class=\"InternalRef\"\u003e7\u003c/span\u003ea), underlining the health visitors\u0026rsquo; acceptance of the intervention.\u003c/p\u003e \u003cp\u003eIn the focus groups, health visitors expressed that the intervention breastfeeding support was aligned with their previous support, however simpler and therefore clearer. The four key messages, they expressed, helped them to structure the support and remember the most important things.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026ldquo;We really want to support breastfeeding, so we also thought it was valuable if we could do something to increase the breastfeeding rate. That\u0026rsquo;s what motivates us [\u0026hellip;]\u0026rdquo;\u003c/em\u003e (Health visitor 1)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eIn Fig.\u0026nbsp;\u003cspan refid=\"Fig7\" class=\"InternalRef\"\u003e7\u003c/span\u003eb, responses to questions regarding specific theory- and evidence-based elements that was part of the intervention is presented. Also here, most health visitors (90\u0026ndash;98%) reported that they \u0026lsquo;\u003cem\u003eoften\u003c/em\u003e\u0026rsquo; or \u0026lsquo;\u003cem\u003ealmost always\u0026rsquo;\u003c/em\u003e had delivered support in alignment with the intervention (Fig.\u0026nbsp;\u003cspan refid=\"Fig7\" class=\"InternalRef\"\u003e7\u003c/span\u003eb). This was confirmed by qualitative data, where the health visitors described that they had tailored the information to fit parents\u0026rsquo; needs, and that they had delivered the postcard, the check-the-milk pamphlet and the project website to all the families they encountered, furthermore confirmed by mothers participating in the interviews.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;I think that the simpler it is with such a card (the postcard), the easier it is for them to comprehend. So even if you ask if we support the same way as usually? Yes, to some extent, but it is a good tool because we get to add something illustrative, and I think we lacked that before. And it helps underline the importance of it.\u0026rdquo;\u003c/em\u003e (Health visitor 2)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eThe exception was the dialogue sheet. During the first dialogue meetings, local representatives had expressed that health visitors found it difficult to implement and use, especially if they had to use it after birth when there were many infant specific tasks to be completed during visits and little time. Therefore, the intervention developers and the local representatives had agreed to only use the dialogue sheet in pregnancy visits. Still, the delivery continued to be incomplete; just a couple of health visitors in focus groups expressed to have found the sheet useful, whereas the remaining participants believed that the sheet just duplicated the obtainment of families\u0026rsquo; individual histories in the electronic record system usually done during pregnancy visits. Interview findings also confirmed this, as only two mothers had encountered the sheet.\u003c/p\u003e \u003cp\u003eIn municipalities that had not previously had pregnancy visits as part of their usual care, pregnancy visits had been in demand as expressed by local representatives in dialogue meetings and by health visitors in focus groups. This made them easy to implement. Health visitor records showed an increase in most intervention clusters (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e), thereby confirming the easy implementation. However, increases were also found in most control clusters (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e→ Insert Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e\u003c/p\u003e \u003cp\u003eIn interviews, a few mothers told of situations where the delivered breastfeeding support had acted against the intended intervention. For instance, a few mothers had been guided to try to space out feedings to counteract an infant\u0026rsquo;s rapid weight gain, and another had been told that it was normal to experience pain related to breastfeeding in the beginning.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026ldquo;When I asked my health visitor, she said that it was normal for breastfeeding to hurt in the beginning, because my body isn\u0026rsquo;t used to it and things like that. But that it at least should get better. It did when I was almost finished breastfeeding. But in the end, it ran out (the milk). [\u0026hellip;].\u0026rdquo;\u003c/em\u003e (Mother 3)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section3\"\u003e \u003ch2\u003e4.2.3 | The intensified intervention\u003c/h2\u003e \u003cp\u003eAnother adaptation found across the qualitative data was the intensified intervention. During dialogue meetings, representatives expressed that health visitors in their teams wished to be able to adapt the delivery mode to include text messages in addition to the planned telephone calls, and that some had found it difficult to find a good way of voicing the reasons behind the offer of the intensified intervention to mothers in the target group without stigmatising them. Mothers confirmed the adaptation of the communication mode and expressed that they had received the planned intervention. Findings from the focus groups expanded these findings in that some health visitors found it easier than others to deliver the offer of the intensified intervention. Finding one\u0026rsquo;s own way of voicing the offer seemed to be key. Health visitors also talked about situations where they had refrained from offering the intensified intervention. In these situations, they had made a judgment call to prioritise other, more pressing circumstances than offering the intensified intervention, or they anticipated that a specific family would not have the resources to focus that much on breastfeeding.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026rdquo;I think it depends on how well you \u0026rsquo;sell it\u0026rsquo; (the intensified intervention), and I think that some considers: \u0026lsquo;In this particular family, there is no point in even introducing it\u0026rsquo;. At least in our team, when we discussed it yesterday, some of my colleagues had no families in the intensified intervention, because they had reasoned: \u0026lsquo;They are not able to\u0026hellip; It will be too much\u0026rsquo;. And so, the families may not even get the offer\u0026rdquo;.\u003c/em\u003e (Health visitor 1)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eFurthermore, health visitors expressed some frustration about the necessity of developing their own unique system to deliver the proactive calls in alignment with the plan and that they would sometimes adapt the scheduled contacts to fit their calendars, for example when a holiday would come up. Some would in such a case offer the contacts before or after the scheduled contact to avoid having colleagues take over, while others would leave it up to a colleague to handle. Health visitor records were highly ambiguous, however had a tendency towards convergence in that the mean number of telephone contacts increased in seven out of the 10 intervention clusters after the implementation of the intervention, whereas this was the case for less than half of the control clusters (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). This also suggests that contamination regarding the intensified intervention across trial arms was unlikely.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section3\"\u003e \u003ch2\u003e4.2.4 | Postponing the introduction of solid food\u003c/h2\u003e \u003cp\u003eImplementation of the postponed four-month visit was reported by managers in the organisational survey to have been successful, although sometimes difficult to implement due to barriers related to families\u0026rsquo; context to be elaborated below (data not shown).\u003c/p\u003e \u003cp\u003e4.3 | Mechanisms of impact \u0026ndash; \u003cem\u003eWhat were the reactions and interactions with the intervention \u0026ndash; among health visitors, among families, and were there any adverse effects related to the intervention?\u003c/em\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section3\"\u003e \u003ch2\u003e4.3.1 | The breastfeeding support\u003c/h2\u003e \u003cp\u003eMost health visitors (71%) with complete responses, felt that their breastfeeding support had improved since the implementation of the intervention, while some felt that their support had not changed (28%) or even worsened (1%) (Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003eb). Health visitors largely believed the intervention was superior to usual breastfeeding support in establishing breastfeeding to ensure the infant\u0026rsquo;s thriving (76%, Fig.\u0026nbsp;\u003cspan refid=\"Fig8\" class=\"InternalRef\"\u003e8\u003c/span\u003ea) and in strengthening parents\u0026rsquo; belief that they could breastfeeding exclusively for four months (62%, Fig.\u0026nbsp;\u003cspan refid=\"Fig8\" class=\"InternalRef\"\u003e8\u003c/span\u003eb), while 23% and 37%, respectively, found it equal to usual breastfeeding support. Regarding relationship formation with families and number of inquiries from families since the intervention commenced, health visitors largely reported the intervention to produce similar effects as the usual breastfeeding support (78% and 69%, respectively, Fig.\u0026nbsp;\u003cspan refid=\"Fig8\" class=\"InternalRef\"\u003e8\u003c/span\u003ec-d).\u003c/p\u003e \u003cp\u003eConfirming these findings, health visitors in focus groups expressed that the intervention fit well within their usual practice and that the training programme had enabled them to apply in-depth knowledge about for example mechanisms for milk production to their existing support.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u0026ldquo;\u003cem\u003eI feel that I had a lot of my knowledge confirmed during the training programme and gained some. I think it was good and I now provide the appropriate information depending on the family\u003c/em\u003e\u0026rsquo;\u003cem\u003es needs.\u0026rdquo;\u003c/em\u003e (Health visitor 8)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eMoreover, some health visitors expressed in focus groups to have focussed more on laid-back breastfeeding positioning and on the skin-to-skin approach when supporting families. All expressed satisfaction with the intervention materials, i.e., the postcard, Check-the-Milk pamphlet etc., which they considered appealing and felt had been missing, and further facilitated the provision of support via telephone. The postcard with the four key messages on the front and a website login on the back structured and simplified the breastfeeding support in that it helped health visitors remember to focus on the important things. Confirming this sentiment, in the survey, most health visitors reported that providing breastfeeding support in alignment with the intervention was simpler than before (46%) or the same as before (45%) (Fig.\u0026nbsp;\u003cspan refid=\"Fig9\" class=\"InternalRef\"\u003e9\u003c/span\u003e). Mothers in interviews were happy with the breastfeeding support they had received, except for the few accounts mentioned above, where the advice and support provided had been in discordance with the intervention. Still, in those cases the dissatisfaction seemed brief. Using the skin-to-skin approach to solve breastfeeding problems was advised in alignment with the intervention and had been successfully applied by a couple of mothers.\u003c/p\u003e\u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section3\"\u003e \u003ch2\u003e4.3.2 | Interactions with the intervention materials\u003c/h2\u003e \u003cp\u003eAs described in the previous section about implementation, in the qualitative data, health visitors\u0026rsquo; reactions to the dialogue sheet were mostly frustration. They generally felt micromanaged to do a task they believed they already covered. A few health visitors disconfirmed this by having found the sheet useful and to facilitate a deeper understanding for the families\u0026rsquo; situations, in convergence with accounts from the few mothers who had encountered the sheet.\u003c/p\u003e \u003cp\u003eHealth visitors in the focus groups and dialogue meetings found the intervention website useful and expressed that sound, evidence-based knowledge about breastfeeding in Danish had been in demand. They were surprised that to their experiences, families seemed to not have utilized the website much. Website data showed that there had been more than 35,000 visits during a one-year period and confirmed that most logons (86%) had spent up to one minute (Fig.\u0026nbsp;\u003cspan refid=\"Fig10\" class=\"InternalRef\"\u003e10\u003c/span\u003e), which might cover health visitors\u0026rsquo; introduction of the website to families, and the families\u0026rsquo; independent logons to give the website a quick browse. However, further 11% of visitors spent between one to 10 minutes on the visit, while the remaining 3% spent 10\u0026ndash;30 minutes or beyond (Fig.\u0026nbsp;\u003cspan refid=\"Fig10\" class=\"InternalRef\"\u003e10\u003c/span\u003e). Thus, even though website data confirmed most visits to be short, a considerable proportion, corresponding to more than 5,000 visits during a one-year period, lasted more than 10 minutes. This suggests that families with interests, utilised the website accordingly.\u003c/p\u003e \u003cp\u003eThis heterogenic use of the site was supported by interview data, as most mothers had taken a quick look, but also that some had spent a lot of time on it. The mothers generally expressed that the many videos on the website offered useful support in a timely manner. Viewing videos was expressed as easier than reading under the circumstances of having an infant on the arm, although some mothers with high educational attainment found other available material on the website useful, for example texts and podcasts.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026ldquo;Yeah, so if there was something we doubted, then he (the father) was the one reading about it and then passing on the information. So, he has used it (the website).\u0026rdquo;\u003c/em\u003e (Mother 6)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eData from the website supported this inclination towards the videos with the ten most visited pages all being videos (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). During dialogue meetings and in focus groups, health visitors were disappointed about the lack of a search option on the website and speculated that a smartphone application would have been used more, however, interview data offered no insights on the matter. Health visitors expressed a wish for continued use of the project website and postcard after the project finished, and interview data confirmed this, as mothers who had found good use of the intervention website deeply wished to have continued access and wanted everyone to gain access.\u003c/p\u003e \u003cp\u003e→ Insert Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section3\"\u003e \u003ch2\u003e4.3.3 | The importance of preparation for breastfeeding\u003c/h2\u003e \u003cp\u003eIn focus groups, health visitors expressed that a pregnancy visit was an important element in the intervention, providing an occasion to form a relationship with the families and to scope families\u0026rsquo; wishes and intentions towards breastfeeding before the arrival of the infant after which challenges and emotions could lead to forgotten intentions. It provided a unique opportunity to tailor breastfeeding support by encouraging and guiding families based on their formerly expressed wishes and their current needs.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026ldquo;I find it important when we are on pregnancy visits to ask them when you hold the postcard: \u0026lsquo;What do you think? Do you feel like breastfeeding? Did you talk about it?\u0026rsquo; [\u0026hellip;]. So that it is a choice and not something that I tell them to do. I think it is important, because then you have a chat about if they want to and how strongly they feel about it. [\u0026hellip;]. I think it is so important that you kind of balance it out: \u0026lsquo;What was it that we talked about back then, when they didn\u0026rsquo;t have those sore breasts and cracks and bleeding and were tired\u0026rsquo;\u0026rdquo;\u003c/em\u003e (Health visitor 1)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eData from interviews confirmed this, and one mother explicitly expressed how the health visitor\u0026rsquo;s knowledge of the mother\u0026rsquo;s expressed wishes from before things got challenging, led to encouragement to try again at the right time, consequently facilitating continued breastfeeding that would have otherwise been discontinued.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003e4.3.4 | The intensified intervention\u003c/h2\u003e \u003cp\u003eThe intensified intervention was believed to be time-consuming in both focus groups and dialogue meetings, although conversely, in a few exceptions, health visitors expressed that it preserved time. The health visitors found that the fixed structure of delivering the extra care in the intensified intervention needed development of a systematic approach for it to fit into their individual planning. Health visitors\u0026rsquo; reactions to the intensified intervention covered a spectrum of \u0026lsquo;time-consuming waste of time\u0026rsquo; to \u0026lsquo;it works really well\u0026rsquo;. In the former, it was believed that families who experienced needs would reach out themselves, thereby rendering the proactive approach superfluous. In the latter, health visitors had experienced being included in discussions of discontinuation of breastfeeding and believed to have been able to postpone the cessation due to the intensified intervention. They expressed that they were able to prevent discontinuation in multiparous families who \u0026lsquo;usually\u0026rsquo; started bottle-feeding at certain time points. Furthermore, in families with concerns about sufficient milk supply due to the sudden emergence of more frequent feedings, they could articulate that infants increase the milk production according to their demand and that this probably was the reason for the changed feeding pattern. If nothing more, they said, they would have at least provided a pat on the back and a sense of security, and thus afforded parents an extra motivation to keep on breastfeeding.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e[\u0026hellip;] I have been contacted by parents in the intensified interventions: \u0026lsquo;We just want to ask you what you think \u0026ndash; would it be okay to bottle-feed tonight?\u0026rsquo;. [\u0026hellip;] I have been able to prolong the breastfeeding by informing them: \u0026lsquo;Well, a lot is happening with your child emotionally and that\u0026rsquo;s why the baby wakes up and cries out for you more \u0026ndash; it\u0026rsquo;s not just about the breastfeeding\u0026rsquo;. [\u0026hellip;] Or: \u0026lsquo;The baby eats faster now and gets more milk at a time, and that\u0026rsquo;s why the feedings are quicker now.\u0026rsquo;\u003c/p\u003e\u003cp\u003e(Health visitor 11)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eData from interviewed mothers expanded focus group findings with information about how the frequent contacts from the health visitor made them feel that it would be no inconvenience if they themselves needed to contact the health visitor.\u003c/p\u003e \u003cp\u003eHealth visitors believed that the proactive telephone calls could potentially preserve time in cases where they would usually provide a needs-based visit \u0026lsquo;just in case\u0026rsquo;. In the future, they foresaw using the telephone calls to explore needs for a visit instead. They agreed that although the intensified intervention could be warranted in certain cases, the responsibility for identifying which should be up to the health visitors\u0026rsquo; professional judgment.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec24\" class=\"Section3\"\u003e \u003ch2\u003e4.3.5 | Postponing the introduction of solid food\u003c/h2\u003e \u003cp\u003eThe postponement of the four-month visit was discussed in both dialogue meetings and focus groups. In dialogue meetings, the local representatives were worried that a postponement could result in inadvertent consequences by delaying the detection of inadequate motor-skills in infants. Expanding this, health visitors in focus groups expressed that in practice it could be difficult to postpone the visit, because families, especially multiparous-, expected a four-month visit, or because some families, especially primiparous-, were eager to begin introducing solids into the infant\u0026rsquo;s diet. The organisational survey offered the managers\u0026rsquo; view of the uptake, which was overall positive, even with expressed wishes to keep the practice after the intervention ended, and health visitors in the focus group overall found the postponement meaningful. Interview data were silent on this matter.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003e4.3.6 | Possible adverse effects\u003c/h2\u003e \u003cp\u003eDuring dialogue meetings and in focus groups, concerns were raised about the risk of stigmatising mothers in the target group for intensified intervention by voicing the eligibility criteria. However, this was refuted, as the interviewed mothers did not express to have felt stigmatised. Some had not fully comprehended the motives for the offer. Confirming this, in a focus group one health visitor said that her manager had helped the team overcome the barrier for offering the intensified intervention by telling them to simply leave out reasons for the offer. Another concern raised in focus groups, was that the intensified intervention might inadvertently introduce insecurities in mothers if they interpreted telephone calls as a form of monitoring. Again, interview data disproved this, as mothers said that the close follow-up had stimulated a sense of security.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026rdquo;Yeah, I thought it was super nice (receiving the proactive calls). I remember being a bit nervous about \u0026lsquo;oh no, will I be judged for being\u0026hellip; you know\u0026hellip; young\u0026rsquo;. But she was super nice, and it was quite comforting to know, like\u0026hellip; Because she ensures me that she is only trying to help me. [\u0026hellip;] It felt very safe for me, I think [\u0026hellip;].\u0026rdquo;\u003c/em\u003e (Mother 2)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003e4.4 | Context \u0026ndash; \u003cem\u003eWhat contextual factors were important for the intervention to be implemented and delivered as planned \u0026ndash; what impeded or facilitated the delivery of the intervention and the mechanisms of change?\u003c/em\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec26\" class=\"Section3\"\u003e \u003ch2\u003e4.4.1 | Organisational context\u003c/h2\u003e \u003cp\u003eIn both trial arms there had been shifts in management and turnover of staff during the project period (Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Despite statistical insignificant differences between groups, proportions were visually higher in the intervention arm with 50% of management and 18% of staff had been replaced since project start, compared to 30% and 12%, respectively. In focus groups, health visitors expressed the importance of management for the implementation, for instance by adapting project tasks such as recruitment to fit the context or by prioritising resources to the project. Participation in the training programme would instil a sense of ownership in the health visitors. Therefore, newly employed health visitors could end up impeding intervention implementation and delivery and some health visitors did indeed point out variation in colleagues\u0026rsquo; attitude towards the intervention, they expressed. In the survey among health visitors, only a few had not participated in the training programme as mentioned above and responses suggested that most had felt some extent of managerial support in the intervention (Fig.\u0026nbsp;\u003cspan refid=\"Fig11\" class=\"InternalRef\"\u003e11\u003c/span\u003ea), thereby disconfirming that lack of managerial support and sense of ownership might have threatened the intervention delivery. Moreover, health visitors largely reported that they had had time to familiarise themselves with the intervention and had read most of the intervention manual (Fig.\u0026nbsp;\u003cspan refid=\"Fig11\" class=\"InternalRef\"\u003e11\u003c/span\u003eb-c), indicating that the organisations had allocated the resources necessary to implement the intervention.\u003c/p\u003e \u003cp\u003eTwo other organisational factors that affected the implementation were workload and financial resources. In focus groups, health visitors expressed how the workload of the intensified intervention would be distributed unequally within teams due to differences in the population composition in each health visitors\u0026rsquo; assigned district. Data from the organisational survey showed that almost twice as many municipalities in the control arm had health visitors appointed especially to handle the care of a specific group, for instance young mothers or mothers of low educational attainment (control group: 70% vs. intervention group: 40%), despite the difference being statistically insignificant (Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Financial cutbacks to the health visiting programme put pressure on available resources and on the individual health visitors, thereby impeding the implementation, as it was pointed out by focus group participants.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec27\" class=\"Section3\"\u003e \u003ch2\u003e4.4.2 | The impact of local representatives\u003c/h2\u003e \u003cp\u003eData from the survey among health visitors showed more frequent discussions with colleagues about breastfeeding in the intervention arm than in the control arm (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e5\u003c/span\u003e), which adds information to the findings from the organisational survey, in which managers reported frequency of team meetings (Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e→ Insert Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e5\u003c/span\u003e\u003c/p\u003e \u003cp\u003e In dialogue meetings, it became apparent that resourceful local representatives in team meetings and discussions would facilitate implementation and delivery of the intervention by facilitating adaptations to fit practice. Confirming this, health visitors in focus groups pointed to the same aspects being of importance and complemented by expressing that the local representative facilitated a maintained focus on the intervention and gave peptalks when it was needed, and furthermore how the direct link between local representatives and the intervention developers would facilitate a sense of ownership because questions could be raised and quickly answered, or adaptations made continuously.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u0026ldquo;\u003cem\u003eWell, I think that the occasional peptalk... And then also that the distance isn\u0026rsquo;t that long. We have experienced that something was changed, for example: \u0026lsquo;It just doesn\u0026rsquo;t make sense to call this mother \u0026ndash; it feels stupid, because she just breastfeeds [\u0026hellip;]\u0026rsquo;. Like, she\u0026rsquo;ll (the local representative) then ask if it\u0026rsquo;s okay to just send a text message. And then that was okay. Yeah, then you kind of feel like we have influence.\u0026rdquo;\u003c/em\u003e (Health visitor 16)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eContrary, when local representatives did not provide peptalks or put the intervention on team meeting agendas, the focus on the intervention faded out.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec28\" class=\"Section3\"\u003e \u003ch2\u003e4.4.3 | The project infrastructure\u003c/h2\u003e \u003cp\u003eThe intervention\u0026rsquo;s embeddedness in a large trial was frequently discussed during dialogue meetings, as the eligibility criteria for recruiting families to the trial in general and specifically to the intensified intervention placed a double burden on health visitors, because they also had to deliver the intervention. Focus group findings confirmed this but further expanded it informing that the project infrastructure ambiguously acted as a barrier for implementation due to the confusion and frustrations it posed, and as a facilitator because it ensured focus on the intervention and helped health visitors remember, for example, to deliver intervention materials to families.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026ldquo;[\u0026hellip;] Because I think that some of my focus comes when I sit with the family and must present and tell them: \u0026lsquo;We have this breastfeeding project\u0026rsquo;, and then the postcard and the website are presented, and we talk about enrolling them and what it encompasses. Then we\u0026rsquo;re already caught up in talking about breastfeeding [\u0026hellip;]\u0026rdquo;\u003c/em\u003e (Health visitor 13)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec29\" class=\"Section3\"\u003e \u003ch2\u003e4.4.4 | The influence of mothers\u0026rsquo; context\u003c/h2\u003e \u003cp\u003eIn focus groups health visitors expressed that the mothers\u0026rsquo; context impacted the intervention. This was confirmed by mothers in interviews. For instance, family members could support or argue against the efforts involved in making breastfeeding work, or a partner could provide a due diligent push to facilitate successful breastfeeding.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026rdquo;If he hadn\u0026rsquo;t pushed me to express my milk\u0026hellip; Or not push, but support me, then I would have stopped entirely and gone with formula\u0026rdquo;\u003c/em\u003e (Mother 2)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eSimilarly, members of \u0026lsquo;mother\u0026rsquo;s groups\u0026rsquo; could support each other in breastfeeding, or conversely praise the advantages of infant formula and thereby end up creating a ripple effect. As expressed by a health visitor:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u0026ldquo;\u003cem\u003eI have also experienced the impact of the mothers\u0026rsquo; group, specifically if they have talked about their experiences with bottle feeding [\u0026hellip;]. Then when I visit, they tell me: \u0026lsquo;We have started bottle feeding\u0026rsquo;, and I have not been involvement. I then ask: \u0026lsquo;Where did you get the inspiration from?', \u0026lsquo;We heard from the mothers' group that it was really good\u0026rsquo;. So, I think that the mothers' group also has an influence on what people choose. And it also differs what kind of mothers' group you are in. Is it a group where everyone breastfeeds? Or is it a mother's group where a large proportion bottle feed? So, it is at least something that I also think we are up against.\u0026rdquo;\u003c/em\u003e (Health visitor 7)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eAnother contextual factor was parity. Parity could impede the postponement of the four-month visit, as mentioned above. Managers of intervention municipalities confirmed that the families\u0026rsquo; context could impede the postponement. Mothers expanded multiparity to act as a facilitating factor for mechanisms in instances where previous experiences provided the right prerequisites to prepare for breastfeeding and seek out as much help as possible, for example from the hospitals\u0026rsquo; antenatal care and during pregnancy visits. Conversely, repeated negative experiences with breastfeeding could cause a family to give up.\u003c/p\u003e \u003cp\u003eAdditionally, the health care context impacted the intervention. Mothers expressed that overall, the breastfeeding support provided in hospital was consistent with the support provided by the health visitors, however, they also told stories of situations in which the support counteracted the intervention, for example when health professionals handed out nipple shields to alleviate pain or instilled notions about the necessity of supplementing with formula until the milk had come in.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026rdquo; [\u0026hellip;] We were at the hospital on day two (after birth), and then a couple of nurses came in, and then she (the infant) was fed some formula, because (they said) it can take a while for your milk to come in properly.\u0026rdquo;\u003c/em\u003e (Mother 1)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eA mother\u0026rsquo;s resources, e.g., psychosocial-, educational- and mental resources, would facilitate the intervention as it enabled her to set the intention about breastfeeding and thereby receive help from her partner, cope with challenges, seek out help from others when needed and critically appraise advice and support received. All in all, having resources enabled a mother to succeed in breastfeeding. However, the intervention was designed to enhance a mother\u0026rsquo;s self-efficacy, among other things by identifying people in the social surroundings able to support with good breastfeeding accounts and to build action competence to enable the overcoming of obstacles, by for example providing knowledge and evidence-based support. Thus, when mothers with less resources were unable to overcome challenges they faced, it may point to parts of the intervention not being delivered as intended.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"5 | Discussion","content":"\u003cp\u003eThe aim of the present study was to assess the fidelity and quality of the implementation of the breastfeeding intervention and identify contextual factors in the health visitors\u0026rsquo; work potentially leading to variation in outcomes. Investigating the processes of delivery and implementation of the intervention prior to analysing the effectiveness of it was important for the authors, to remain unbiased towards the processes (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eOverall, our findings show that the intervention fidelity was high with the intervention generally being delivered as planned to the intended recipients. Exceptions were the dialogue sheet, which was not delivered consistently, and the reach of the intensified intervention, which was not consistently offered to the target group. Health visitors\u0026rsquo; reactions to and interactions with the intervention were positive. They expressed that the intervention fitted well into their usual practice, had provided a structure to, and simplified their usual breastfeeding support, and that they believed it to improve families\u0026rsquo; chances for breastfeeding, thus facilitating the implementation. Furthermore, mothers expressed having received the intervention as planned and reacted positively to the intervention materials and to the intensified intervention. Contextual factors that might have impacted the implementation and delivery of the intervention was staff- and management turnover, the project infrastructure that entailed a dual task for health visitors in delivering the intervention and recruitment to the trial, and the mothers\u0026rsquo; individual contexts that influenced the mechanisms of change.\u003c/p\u003e \u003cp\u003eVarious contextual factors existed across trial arms, suggesting that these organisational aspects may also apply beyond the participating municipalities to the wider national context of the Danish health visiting programmes. These factors play a role in the interpretation of the future effectiveness study and in deciding on potential scale-ups of the intervention.\u003c/p\u003e \u003cp\u003e First, the content of the health visiting programmes across the trial arms was found to be largely similar, meaning that parents in the control arm may have received an offer very similar in structure to the intervention. However, due to the randomised nature of the study and to the statements made by health visitors in the intervention arm about how their breastfeeding support had become simpler and more structured, we argue that the quality of the offers received across trial arms will likely have been different. Moreover, a simpler breastfeeding support may more comprehensible across different levels of health literacy and thereby holds the potential to reduce social inequality. Pregnancy visits were offered in most municipalities in both trial arms, and a higher proportion of control clusters reported having specific health visitors appointed to handle care of special groups, e.g., the target group for the intensified intervention. This suggests that a scale-up of the intervention may be easily accomplished in the Danish context. Transferability to other settings will need to take into consideration the interaction and fit between the intervention and context.\u003c/p\u003e \u003cp\u003eSecond, relationship formation between mothers and health professionals, open communication about breastfeeding goals and continuity in the support provided, have been proved as facilitating delivery of tailored and effective breastfeeding support (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). This was confirmed by the mothers in this study. Qualitative studies of breastfeeding support for vulnerable groups have found that the social network is important in supporting lactating women, and how some women choose not to consult with a health professional despite having needs (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e). Our results suggests that pregnancy visits help facilitate the intervention delivery by founding the relationship and preparing women for breastfeeding, and furthermore that the intensified intervention seemed to facilitate reaching out to health visitors. Contextual factors such as staff-turnover may have impacted on this continuity of care, however seemingly not to an extend where the intervention mechanisms were hindered. We assume that the intervention will produce effects because the pregnancy visits helped facilitate health visitors\u0026rsquo; provision of tailored support, and we recommend that the impact of proper breastfeeding preparation in pregnancy should be explored in other contexts or maintained when already existing.\u003c/p\u003e \u003cp\u003eThird, fathers/partners have been stressed as having major influence on the breastfeeding either by supporting or undermining breastfeeding (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e). Our empirical data from interviews with mothers supports this and our analysis further expands it to be catalysed by the mother\u0026rsquo;s expressed intention for breastfeeding. This finding supports the intervention\u0026rsquo;s intention that breastfeeding support should be provided to both parents for mothers to express their intention and for partners to back this intention. Future analyses of the impact of inclusion of fathers/partners in the breastfeeding support is planned in the Breastfeeding Trial and will provide a deeper understanding of the intervention mechanisms.\u003c/p\u003e \u003cp\u003eFourth, health visitors in the intervention arm reported to have discussed breastfeeding with colleagues more frequently than health visitors in the control arm, and may have facilitated the implementation, although this was not mentioned by the health visitors participating in the focus groups. According to Chesnel et al. (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e), the opportunity to discuss support practices with colleagues is an important part of breastfeeding education, but frequent discussions may, if the breastfeeding support is outdated, impede the entire teams\u0026rsquo; provision of breastfeeding support. We recently established that the training programme was effective on health visitors\u0026rsquo; self-reported self-efficacy and action competence and somewhat on knowledge (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). The health visitors in present study highlighted that having gained knowledge was one of the major benefits of the intervention. This suggests that the knowledge constructs investigated in the previous article, may have overlooked other important knowledge components. Still, some mothers had experienced support in opposition with the health visitors\u0026rsquo; training, indicating that changing practice and unlearning routines is difficult, despite being taught otherwise, also previously implied by Dykes (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). Consequently, relevant revisions of the intervention should involve ensuring collegial discussions and training should include unlearning of inappropriate and potentially outdated practices. Both factors are most likely relevant across different contexts.\u003c/p\u003e \u003cp\u003eFinally, contextual factors external to the health visiting programmes also influenced the implementation and mechanisms of the intervention. During the intervention period earmarked paternity leave was politically introduced in Denmark, leading to 11 weeks out of the 52 weeks legally dedicated parental leave for employees, being allocated to the father/partner (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e). While we do not contest the political context for the legislative introduction of paternity leave, this may have antagonised the intervention by accelerating the introduction of solid food into the infants\u0026rsquo; diet to be able to feed the infant while the mother is back at work, while the intervention sought to postpone this introduction of solid foods. In an international perspective, the Danish parental leave, although reformed, ensures good circumstances for family wellbeing (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e) and is among the most privileged globally. If in future studies we find that the intervention effect is overshadowed by the parental leave reform, the intervention might have had even lower odds in countries with poorer leave legislation.\u003c/p\u003e \u003cp\u003eTaking all these contextual aspects into consideration, we maintain that the present intervention holds the potential to improve breastfeeding rates and reduce social inequality in breastfeeding in a Danish context given the findings of this study and because it offers an approach that is highly acceptable by the health care providers and because families of lower health literacy levels may be more likely to comprehend four simple messages than an array of recommendations. Adaptation of the intervention to other contexts may require consideration of the contextual aspects found to impact the intervention mechanisms; however, simplifying breastfeeding support to focus on four simple messages based on evidence seems a low-hanging fruit with potential to implemented and tested in other settings.\u003c/p\u003e \u003cdiv id=\"Sec31\" class=\"Section2\"\u003e \u003ch2\u003e5.1 | Strengths and limitations\u003c/h2\u003e \u003cp\u003eThis process evaluation has many strengths, for instance, the variety of data sources, systematic coverage and analytical integration. Having collected data in the control clusters offers an insight into the contextual factors at play across the trial arms. Moreover, we chose to invite health visitors not already involved as local representatives to the focus groups, because we anticipated that the local representatives would be more positive about the project and breastfeeding in general than their colleagues. Nevertheless, selection bias was a risk but seemed to be low as health visitors in the focus groups expressed very different opinions towards the project.\u003c/p\u003e \u003cp\u003eThe study also holds several limitations. First, having collected data for the process evaluation prior to completing the data collection might enhance the focus on breastfeeding in the control clusters, leading to a possible contamination across trial arms. Second, the data themselves hold limitations, such as bias due to self-report, quality of data extracted from health visitor records, selection bias in both the health visitor survey and in the qualitative data collection, and in the conduct of focus groups online. The moderator\u0026rsquo;s role in online focus groups is generally perceived similar to regular focus groups, but advisably taking a more active role to maintain a steady flow of communication (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e). The online focus groups in the present study bordered on structured group interviews. Yet, the trade-off was, that all participants voiced their opinions and therefore no participants ended up generating data alone. Third, due to the multitude of data sources the analysis could only scratch the surface of mechanisms. However, future planned studies using Realist Evaluation methods aim to explore specific mechanisms of change in the intervention in more depth (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). And finally, the process evaluation may lead to potentially strengthened breastfeeding support due to the enhanced focus on the intervention. Therefore, even if conducting more investigation of the support in the control arm would have further illuminated similarities and differences across trial arms, we chose to meddle as little as possible in the control arm to decrease the risk of contamination (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e"},{"header":"6 | Conclusion","content":"\u003cp\u003eThe overall fidelity of the intervention delivery was high. Health visitors found the intervention to fit well within their practice and that using it structured and simplified their breastfeeding support. Parents were positive about the support received and the intervention material and found the proactive telephone calls in the intensified intervention to provide a sense of security. Organisational factors such as staff and management turnover acted as a barrier for the implementation. The present study offers a lens through which to view the upcoming effectiveness evaluation. Interventions aimed at enabling health care providers to deliver simplified and structured breastfeeding support like the one studied in this article, may be a means to increase breastfeeding rates and reduce social inequality in breastfeeding also in other contexts, nationally and internationally, because it offers an approach that is highly acceptable by the health care providers and potentially easier to comprehend and apply for families of lower health literacy levels.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eBMI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBody Mass Index\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIBCLC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eInternational Board Certified Lactation Consultant\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eMRC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMedical Research Counsil\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eThe study is conducted in accordance with the Declaration of Helsinki (36) and gained approval from the Research Ethics Committee at University of Copenhagen (Cno. 504-0276/21-5000). The study protocol is registered at Clinical Trials: NCT05311631 https://clinicaltrials.gov/ct2/show/NCT05311631. First posted April 5, 2022.\u003c/p\u003e\n\u003cp\u003eSelection of mothers to the intensified intervention was based solely on two criteria: young age and/or low educational attainment. The decision was not based on a needs assessment of the individual mother and her chances of obtaining a successful breastfeeding trajectory by the health visitor. This may imply that mothers of young age and/or with low educational attainment may have felt wrongfully stigmatised and placed in the \u0026lsquo;high-risk\u0026rsquo; category, despite our data disconfirming this. Conversely, the selection criteria may have caused mothers to be overlooked, who might have benefitted from the intensified intervention.\u003c/p\u003e\n\u003cp\u003eManagers of the participating health visiting programmes signed a collaboration agreement, including consent to participate in data collection. Participation in the health visitor survey was voluntary, and health visitors gave their informed consent by participating.\u0026nbsp;Informed content was collected verbally and in writing among all families and health visitors participating in interviews and focus group discussions, respectively.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e\n\u003cp\u003eQuantitative data from surveys will be available upon reasonable request. Because the qualitative data include sensitive information about informants, these data will not be available.\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eThe authors declare that they have no conflicts of interest.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eThis study was funded by NordeaFonden and Det Obelske Familiefond. The funders had no role in the data collection, data analyses or interpretations of the findings in the study.\u003c/p\u003e\n\u003ch2\u003eAuthors\u0026rsquo; contributions\u003c/h2\u003e\n\u003cp\u003eHKR, SFV, IN and KSL conceived of the study. HKR and AKG collected the data. HKR, AKG and SFV analysed the qualitative data and HKR analysed the quantitative data and conducted the convergence analysis. All authors contributed to the interpretation of study results. HKR wrote the initial manuscript draft. All authors revised the manuscript and approved the final manuscript.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eAcknowledgements\u003c/h2\u003e\n\u003cp\u003eWe wish to express our sincere gratitude to the families, the health visitors and the managers of the health visiting programmes for their willingness to participate in interviews, focus groups and surveys conducted for this study. Without their time and dedication, we would not have been able to carry out this process evaluation.\u003c/p\u003e\n\u003ch2\u003eAuthors\u0026rsquo; information\u003c/h2\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eP\u0026eacute;rez-Escamilla R, Tomori C, Hern\u0026aacute;ndez-Cordero S, Baker P, Barros AJD, B\u0026eacute;gin F, et al. Breastfeeding: crucially important, but increasingly challenged in a market-driven world. The Lancet. 2023;401(10375):472-85. [doi: 10.1016/s0140-6736(22)01932-8].\u003c/li\u003e\n\u003cli\u003eRollins NC, Bhandari N, Hajeebhoy N, Horton S, Lutter CK, Martines JC, et al. Why invest, and what it will take to improve breastfeeding practices? The Lancet. 2016;387(10017):491-504. [doi: https://doi.org/10.1016/S0140-6736(15)01044-2].\u003c/li\u003e\n\u003cli\u003eVictora CG, Bahl R, Barros AJ, Fran\u0026ccedil;a GV, Horton S, Krasevec J, et al. 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Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345(sep04 1):e5661-e. [doi: 10.1136/bmj.e5661].\u003c/li\u003e\n\u003cli\u003eO\u0026rsquo;Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Academic medicine. 2014;89(9):1245-51.\u003c/li\u003e\n\u003cli\u003ehttps://www.sas.com/en_gb/home.html: SAS Analytics; 2023. Accessed: August 14 2023.\u003c/li\u003e\n\u003cli\u003eMalterud K. Systematic text condensation: A strategy for qualitative analysis. Scandinavian Journal of Public Health. 2012;40(8):795-805. [doi: 10.1177/1403494812465030].\u003c/li\u003e\n\u003cli\u003eLumivero. NVivo software for qualitative analysis.\u003c/li\u003e\n\u003cli\u003eHomer CS, Leap N, Edwards N, Sandall J. Midwifery continuity of carer in an area of high socio-economic disadvantage in London: A retrospective analysis of Albany Midwifery Practice outcomes using routine data (1997-2009). Midwifery. 2017;48:1-10. [doi: 10.1016/j.midw.2017.02.009].\u003c/li\u003e\n\u003cli\u003ePrussing E, Browne G, Dowse E, Hartz D, Cummins A. Implementing midwifery continuity of care models in regional Australia: A constructivist grounded theory study. Women and Birth. 2023;36(1):99-107. [doi: https://doi.org/10.1016/j.wombi.2022.03.006].\u003c/li\u003e\n\u003cli\u003eFrederiksen MS, Schmied V, Overgaard C. Supportive encounters during pregnancy and the postnatal period: An ethnographic study of care experiences of parents in a vulnerable position. Journal of Clinical Nursing. 2021;30(15-16):2386-98. [doi: 10.1111/jocn.15778].\u003c/li\u003e\n\u003cli\u003eOgbo F, Akombi B, Ahmed K, Rwabilimbo A, Ogbo A, Uwaibi N, et al. Breastfeeding in the Community\u0026mdash;How Can Partners/Fathers Help? A Systematic Review. International Journal of Environmental Research and Public Health. 2020;17(2):413. [doi: 10.3390/ijerph17020413].\u003c/li\u003e\n\u003cli\u003eChesnel MJ, Healy M, McNeill J. Experiences that influence how trained providers support women with breastfeeding: A systematic review of qualitative evidence. PLoS One. 2022;17(10):e0275608. [doi: 10.1371/journal.pone.0275608].\u003c/li\u003e\n\u003cli\u003eDykes F. The education of health practitioners supporting breastfeeding women: time for critical reflection. Maternal and Child Nutrition. 2006;2(4):204-16. [doi: 10.1111/j.1740-8709.2006.00071.x].\u003c/li\u003e\n\u003cli\u003eThe Ministry of Employment [Besk\u0026aelig;ftigelsesministeriet]. Leave rules - for children born from 2 August 2022 [Orlovsregler - for b\u0026oslash;rn f\u0026oslash;dt fra 2. august 2022] 2022 [Available from: https://bm.dk/arbejdsomraader/aktuelle-fokusomraader/orlovsregler-for-boern-foedt-fra-2-august-2022/]. Accessed: 12 December 2023.\u003c/li\u003e\n\u003cli\u003eHoumark MA, L\u0026oslash;chte J\u0026oslash;rgensen CM, Kristiansen IL, Gensowski M. Effects of Extending Paid Parental Leave on Children\u0026rsquo;s Socio-Emotional Skills and Well-Being in Adolescence. Univ of Copenhagen Dept of Economics Discussion Paper, CEBI Working Paper. 2022;14:22.\u003c/li\u003e\n\u003cli\u003eSchulze L, Trenz M, Cai Z, Tan C-W. Conducting online focus groups-practical advice for information systems researchers. Communications of the Association for Information Systems. 2023;52(1):20.\u003c/li\u003e\n\u003cli\u003eFrench C, Dowrick A, Fudge N, Pinnock H, Taylor SJC. What do we want to get out of this? a critical interpretive synthesis of the value of process evaluations, with a practical planning framework. BMC Medical Research Methodology. 2022;22(1). [doi: 10.1186/s12874-022-01767-7].\u003c/li\u003e\n\u003cli\u003eWorld Medical Association Declaration of Helsinki. JAMA. 2013;310(20):2191. [doi: 10.1001/jama.2013.281053].\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cdiv\u003e\n \u003ctable border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 1\u003c/div\u003e\n \u003cdiv\u003e\n \u003cdiv\u003eOverview of data sources for the process evaluation and the research questions they inform\u003c/div\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv\u003eData source\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv\u003eProcess evaluation theme and the related key functions\u003c/div\u003e\n \u003cdiv\u003e(Moore et al. 2015)\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv\u003eResearch questions answered by data\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"4\"\u003e\n \u003cdiv\u003eORGANISATIONAL SURVEY\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eImplementation\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eDose\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did the families in the intervention clusters receive the postponed introduction to solid food\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eContext\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eContextual factors that shape the implementation and how the intervention works\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did the intervention clusters have equal opportunity to deliver breastfeeding support as the control clusters?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; What were the most important structural, physical, cultural, social and individual barriers and facilitators for the intervention?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; Did the intervention clusters have important contextual factors that could impede or facilitate the implementation or delivery of the intervention?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; If so, was this the case for control clusters as well?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"9\"\u003e\n \u003cdiv\u003eHEALTH VISITOR SURVEY\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eImplementation\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eDose\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; What did the health visitors report having delivered?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eReach\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did health visitors offer the intended intervention to families in each target group? If not, why?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eAdaptation\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; How did the intervention unfold in practice?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eMechanisms of impact\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eReactions and interactions with the intervention\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; How did the health visitors respond to the intervention?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eUnexpected pathways and consequences\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did the intervention produce unanticipated effects or negative consequences?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eContext\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eContextual factors that shape the implementation and how the intervention works\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did health visitors participate in the training?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; Was there contamination due to flux of staff across trial arms?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; Did health visitors have managerial support for delivering the intervention?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; Did health visitors have time to familiarise themselves with the intervention?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cdiv\u003eHEALTH VISITOR RECORDS\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eImplementation\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eDose\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; How many visits and telephone calls families have received?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; Did families in intervention clusters receive more visits and telephone calls than families in control clusters?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cdiv\u003eWEBSITE DATA\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eMechanisms of impact\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eReactions and interactions with the intervention\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; How did the families respond to the intervention?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"8\"\u003e\n \u003cdiv\u003eDIALOGUE MEETINGS\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eImplementation\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eDose\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Were there implementation issues regarding delivery of certain elements?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eAdaptation\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; What adaptations have been made to the intervention? And why?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eMechanisms of impact\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eReactions and interactions with the intervention\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; How did the health visitors and the families respond to the intervention?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eUnexpected pathways and consequences\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did the intervention produce unanticipated effects or negative consequences?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eContext\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eContextual factors that shape the implementation and how the intervention works\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; What were the most important cultural, social and individual barriers and facilitators for the intervention?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; What contextual factors affected (or was affected by) implementation, intervention mechanisms and outcomes?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"10\"\u003e\n \u003cdiv\u003eFOCUS GROUPS WITH HEALTH VISITORS\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eImplementation\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eDose\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; What did the health visitors express having delivered?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eReach\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did health visitors offer the intended intervention to families in each target group? If not, why?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eAdaptation\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; How did the intervention unfold in practice?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eMechanisms of impact\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eReactions and interactions with the intervention\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; How did the health visitors and the families respond to the intervention?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eMediators\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did the intervention work as planned?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; Were the planned mechanisms of impact activated or did unforeseen mechanisms of impact occur?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eUnexpected pathways and consequences\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did the intervention produce unanticipated effects or negative consequences?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eContext\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eContextual factors that shape the implementation and how the intervention works\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; What were the most important structural, physical, cultural, social and individual barriers and facilitators for the intervention?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; What contextual factors affected (or was affected by) implementation, intervention mechanisms and outcomes?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; Was there causal mechanisms present in the context that acted to sustain the status quo or potentiate effects?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"9\"\u003e\n \u003cdiv\u003eINTERVIEWS WITH FAMILIES\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eImplementation\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eDose\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; What did the families report having received?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eReach\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did families in the target group for the intensified intervention receive the proactive telephone calls? If not, why?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eMechanisms of impact\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eReactions and interactions with the intervention\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; How did the end-users (families) respond to the intervention?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; Which impact did the intervention seem to have?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eMediators\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did the intervention work as planned?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; Were the planned mechanisms of impact activated or did unforeseen mechanisms of impact occur?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eUnexpected pathways and consequences\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; Did the intervention produce unanticipated effects or negative consequences?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eContext\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eContextual factors that shape the implementation and how the intervention works\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u0026bull; What were the most important cultural, social and individual barriers and facilitators for the intervention?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; What contextual factors affected (or was affected by) intervention mechanisms and outcomes?\u003c/div\u003e\n \u003cdiv\u003e\u0026bull; Were there causal mechanisms present in the context that acted to sustain the status quo or potentiate effects?\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv\u003e\n \u003ctable border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 2\u003c/div\u003e\n \u003cdiv\u003e\n \u003cdiv\u003eOrganisational contextual factors reported cross-s\u003cbr\u003eectionally in March 2023, distributed on trial arms\u003c/div\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv\u003eControl clusters (n\u0026thinsp;=\u0026thinsp;10)\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv\u003eIntervention clusters (n\u0026thinsp;=\u0026thinsp;10)\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eMean (range)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eMean (range)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u003cspan type=\"Italic\" name=\"Emphasis\"\u003ep\u003c/span\u003e-value*\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eNumber of newborns in 2021\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e627 (195\u0026ndash;2390)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e570 (348\u0026ndash;1229)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.724\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eNumber of newborns in 2022\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e582 (138\u0026ndash;2200)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e518 (310\u0026ndash;1150)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.579\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eShift in management since project start in 2021, n (%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e3 (30)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e5 (50)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.240\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eNumber of health visitors employed, median (IQR)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e15 (12\u0026ndash;17)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e13 (10\u0026ndash;18)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.868\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eProportion of staff turnover during 2022, %\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e12 (0-28.6)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e18 (0\u0026ndash;50)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.355\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eNumber of IBCLCs employed, median (IQR)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e2 (1\u0026ndash;2)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e2 (1\u0026ndash;3)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.653\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eProportion reporting appointed specific health visitors handling the care of special groups, for instance young mothers, n (%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e7 (70)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e4 (40)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.150\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eFrequency of team meetings, n (%)\u003c/div\u003e\n \u003cdiv\u003eWeekly\u003c/div\u003e\n \u003cdiv\u003eBiweekly\u003c/div\u003e\n \u003cdiv\u003eMonthly\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e3 (30)\u003c/div\u003e\n \u003cdiv\u003e4 (40)\u003c/div\u003e\n \u003cdiv\u003e3 (30)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e4 (40)\u003c/div\u003e\n \u003cdiv\u003e1 (10)\u003c/div\u003e\n \u003cdiv\u003e5 (50)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.053\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eProportion of municipalities offering pregnancy visits, n (%)\u003c/div\u003e\n \u003cdiv\u003eFor primiparous families\u003c/div\u003e\n \u003cdiv\u003eFor multiparous families\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e8 (80)\u003c/div\u003e\n \u003cdiv\u003e6 (60)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e9 (90)\u003c/div\u003e\n \u003cdiv\u003e8 (80)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.395\u003c/div\u003e\n \u003cdiv\u003e0.244\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eTime allocated to pregnancy visits, minutes\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e78 (60\u0026ndash;115)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e80 (60\u0026ndash;120)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.977\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eTime allocated to first visit after birth, minutes\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e53 (30\u0026ndash;90)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e62 (30\u0026ndash;90)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.533\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eEstimated proportion of families in need of extra needs-based visits, %\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e36 (20\u0026ndash;63)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e29 (0\u0026ndash;50)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.512\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eEstimated proportion of families declining the health visiting programme in 2022, %\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e1 (0\u0026ndash;5)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e1 (0\u0026ndash;2)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0.873\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv class=\"gridtable\"\u003e\n \u003cp\u003eAbbreviations: IBCLC, International Board Certified Lactation Consultant; IQR, Interquartile Range\u003c/p\u003e\n \u003cp\u003e*P-values are calculated using Wilcoxon rank sum test for categorical data and skewed continuous data, Fisher\u0026rsquo;s exact test for frequencies and \u003cem\u003et\u003c/em\u003e-test for normally distributed continuous data.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"gridtable\"\u003e\u003cstrong\u003eTable 3 |\u003c/strong\u003e Mean contacts per birth before and after implementation of the intervention across trial arms\u003ctable id=\"Tabc\" border=\"1\"\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePregnancy visits\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNumber of visits\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNeeds-based visits\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eTelephone contacts\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eIntervention clusters\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBefore\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAfter\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBefore\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAfter\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBefore\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAfter\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBefore\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAfter\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.5 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7.5 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.9\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.5 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.1 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003en/a\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003en/a\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e15.1*\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e19.5*\u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e---\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e---\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.7 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.1 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5.6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.9 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.2 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003en/a\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.5 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.3 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.0\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.2 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.5 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.8 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.3 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5.3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5.7 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003en/a\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003en/a\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.9 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.6 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5.1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5.4 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.2 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.0\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.7 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.9 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.0\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7.0 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.9 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.0\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4.6 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 8\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.6 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e8.9\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7.7 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.0 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.8\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.8\u003csup\u003e\u0026rarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 9\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.0\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.8 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.5 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.6 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.9\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4.1 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 10\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.1\u003csup\u003e\u0026rarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7.1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.3 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.6 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5.3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4.9 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eControl clusters\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBefore\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAfter\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBefore\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAfter\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBefore\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAfter\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBefore\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAfter\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 11\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.8\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.8\u003csup\u003e\u0026rarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e8.0\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.6 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.0\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.6 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.4 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 12\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.3 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.8 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.4\u003csup\u003e\u0026rarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.7 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 13\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.5 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7.3 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.6 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.0 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 14\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.9 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5.7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.3 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.0 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.4 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 15\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.4 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.1 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.0\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.6 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.3 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 16\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.9 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5.6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5.8 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.5 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4.1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.9 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 17\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.9 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.2 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.3 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.0 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 18\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.6\u003csup\u003e\u0026rarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.9 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.2 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.3 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 19\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.5\u003csup\u003e\u0026rarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6.9\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7.0 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.7 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3.6 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCluster 20\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.7 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4.9\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5.3 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1.6 \u003csup\u003e\u0026uarr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0.4 \u003csup\u003e\u0026darr;\u003c/sup\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003ePeriods: \u003cem\u003eBefore\u003c/em\u003e = October 2021 \u0026ndash; March 2022; \u003cem\u003eAfter\u003c/em\u003e = August 2022 \u0026ndash; July 2023; \u003cem\u003eIntermediate\u003c/em\u003e = April 2022 \u0026ndash; July 2022. The intermediate period is not reported to allow for an implementation period in the intervention clusters. The intervention clusters underwent training during March 2022 and began implementation the with implementation following completion of the training.\u003c/p\u003e\n\u003cp\u003e*The specific electronic record system did not support extraction based on infants aged 0-6 months. Thus, numbers reported are higher than the remaining municipalities.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eArrow pointing down indicates a drop, arrow pointing right indicates no change, while arrow pointing down indicates an increase in mean contact over time periods.\u003c/p\u003e\n\u003cp\u003eSource: Health visitor records\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab4\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eTen most popular webpages on the intervention website June 2022 - June 2023\u003c/div\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eWebpage\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eTotal visits in period\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBreastfeeding positions (video)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e32830\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSigns of thriving - the child\u0026apos;s signs of hunger and satiety (video)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e22838\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eLaid-back breastfeeding (video)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e11322\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eGood suckling technique (video)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6775\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSkin-to-skin principle to start over again with breastfeeding (video)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6681\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBreastfeeding with nipple shield (video)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5029\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePreparation for breastfeeding (video)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3671\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eHand expression of breastmilk (video)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1283\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBreastfeeding during the first period (video)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e884\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eHow breastfeeding works (physiological explanation) (video)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e676\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv class=\"gridtable\"\u003e\n \u003cdiv align=\"left\" class=\"colspec\"\u003e\u003cbr\u003e\u003c/div\u003e\n\u003c/div\u003e\n\u003ctable border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 5\u003c/div\u003e\n \u003cdiv\u003e\n \u003cdiv\u003eComparison of contextual elements reported by health visitors at follow-up. Both trial arms.\u003c/div\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv\u003eControl group\u003c/div\u003e\n \u003cdiv\u003en\u0026thinsp;=\u0026thinsp;150\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv\u003eIntervention group\u003c/div\u003e\n \u003cdiv\u003en\u0026thinsp;=\u0026thinsp;134\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" style=\"width: 13.5937%;\"\u003e\n \u003cdiv\u003eComparison\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv\u003en (%)\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv\u003en (%)\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" style=\"width: 13.5937%;\"\u003e\n \u003cdiv\u003e\u003cspan type=\"Italic\" name=\"Emphasis\"\u003ep\u003c/span\u003e-value*\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u003cspan type=\"Bold\" name=\"Emphasis\"\u003eHow often did you discuss questions regarding breastfeeding with your colleagues during the past month?\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"char\" style=\"width: 13.5937%;\"\u003e\n \u003cdiv\u003e0.009\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eOnce or several times a week\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e60 (40)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e64 (48)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 13.5937%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e1\u0026ndash;3 times during the last month\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e80 (54)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e64 (48)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 13.5937%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eI have not discussed questions about breastfeeding during the last month\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e9 (6)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e6 (5)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 13.5937%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u003cspan type=\"Bold\" name=\"Emphasis\"\u003eHave you provided more or less needs-based visits than usual related to breastfeeding during the last six months?\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"char\" style=\"width: 13.5937%;\"\u003e\n \u003cdiv\u003e0.001\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eMore\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e25 (17)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e42 (31)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 13.5937%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eThe same\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e116 (77)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e76 (57)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 13.5937%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eLess\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e0 (0)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e1 (1)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 13.5937%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003eNot sure\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e9 (6)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e15 (11)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 13.5937%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv\u003e\u003csup\u003e*\u003c/sup\u003e P-values calculated using Fisher\u0026rsquo;s exact test\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 1.25%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 13.5937%;\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"international-journal-for-equity-in-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ijeh","sideBox":"Learn more about [International Journal for Equity in Health](http://equityhealthj.biomedcentral.com)","snPcode":"12939","submissionUrl":"https://submission.nature.com/new-submission/12939/3","title":"International Journal for Equity in Health","twitterHandle":"@equityhealthj","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"complex interventions, process evaluation, cluster-randomised trial, implementation, breastfeeding, health visiting, infant health, socioeconomic factors, delivery of health care, public health","lastPublishedDoi":"10.21203/rs.3.rs-3816186/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3816186/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eBreastfeeding is a powerful public health intervention that produce long-term health benefits. Still, in high-income countries such as Denmark, breastfeeding rates are suboptimal and distributed unequally across socio-economic positions. The \u0026lsquo;Breastfeeding \u0026ndash; a good start together\u0026rsquo; intervention to promote longer duration of and reduce social inequality in exclusive breastfeeding, was rolled out in a cluster-randomised trial during 2022\u0026ndash;2023 in a sample of 21 municipalities in two Danish regions. A process evaluation was conducted to assess the fidelity and quality of the implementation and identify possible contextual factors that might have impacted the proposed mechanisms of change.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003e The Medical Research Counsel framework for conducting process evaluations guided the study, which was conducted using mixed-methods in a convergence design. Quantitative data: contextual mapping survey (n\u0026thinsp;=\u0026thinsp;20), health visitor survey (n\u0026thinsp;=\u0026thinsp;284), health visitor records from 20 clusters and intervention website statistics. Qualitative data: dialogue meetings (n\u0026thinsp;=\u0026thinsp;7), focus groups (n\u0026thinsp;=\u0026thinsp;3) and interviews (n\u0026thinsp;=\u0026thinsp;8).\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eOverall, the intervention was delivered as planned to intended recipients, with few exceptions. Health visitors reacted positively to the intervention, which they expressed fitted well within their usual practice and which they believed to enhance families\u0026rsquo; chances for breastfeeding. Mothers expressed having received the intervention, with few exceptions, and reacted positively to the intervention. Health visitors worried about stigmatisation of the mothers receiving the intensified intervention, however none of the interviewed mothers had felt stigmatised. Contextual factors impacting the intervention implementation and mechanisms were staff- and management turnover, project infrastructure and mothers\u0026rsquo; context, including resources, social network and previous experiences.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThe overall fidelity of the intervention delivery was high. Health visitors and families responded well to the intervention. Interventions aimed at enabling health care providers to deliver simplified and structured breastfeeding support, in accordance with the support in other sectors of the health care system, may be a means to increase breastfeeding rates and reduce social inequality in breastfeeding, also in international contexts.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003eClinical Trials: NCT05311631. First posted April 5, 2022.\u003c/p\u003e","manuscriptTitle":"Implementation of a community-based breastfeeding support intervention to prolong duration of and reduce social inequality in exclusive breastfeeding: a mixed-methods systematic process evaluation in a cluster-randomised trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-01-02 04:47:55","doi":"10.21203/rs.3.rs-3816186/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-08-21T12:14:08+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-05-07T03:35:59+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"8bc1ba97-9dad-4035-89ca-7315dec109f8_SNPRID","date":"2024-04-15T15:38:08+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"23881fae-beed-4331-b79f-934ee4bf5ac0","date":"2024-01-14T19:54:36+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"f5809360-d01a-4864-846f-1ef68fb16da0","date":"2024-01-12T16:05:07+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-01-11T21:56:28+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2023-12-29T17:39:09+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2023-12-29T13:46:04+00:00","index":"","fulltext":""},{"type":"submitted","content":"International Journal for Equity in Health","date":"2023-12-28T10:14:46+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"international-journal-for-equity-in-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ijeh","sideBox":"Learn more about [International Journal for Equity in Health](http://equityhealthj.biomedcentral.com)","snPcode":"12939","submissionUrl":"https://submission.nature.com/new-submission/12939/3","title":"International Journal for Equity in Health","twitterHandle":"@equityhealthj","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"2d19e6df-26ba-4cc1-a8ae-affcb127d319","owner":[],"postedDate":"January 2nd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-10-14T16:03:44+00:00","versionOfRecord":{"articleIdentity":"rs-3816186","link":"https://doi.org/10.1186/s12939-024-02295-0","journal":{"identity":"international-journal-for-equity-in-health","isVorOnly":false,"title":"International Journal for Equity in Health"},"publishedOn":"2024-10-08 15:58:06","publishedOnDateReadable":"October 8th, 2024"},"versionCreatedAt":"2024-01-02 04:47:55","video":"","vorDoi":"10.1186/s12939-024-02295-0","vorDoiUrl":"https://doi.org/10.1186/s12939-024-02295-0","workflowStages":[]},"version":"v1","identity":"rs-3816186","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3816186","identity":"rs-3816186","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}