Development of a complex intervention to strengthen municipality-based breastfeeding support to reduced social inequity in breastfeeding

Development of a complex intervention to strengthen municipality-based breastfeeding support to reduced social inequity in breastfeeding | 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 Development of a complex intervention to strengthen municipality-based breastfeeding support to reduced social inequity in breastfeeding Ingrid Nilsson, Marianne Busck-Rasmussen, Sarah Fredsted Villadsen This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4662366/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 02 Oct, 2024 Read the published version in Archives of Public Health → Version 1 posted 12 You are reading this latest preprint version Abstract Background Breastfeeding is the ideal nutrition for infants and protects infants and mothers from a range of adverse health outcomes during their lifespan. In Denmark, while the breastfeeding initiation rate is high, only 14% of mothers meet the World Health Organization’s recommendation of exclusive breastfeeding at six months. Furthermore, a notable social inequity exists among those who achieve this recommendation. Knowledge of effective interventions to reduce breastfeeding inequity is limited. A previous hospital-based intervention succeeded in increasing breastfeeding duration. However, most breastfeeding support is provided in Danish municipalities by health visitors. This called for adapting the intervention to the health visiting program and developing an intensified intervention addressing the social inequity in breastfeeding. This article describes the adaptation and development process of the intervention ‘Breastfeeding – a good start together’. Methods During a 15-month period in 2020-21, the municipal intervention was iteratively developed using a three-stage framework for developing complex health interventions described by Hawkins et al. The three stages were 1) need assessment and stakeholder consultation, 2) co-production and 3) prototyping. The process was inspired by O’Cathain et al.’s principles for a user-centred, co-created and theory- and evidence-based approach, involving parents and health visitors. Results In stage 1, we identified the needs and priorities of the target groups of the intervention. In stage 2, the intervention was developed through action research design and inspired by Duus’ ‘learning cycles’ as the method to enhance motivation and ownership and to strengthen the implementation process by creating a joint room for learning and reflection with health visitors and developers. In stage 3, the intervention was tested for feasibility and usefulness during a 2.5-month period accompanied by monthly dialogue meetings with health visitors and developers. In this period, the intervention was refined based on the gathered experiences and was subsequently prepared for evaluation. Conclusion The description of the development of this complex intervention, aimed at increasing breastfeeding duration and reducing inequity, offers breastfeeding practitioners and researchers a transparent foundation for continuously improving breastfeeding support and a methodology for complex intervention development. Trial registration Registered at Clinical Trials NCT05311631. Breastfeeding complex intervention development municipality inequity co-production action research health visitor young mothers social inequality Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Contributions to the literature There are considerable differences in breastfeeding duration due to social inequityg We lack knowledge on effective complex interventions to reduce breastfeeding inequity Prior research encourages transparency into the development process of complex public health interventions This research provides insights into a co-creation process, where a breastfeeding intervention to reduce social inequity was developed This research facilitates the ongoing qualification of breastfeeding support for the benefit of new parents and their infant. Background Exclusive breastfeeding is recognized by the World Health Organization (WHO) as the ideal nutrition globally for infants in their first six months of life, with continued breastfeeding recommended until the child reaches two years of age or beyond ( 1 ). A meta-analysis shows that the positive effects of breastfeeding benefit both mother and child during a lifespan ( 2 ). However, globally less than half of all infants are breastfed as recommended ( 3 ). In Denmark, where more than 97% of all mothers initiate breastfeeding ( 4 ), 86% and 61% of infants are fully breastfed at the age of two weeks and four months, respectively ( 5 ). In high-income countries, socio-demographic factors such as young age and low socio-economic position (SEP) can lead to early breastfeeding cessation ( 2 , 6 , 7 ). In Denmark, for instance, only 37% of mothers under 20 years and 39–50% with a short-term vocational education breastfeed for four months (Johansen et al., 2016). This highlights the need for action (Bærug et al., 2017). Addressing breastfeeding among mothers with a low SEP has been associated with increased odds of the child’s upward social mobility ( 9 ). Breastfeeding may therefore also have social benefits (Victora et al., 2015). Research shows insights into effective components of breastfeeding support for mothers at high risk of early breastfeeding cessation. The prognostic effect of education on the duration of exclusive breastfeeding seems to disappear when adjusting for psychosocial factors such as breastfeeding self-efficacy and sense of security ( 11 ). This indicates that a strengthening of these psychological factors may diminish social inequity in breastfeeding duration. A Cochrane review found that mothers at risk of early breastfeeding termination need more support from health professionals to obtain their own breastfeeding goals ( 12 ). Thus, women in this group may need strengthened feedback and recognition of their efforts, which contribute to increasing their self-efficacy ( 13 – 17 ). Despite insights from these basic research studies, to our knowledge, the number of comprehensive breastfeeding intervention studies targeting social inequity in breastfeeding is limited. From the general population, we know that interventions based on breastfeeding self-efficacy and evidence-based breastfeeding support can improve breastfeeding rates ( 18 , 19 ). Thus, a need exists for the development of a complex intervention to reduce social inequity in breastfeeding. As improved breastfeeding support is a multifaceted intervention that operates across various structural layers, engaging multiple healthcare sectors, providers and families within their respective societal, local, and familial contexts, it can be defined as a complex intervention ( 20 ). To inform the development phase of public health interventions, Hawkins et al. developed a three-stage framework consisting of 1) evidence review and stakeholder consultation, 2) co-production and 3) prototyping ( 21 ). Furthermore, O’Cathain et al. point to five key working principles, which are described as dynamic, iterative, creative, open to change and looking towards evaluation, and ten key actions (plan the process, involve stakeholders, bring together a team, review published literature, draw on existing theories, articulate program theory, undertake primary data collection, understand context, pay attention to future implementation, design and refine) for development of complex interventions ( 22 ). Importantly, they encourage the publication of the development process to enable others to understand the challenges inherent in intervention development, to promote transparency about the choices made and to facilitate reflection on the link between intervention development and evaluation results ( 22 ). An intervention, ‘Breastfeeding – a good start together’, aiming to reduce social inequity through breastfeeding support has been developed in Denmark. The intervention builds on a previous intervention for all families from 2013-14 in Denmark. In this intervention, Nilsson et al. developed and implemented a hospital-based breastfeeding support intervention (HBI), see Supplementary Table 1 for further intervention description ( 19 ). The HBI trial analysis documented increased exclusive breastfeeding at six months and reduced infant readmissions within the first week of life in mother-infant dyads. However, breastfeeding self-efficacy was not affected ( 19 ). Subsequently, health visitors in the municipalities have requested an intervention for breastfeeding support following discharge that is aligned with the HBI. Methods Aim The aim of this study is to present a systematic report of the adaptation and development phase of the intervention: ‘Breastfeeding – a good start together’. Its overall purpose was to adapt the HBI to a municipality setting (hereafter the basic intervention) and add a newly developed intensified intervention for mothers with sociodemographic vulnerability (young age and low educational attainment) (hereafter intensified intervention) (Fig. 1). The intervention was implemented in Denmark using a cluster-trial design. Elaboration of the evaluation design can be found elsewhere ( 23 ). Target groups and setting The new municipality-based breastfeeding intervention (MBI) had two target groups: the group receiving and the group delivering the intervention. The recipients were all new mothers and their partners. A specific subgroup of mothers, characterised by being under 25 years of age and/or having low educational attainment, would receive an intensified intervention as these sociodemographic aspects are associated with an increased risk of early breastfeeding cessation. Health visitors in the municipalities were the group that delivered the intervention. The adaptation and development study took place from August 2020 until December 2021 in 10 intervention municipalities in two Danish regions. These municipalities had a high frequency of mothers matching our target group, and breastfeeding rates were among the lowest in Denmark. Several of these municipalities had a high frequency of English-speaking inhabitants. In Denmark, families are offered breastfeeding support at the maternity ward after giving birth. After discharge, a universal, tax-financed, municipality-based health visiting program provides support in the families’ homes ( 24 ). Given the short duration of hospitalisation after birth, the health visitors provide most of the breastfeeding support. About 97% of all new parents participate in the health visiting program. Danish health visitors are nurses with a minimum of three years of full-time clinical experience and subsequently 1.5 years of training. Method The overall framework used during the development of the MBI was the UK’s Medical Research Council (MRC) guidance for developing and evaluating complex interventions ( 25 ) and later accompanying guidance supplements ( 26 ). The more practical processes in the developmental phase were informed by Hawkins et al.’s three-stage framework for the development of public health interventions ( 21 ) and O’Cathain’s five key working principles and ten key actions for development ( 22 ). A model of the method used is shown in Fig. 2. The reporting follows the GUIDED, a guideline for reporting intervention development studies in health research ( 27 ). The research group was divided into two: one primarily responsible for the development phase (hereafter the developers) one, for the evaluation phase (hereafter the evaluators). The following describes the methods used during the three stages of development; however, the actual process had an iterative nature. Stage 1: Evidence review and stakeholder consultation The MBI emerged from the evidence and experience of the HBI. To align the MBI with the HBI, the adaption process focused on tailoring it to the municipal setting and families’ needs from week one after birth. Consequently, the essential elements of the new program were grounded in the four core evidence-based principles of the HBI: skin-to-skin contact, frequent breastfeeding, proper positioning and joint parenting tasks including theory-based communication. This part leaned on Bandura’s theory on self-efficacy ( 28 ) and Kreuter’s theory of tailoring ( 29 ). The intervention used the same overall strategies, training of healthcare professionals and educational material, to improve breastfeeding support. Furthermore, as the aim was to address social inequity in breastfeeding, the first step sought to build an understanding of the needs of young mothers and mothers with low educational attainment, and their partners’ needs, to develop an intensified intervention component to meet their specific breastfeeding support needs. To get an overview of existing literature, we used Green et al.’s framework for narrative reviews ( 30 ) to identify existing literature about experiences of being a mother and breastfeeding, effective breastfeeding interventions and the role of self-efficacy among young mothers and mothers with short education. The review included peer-reviewed publications in English and Nordic languages from 2000 to September 2020. Additionally, contemporary national reports and unpublished academic theses were also incorporated in the report ( 31 ). Search terms included combinations of the words breastfeeding, clinical trials, maternal educational achievement, and maternal age. Searches were made in PubMed and Cinahl. To further understand the need for an intervention, several qualitative methods were employed: individual interviews with mothers and fathers in the families’ homes, observations of health visitors’ home visits and observations of mother support groups offered by the municipality and led by health visitors. Inclusion was based on maternal age and length of education as defined earlier, whereas the fathers were the ones living with the included mothers and were therefore not covered by the maternal inclusion criteria. Finally, to include the health professionals’ perspectives, focus group interviews with health visitors were performed. All interviews and observations were led by semi-structured guides. Audio recordings of the individual and focus group interviews were transcribed verbatim and analysed along with field notes from the observations using Malterud’s four-step systematic text condensation ( 32 ) and led by the study question “How do mothers of young age and short educational attainment and their partners experience breastfeeding and breastfeeding support and what has been supportive or challenging”. For more details on the method and analysis, see elsewhere ( 16 ). Stage 2: Co-production In order to ensure a needs-based intervention, to qualify the interaction between theory and practice and to support the implementation process, we used a combined user-centred, co-creation and theory- and evidence-based approach ( 22 ). In the co-creation process, we wanted to enhance motivation and ownership and strengthen the implementation process by creating room for learning and reflection with health visitors and developers. The parents were involved through the interaction with health visitors. A working group was formed consisting of two intervention developers from the National Competence Centre for Breastfeeding (IN and MBR) and one or two health visitors from each intervention municipality. Health visitors were appointed by the manager of the health visiting program in each municipality on the basis of being certified as international lactation consultants (IBCLC) or having a say in the local group of health visitors. A total of 13 health visitors from the 11 intervention municipalities and two developers were part of the working group, of which 11 were IBCLC. The health visitors were reimbursed for the time used for the project. The method ‘learning cycles’ was used. Inspired by Duus et al., researchers and health professionals met and worked together to develop new knowledge for practice ( 33 ). A core element of the co-production process was the learning cycle meetings (LCM) ( 33 ). At these meetings, the working group met for five 6-hour meetings during the development phase to discuss, propose and test ideas generated in stage 1, and give feedback on the agreed homework in between meetings. Homework included pilot-testing of intervention elements in the families for feasibility and discussion of the usefulness and practical adaptability of the elements with their local colleagues. We initiated the development in the first LCM by presenting results from stage 1 and subsequently performing a future workshop ( 34 ) to stimulate ideas for the optimal breastfeeding intervention. In the municipalities, as breastfeeding support takes place for a longer period of time than in hospitals, the four key messages had to be adapted to include relevant information and address challenges that matched the recommended period for exclusive and partial breastfeeding. Literature was consulted to support the decision-making, and external resource persons were involved when needed. During LCM, the intervention contents and materials were developed and tested in a back-and-forth process according to the key principles outlined by O’Cathain. This process continued until the group was satisfied with the products ( 22 ). During these meetings, researchers also had the opportunity to get important information about the context in which the MBI should be implemented ( 22 ). Details about the process and content of LCM are found in Fig. 3. Concurrently with the co-production of the intervention, the developers and evaluators developed a program theory ( 22 ) and the evaluators communicated with the health visitors in the working group to ensure an optimal recruitment of trial participants and data collection. Hence, health visitors in the working group acted as important links between the health visitors in each municipality and the developers, along with evaluators, to qualify the processes throughout the entire project as also recommended by MRC ( 22 , 26 ). To support the project and the working group during development, implementation and evaluation and ensure broad expertise and competence in decision-making, a reference group was established, representing managers of the health visiting programs in the participating municipalities, representatives from relevant professional associations and representatives from the National Health Authority, the national association of municipalities and Danish Regions, which are responsible for hospitals in Denmark. The reference group met twice a year during the entire project. Stage 3: Prototyping A website for parents was tested for functionality by an IT expert and a research colleague; its content and usefulness by parent couples. A theoretical manual of breastfeeding knowledge and intervention activities for health visitors was reviewed by two experts in breastfeeding. The coherent intervention was tested for feasibility in a 2.5-month implementation period in the municipalities after health visitors had received training. The implementation was substantiated by dialogue meetings among the health visitors from the working group and facilitated by the developers. The program theory was finalised to inform the evaluation. Results The following are the outcomes from the three stages of the development and implementation processes. Stage 1: Evidence review and stakeholder consultation Narrative review The unpublished narrative review included 32 publications, a report from the Danish National Institute of Public Health and a master thesis from the University of Copenhagen ( 31 ). Most of the studies reported on young mothers, only a few on mothers with no or low educational attainment. For understanding this group of mothers’ experiences of the transition to motherhood, we found six qualitative peer-reviewed studies ( 13 , 17 , 35 – 38 ) and one master thesis ( 39 ). Generally, young mothers experience motherhood positively, seeing it as a new chance and a possibility for stability in life. However, they also faced discrimination due to their age and stigmatisation because their maternal competencies were questioned. Some mothers wanted to prove their competence in motherhood, and breastfeeding their baby was an important symbol of that. Stigmatisation was found to impact their confidence, and some mothers rather consulted their network than health professionals if experiencing problems. Generally, mothers found it natural and desirable to breastfeed, but their intention to continue was challenged if breastfeeding after birth was difficult and demanding. Finally, mothers stressed the importance of short, concrete and visual support, and voiced their need for recognition. The review of effective breastfeeding interventions targeting young mothers and mothers with low educational attainment included seven intervention studies ( 40 – 46 ). They were difficult to summarise due to heterogeneity in content, timing, outcome measures and limited descriptions of the interventions. However, face-to-face interventions and interventions that included multiple elements seemed to positively impact breastfeeding duration. A general call for interventions based on psycho-social theories and interventions involving fathers or other close relations was found as social relations had a strong impact on breastfeeding outcomes. Drawing on four peer-reviewed studies ( 14 , 47 – 49 ) and a master thesis ( 39 ), the review underscored the importance of self-efficacy in breastfeeding among the target group. Experiences and attitudes towards breastfeeding in their close network influenced their own confidence in their ability to breastfeed. Moreover, the mothers described how concrete breastfeeding support, confirmation and personal recognition contributed to motivating and maintaining breastfeeding when facing challenges, stressing the importance of targeting self-efficacy in interventions. Stakeholder consultation The needs assessment was based on interviews with eight mothers and five fathers, observations of seven health visitors’ home visits, observation of one mother support group with 15 young mothers, and four focus group interviews with 24 health visitors ( 16 ). All mothers in the interviews and observations had a low educational attainment and six of the eight mothers were younger than 25 years. Albeit selected to represent mothers in vulnerable positions, the participants experienced considerable differences in their life situations due to differences in degrees of stability in work, economy, cohabitation and mental health; challenges in their maternal role; experiences of stigmatisation; and support from their network. These contextual differences influenced their breastfeeding journey and their breastfeeding self-efficacy, which again emphasised the importance of individual breastfeeding support and a positive, recognising relationship between parents and health professionals. Parents themselves also explicitly underscored the importance of individualised support. During pregnancy, all parents wanted their baby to be breastfed. Because they thought breastfeeding would come naturally, parents in general and the fathers in particular saw no need for preparation in pregnancy, which both parents ended up regretting. After birth, most parents were surprised that breastfeeding was not as easy as they had expected and that they faced several practical challenges, like good positioning, timing of breastfeeding and getting the baby to latch on. Understanding the baby’s cues was difficult for some mothers, and a crying baby was experienced as a marker for breastfeeding problems and sometimes also as a critique of them as parents. Hence, a thorough, realistic breastfeeding preparation covering the practical challenges was important to include in the intervention. Most parents experienced challenges during breastfeeding, mostly pain and experiences of insufficient milk production. They stressed that their choice of breastfeeding support depended on accessibility, usefulness and attitudes like their own towards breastfeeding. Moreover, many preferred receiving help from their social network. They used the internet to search for assistance and valued short, practical answers and videos. The use of health visitors for assistance depended on the meeting between health visitors and the parents, including the relationship, communication with both parents and the importance of working towards the same goal. Especially the health visitors stressed the importance of visits during pregnancy to initiate the good relation, facilitate a preparation process and involve the fathers. In the MBI, it would be important to include relational and communicative elements. Moreover, it could be important to combine face-to-face support with digital support, which is accessible 24 hours a day. For many mothers, it took time to establish successful breastfeeding, and the emotional impact of their breastfeeding experiences had a major effect on their breastfeeding self-efficacy. Insecurity about whether the baby got enough milk and about the family’s general well-being were essential in all families regardless of the feeding method. Frequent breastfeeding, especially during night, insecurity of whether the baby got enough milk and having time for yourself were arguments for cessation of breastfeeding. On the other hand, a strong motivation and confidence in breastfeeding were driving forces for breastfeeding. None of the mothers who had stopped breastfeeding had asked for support from the health visitors during the decision-making process, which was also the health visitors’ general experience, causing a great deal of frustration. In the end, all that mattered was that parents were certain that their baby got enough food; whether it was bottle-feeding or breastfeeding was secondary. However, if bottle-feeding was chosen, the mothers retained a big wish to breastfeed their next baby but were also in doubt about their ability to do so. Informed by this needs assessment, the new families might benefit from a self-efficacy-supported intervention with a specific focus on how to assess that the baby was getting enough milk and a proactive approach that might catch early breastfeeding problems before they lead to termination of breastfeeding among mothers wishing to breastfeed. Stage 2: Co-production The findings from stage 1 and the HBI were the basis for the co-production in the working group, where the intervention was created, including supportive materials such as a dialogue sheet, a pamphlet to assess the infant’s thriving, a postcard including the four main messages, a website with text, videos and podcasts, and a manual for health visitors. Table 1 shows how the needs and attentions were addressed in MBI. Table 1. Overview of identified attention points and needs addressed in the Municipality Breastfeeding Intervention. Identified attention points and needs Addressed in the Municipality Breastfeeding Intervention Attention towards the feeling of stigma due to age and the need for recognition Creating a good relationship between health visitor and family, supported by a dialogue sheet introduced during the pregnancy visit. Recognition and support tailored to individual needs, wishes and goals of the family using communication based on theory of self-efficacy. Attention towards challenged breastfeeding if early breastfeeding was difficult and demanding Close proactive follow-up by health visitors in the first two months following birth. Podcasts with experiences of other parents to increase self-efficacy (vicarious experiences). Need for short, concrete and visual support Practical face-to-face support in concrete situations and practical and concrete online videos are needed to provide the family with good experiences to enhance self-efficacy and action competence. Need for the involvement of both parents One of the four key messages. Promoting the importance of the father/partner being part of the home visits. Videos and podcasts of fathers’ experiences of his role as a father to a breastfed baby. Attention towards the impact of contextual factors, including a close network of the individual parents on breastfeeding Individual support is based on the parents’ concrete entire situation. Use of a dialogue sheet for the first meeting to support initiating an individual need-based counselling. Knowledge about the positive and negative impacts of breastfeeding from the close network. Need for realistic expectations towards breastfeeding during pregnancy Pregnancy visits by the health visitor include identifying expectations, wishes and motivation for breastfeeding. Knowledge of breastfeeding initiation available online, including breastfeeding experiences provided by other parents. Need for knowledge of practical breastfeeding matters Practical knowledge of breastfeeding positions, understanding baby’s cues, sucking techniques, signs of thriving etc., including instructive videos. A pamphlet on assessing if the baby was getting enough milk, what to do if the baby got too little and when to ask for professional help. Need for specific support regarding breastfeeding pain and experiences of insufficient milk production An online toolbox was available with concrete, practical proposals to solve pain and experiences of insufficient milk production, including instructive videos. Need for a respectful and appreciative relationship with the health visitor Focus on establishing a good relationship with the parents. Attention towards not asking health visitors for support if breastfeeding is challenging Explicitly communicate that the health visitor is there to help parents achieve their desired goals. Communicate to the parents what they can use the health visitor for. Need for valid online access to breastfeeding support 24 hours a day Website with evidence-based knowledge on breastfeeding. Need for access to knowledge of how to bottle-feed the baby Podcasts on how to bottle-feed the baby and parent’s experiences with bottle-feeding. In the adaptation process of the HBI to match the community setting, we identified differences between the two interventions and what to add under each of the four messages. Skin-to-skin contact was proposed to be used much more in the municipalities for creating peace positive relations and solving breastfeeding problems. In the HBI, we emphasised frequent breastfeeding in the initiation period, whereas in the MBI, the focus shifted to needs-based breastfeeding. Breastfeeding positions should be more open for alternative positions than the traditional upright position, and early involvement of the father should be prioritised, preferable in pregnancy. The communication part was informed by Bandura’s theory of self-efficacy, including the four sources to enhance self-efficacy: enactive mastery experiences, vicarious experiences, verbal persuasion and physiological and affective states ( 28 ). The theory was integrated into all communicative parts of the intervention, from the instructions for the face-to-face support in the manual for health visitors to the texts, videos, and podcasts on the website for parents. The operationalisation of the four sources to enhance self-efficacy is described in Fig. 4. Concurrently, health visitors in each municipality revised the digital routine record system to allow for reporting of the intervention activities. The routine home visit profile of the health visitors is determined by municipal policies (as a local area of government) and therefore varies slightly between the participating municipalities. We found no effective profile in the literature for scheduled home visits. Therefore, the profile for the basic intervention was developed based on the health visitors’ experiences and knowledge about when potential breastfeeding problems might arise in the families. In most of the municipalities, a home visit was offered when the baby was 4 months old. During this visit, families were guided to introduce complementary foods to the baby. Our hypothesis was that this visit might arouse parents’ curiosity and stimulate them to introduce complementary food for the baby before intended, thereby shortening the exclusive breastfeeding duration. Thus, in the intervention, the 4-month visit was substituted by a 4-month telephone call during which the health visitor and the family would plan a home visit for the introduction of complementary food according to the individual family’s breastfeeding process and needs. The final profile of the home visits and telephone calls are shown in Supplementary Table 2. For the intensified intervention, we wanted to enhance needs-based communication by enabling more frequent contact between the families and the health visitors. The purpose of this was to identify early breastfeeding challenges, support with problem-solving and thereby address the identified problem in stage 1 of mothers not reaching out to the health visitor when needing support. Therefore, we decided that the intensified intervention should consist of scheduled proactive calls. Inspiration was found in a Danish study where proactive telephone calls were found to enhance exclusive breastfeeding at 3 months with a factor 2.5 in a group of overweight/obese mothers ( 50 ). Hence, the intensified intervention offered a higher dose of the intervention based on the same breastfeeding principles as in the basic intervention. It was a balancing act to ensure consistency between health visitors’ support and offer an individual approach. We made supportive guidelines for all visits and telephone calls (not to be followed slavishly). To stimulate an individual approach, we designed the initiation of the visit to be an open question to the family about their general well-being, how breastfeeding was going and if anything worried them. The final profile of home visits was approved by the managers of the health visiting program. In addressing social inequity in breastfeeding during the development process, we constantly strove to find a balance between reaching the group of young mothers and mothers with low educational attainment and not labelling and stigmatising them. In stage one, we identified the importance of a good relationship built on trust and a sense of security between the mothers in this group and the health visitors to address this issue. To enable the health visitors to engage in tailored and individualised support to the families, we developed a communication tool aiming to open a conversation about the families’ unique needs and goals for breastfeeding. The tool underwent a complicated back and forward adaptation process. Initially, we proposed a mind-mapping technique, which was introduced at an LCM and tested in role-play exercises. However, after testing it out with families, the health visitors found it too demanding for this project. We opted for a simpler tool, entitled the dialogue sheet, where the health visitor and the family in a joint process were supposed to identify the unique needs and wishes based on icons of essential elements of importance to breastfeeding. The dialogue sheet should optimally be introduced at the pregnancy visit or alternatively at the first home visit after birth. In stage 1, both parents and health visitors proposed a website with simple, practical, evidence-based knowledge about breastfeeding and instructive videos that were available when needed 24/7. Based on the needs in stage 1, we presented and agreed on a frame for the web app with nine topics at the LCM. The web app had three layers, which accommodated different levels of knowledge among users, and the four key messages were the foundation of all information. Fifteen practical videos were produced with voice-over, explaining and describing what the videos were showing and thereby focused on vicarious experiences as a source to increase self-efficacy. The topics of the videos were, among others, breastfeeding positions, baby’s feeding cues, sucking technique and preparing for breastfeeding in pregnancy. Eight podcasts were produced to provide parents with experiences and tips from other parents with among others breastfeeding initiation and how partners supported the breastfeeding mothers. The topic ‘preparing for breastfeeding’ included a quiz, where parents could compete on knowledge and myths about breastfeeding to stimulate their interest in breastfeeding during pregnancy and contribute to providing a realistic perspective on breastfeeding. Finally, the web app included a toolbox of proposals for solving the two main problems causing early cessation of breastfeeding: pain and perceived insufficient milk. Other materials produced during stage 2 were a postcard with the four key messages, a link to the web app, and a pamphlet to support parents considering whether their baby got enough milk, including information on a minimum number of daily breastfeedings, normal stool and urination, feeding cues, other signs of well-being, a ‘what to do guide’ if things were not as described, and when to contact health professionals for more assistance. A similar pamphlet had earlier been used in one region in Denmark. The pamphlet was valued by parents and health professionals because it provided parents with the competence to act and self-efficacy when insecure about their baby’s thriving. The pamphlet was updated according to evidence and redesigned to fit the other materials of the MBI. All materials were produced in Danish and English versions, including the web app and all the videos. A new intervention training program was developed based on the HBI but adapted to the families’ post-discharge needs and the health visitors’ needs. A draft of a program was presented and discussed at the LCM. When the municipalities agreed to participate in the project, they signed a document permitting all health visitors to participate in a course encompassing three hours of e-learning and a subsequent two-day training course. The theoretical e-learning preceding the training course gave us the possibility to include more interactive learning in the course, such as discussions, reflections, exercises and role-plays to enhance the health nurses’ self-efficacy and action competency to deliver the intervention, as also recommended in previous interventions ( 51 , 52 ). The final program of the e-learning consisted of theoretical input about the anatomy and physiology of breastfeeding, skin-to-skin contact, self-efficacy and an introduction to the dialogue sheet. The two-day training course covered the following topics: Breastfeeding – a joint parental task, the social context of breastfeeding and its impact on breastfeeding, preparing for breastfeeding, the relation between health visitor and parents, breastfeeding positions and suckling technique, breastfeeding on demand, pain and sore nipples, how to tailor support to the individual family, and enhancing self-efficacy in practice. The intervention material was activated during the training. A detailed program theory for the training program and evaluation of effectiveness on health visitors’ breastfeeding knowledge, self-efficacy and action competence is described elsewhere ( 53 ). The entire breastfeeding intervention was mapped in a program theory, including activities, mechanisms, output, outcomes, impact and context for both target groups. See Fig. 5 a and 5 b. Stage 3: Prototyping Most of the pilot testing was performed during the co-production phase as described earlier. Feedback from the health visitors’ testing and discussions with colleagues in the LCM gave rise to several changes, such as the dialogue sheet mentioned above. Other material was tested in families and found useful, such as the pamphlet to support parents’ assessment of the baby’s thriving. The review of the manual ( 53 ) by two breastfeeding experts gave rise to small adjustments. The web-app was carefully tested by experts to identify potential dead ends and ensure that links were working as intended. Five parent couples were asked to assess the content for usefulness and relevance. Consequently, the quiz was divided into three parts as it was found too long for a single session. A pilot test of ‘Breastfeeding – a good start together’ was conducted after all health visitors in the 10 intervention municipalities had completed the training course. During the 2.5-month implementation period health visitors implemented the intervention in the families. Tips and challenges were collected and solved at dialogue meetings in the working group, and the intervention was revised accordingly. Especially practical problems with the web-app were identified as were also challenges implementing the dialogue sheet in the initial home visits after birth. Hence, we decided that the dialogue sheet should be used in the families only during pregnancy visits when undisturbed dialogue is more feasible. This decision was made to address the challenges of engaging in such discussions after birth when families are adjusting to life with a newborn. After the final approval by the health visitors, the MBI was ready for evaluation. Discussion This study contributes to the evidence on how to optimize breastfeeding support to new families after discharge from maternity hospital in general and young mothers and mothers with low educational attainment in particular. Moreover, it contributes with insights into the development of a complex public health intervention by testing Hawking’s three-stage framework including 1) evidence review and stakeholder consultation 2) co-production and 3) prototyping ( 21 ), informed by O’Cathain’s five key working principles and ten key actions for development ( 22 ). We hereby make our experiences available, including strengths and weaknesses of the co-production approach, experiences with prototyping and considerations of developers’ positioning. Strength and weaknesses of the framework and working principles Following Hawkin’s three-stage framework and O’Cathain’s working principles was crucial for tailoring the intervention content to the target group and the setting during the design stage. While this process was time-consuming, it proved very valuable. The working principles suggest an iterative, creative and open-minded process. We followed these principles and found them especially valuable for the intervention when considering the inclusion of a digital solution and for developing an instrument for supporting a tailored and individual approach (dialogue sheet). The democratic and joint learning back-and-forth processes between developers and health visitors in the working group took time. Having a time schedule with space for unforeseen issues was therefore paramount. However, this approach also assumes strict time management as it would be tempting to keep on working to get the optimal solution, an experience shared by other developers of complex interventions ( 54 ). The framework and the working principles also suggested a co-creation approach. In this study, we involved health visitors from the participating municipalities during all three stages. Parents were involved in stage one (stakeholder consultation) and stage three (intervention prototyping). The development process might have benefitted even more if parents had been involved in the entire process, bringing their opinions into the discussions. A process evaluation, which is about to be published, has shown that the dialogue sheet was not adopted in its entirety by the health visitors, although it was valued especially by the fathers. Thus, further testing during the development stage could have been warranted. Bringing the two target groups together might have been beneficial for discussing the usefulness and the final production of the instrument. This collaboration would have been an important step in targeting breastfeeding support to the families’ unique needs. Among health visitors, the co-creation process resulted in great engagement and ownership of the intervention, which was a driving force during its implementation. A prerequisite for the municipalities’ involvement of health visitors from practice was reimbursement for the time spent during the development phase. Therefore, the budget for the entire research project must include payment to the municipalities to ensure that involvement in the project does not negatively impact the support offered to families during this period. Developers’ positioning The two developers’ central positioning in the breastfeeding landscape in Denmark may have played a positive and important role during the development of the intervention. Being advisors to the National Board of Health, the authors of the national recommendations, breastfeeding trainers of health visitors in Denmark and having a good insight into health visitors’ field of work have possibly positively influenced the development of the new intervention and facilitated its subsequent implementation. However, it might also have introduced bias into the process due to blind spots or an uneven perception of breastfeeding authority, potentially causing the visiting nurses to withhold ideas and perspectives. Conclusion This comprehensive description of the development of a complex intervention based on the framework of Hawkin and O’Cathain is an example of how to co-produce and prototype a breastfeeding intervention aimed to increase the duration and reduce inequity in breastfeeding in collaboration with parents and health professionals. We illuminate how the needs and attentions identified in stage 1 are processed and addressed in the intervention and how the intervention is tested and adapted to the specific context during stages 2 and 3. This project partly mitigates the limited guidance and research on the development stage. The description provides breastfeeding practitioners and researchers with a transparent foundation for the ongoing qualification of breastfeeding support and methodology on complex intervention development. Abbreviations HBI = Hospital-Based Intervention LCM = Learning Cycle Meeting MBI = Municipality Based Intervention MRC = Medical Research Counsil SEP = Socio-economic position Declarations Ethics approval and consent to participate According to the Helsinki Declaration, all participants were informed about the study both verbally and in writing. Informed written consent to collect and safely store data and publish results of the study was obtained. Hence, participant information and data protection comply with the General Data Protection Regulation (GDPR). As this study is not a trial and does not include human tissues, ethics approval is not required by Danish law. Availability of data and materials The data used for stage 1 are available from the first author on reasonable request. Competing interests The authors declare that the funding interests may be considered as potential competing interests Funding This study was supported by NordeaFonden (grant number 02-2019-00267) and Det Obelske Familiefond (grant number 29763). The funding sources had no influence of the study during the entire process from idea to decision to submit the article for publication. Authors contribution IN, MBR and SFV have made substantial contributions to the conception of the research, the design of the work, the acquisition, and the interpretation of data. IN has drafted the work and SFV and IN has substantively revised it. IN, MBR and SFV have approved the submitted version and agreed both to be personally accountable for the author's own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature. Acknowledgments First and foremost, the authors thank mothers, fathers and health visitors for participating in the study. Likewise, we thank Anne Oehlers for her assistance during the focus-group interviews and the subsequent transcriptions. References WHO. Global strategy for infant and young child feeding. World Health Organization; 2003. Victora CG, Bahl R, Barros AJ, França GV, Horton S, Krasevec J, m.fl. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. The Lancet. 2016;387(10017):475–90. Pérez-Escamilla R, Tomori C, Hernández-Cordero S, Baker P, Barros AJD, Bégin F, m.fl. Breastfeeding: crucially important, but increasingly challenged in a market-driven world. The Lancet. February 2023;401(10375):472–85. Bruun S, Wedderkopp N, Mølgaard C, Kyhl HB, Zachariassen G, Husby S. Using text messaging to obtain weekly data on infant feeding in a Danish birth cohort resulted in high participation rates. Acta Paediatr. June 2016;105(6):648–54. Sundhedsdatastyrelsen, Denmark [Internet]. 2022. The National Children’s Database. Tilgængelig hos: https://www.esundhed.dk/Registre/Den-nationale-boernedatabase/Foerste-leveaar Bærug A, Laake P, Løland BF, Tylleskär T, Tufte E, Fretheim A. Explaining socioeconomic inequalities in exclusive breast feeding in Norway. Arch Dis Child. February 2017;archdischild-2016-312038. Ibanez G, Martin N, Denantes M, Saurel-Cubizolles MJ, Ringa V, Magnier AM. Prevalence of breastfeeding in industrialized countries. Rev DÉpidémiologie Santé Publique. August 2012;60(4):305–20. Johansen A, Krogh C, Weber Pant S, Holstein BE. Amning: Temarapport og årsrapport. Børn født i 2014. København: Databasen Børns Sundhed og Statens Institut for Folkesundhed, SDU.; 2016. Sacker A, Kelly Y, Iacovou M, Cable N, Bartley M. Breast feeding and intergenerational social mobility: what are the mechanisms? Arch Dis Child. September 2013;98(9):666–71. Victora CG, Horta BL, de Mola CL, Quevedo L, Pinheiro RT, Gigante DP, m.fl. Association between breastfeeding and intelligence, educational attainment, and income at 30 years of age: a prospective birth cohort study from Brazil. Lancet Glob Health. April 2015;3(4):e199–205. Kronborg H, Foverskov E. Multifactorial influence on duration of exclusive breastfeeding; a Danish cohort study. Yourkavitch J, redaktør. PLOS ONE. September 2020;15(9):e0238363. McFadden A, Gavine A, Renfrew MJ, Wade A, Buchanan P, Taylor JL, m.fl. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Pregnancy and Childbirth Group, redaktør. Cochrane Database Syst Rev [Internet]. February 2017 http://doi.wiley.com/10.1002/14651858.CD001141.pub5 Dykes F, Moran VH, Burt S, Edwards J. Adolescent Mothers and Breastfeeding: Experiences and Support Needs—An Exploratory Study. J Hum Lact. January 2003;19(4):391–401. Entwistle F, Kendall S, Mead M. Breastfeeding support - the importance of self-efficacy for low-income women. Matern Child Nutr [Internet]. september 2009. http://doi.wiley.com/10.1111/j.1740-8709.2009.00202.x Hunter L, Magill-Cuerden J, McCourt C. Disempowered, passive and isolated: how teenage mothers’ postnatal inpatient experiences in the UK impact on the initiation and continuation of breastfeeding: Postnatal inpatient experiences and breastfeeding. Matern Child Nutr. January 2015;11(1):47–58. Nilsson I, Busck-Rasmussen M, Rossau HK, Villadsen SF. Breastfeeding trajectories of young and short-term educated mothers and their partners; experiences of a journey facing tailwind and headwind. Midwifery. October 2022;113:103436. Sheeran N, Jones L, Rowe J. Joys and challenges of motherhood for Australian young women of preterm and full-term infants: an Interpretative Phenomenological Analysis. J Reprod Infant Psychol. October 2015;33(5):512–27. Kronborg H, Væth M, Olsen J, Iversen L, Harder I. Effect of early postnatal breastfeeding support: a cluster-randomized community based trial. Acta Paediatr. 2007;96(7):1064–70. Nilsson I, Strandberg-Larsen K, Knight CH, Hansen AV, Kronborg H. Focused breastfeeding counselling improves short- and long-term success in an early-discharge setting: A cluster-randomized study. Matern Child Nutr. 2017;13(4):e12432. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, m.fl. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. September 2021;n2061. Hawkins J, Madden K, Fletcher A, Midgley L, Grant A, Cox G, m.fl. Development of a framework for the co-production and prototyping of public health interventions. BMC Public Health. September 2017;17(1):689. O’Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, m.fl. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. August 2019;9(8):e029954. Rossau HK, Nilsson IMS, Busck-Rasmussen M, Ekstrøm CT, Gadeberg AK, Hirani JC, m.fl. Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial. BMC Public Health. March 2023;23(1):450. Sundhedsstyrelsen (Danish Health and Medicines Authority). Sundhedsstyrelsens anbefalinger for svangreomsorgen. 2021. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. September 2008;a1655. Craig P, Di Ruggiero E, Frohlich KL, Mykhalovskiy E, White M, on behalf of the Canadian Institutes of Health Research (CIHR)–National Institute for Health Research (NIHR) Context Guidance Authors Group (listed alphabetically), m.fl. Taking account of context in population health intervention research: guidance for producers, users and funders of research. 2018 Apr https://www.journalslibrary.nihr.ac.uk/nihr-research/canadian-institutes-of-health-research-cihr-and-nihr-collaboration.htm Duncan E, O’Cathain A, Rousseau N, Croot L, Sworn K, Turner KM, m.fl. Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study. BMJ Open. April 2020;10(4):e033516. Bandura, Albert. Self-Efficacy: The Exercise of Control. 1st edition. New York: Worth Publishers; 1997. 604 s. Kreuter MW, Bull FC, Clark EM, Oswald DL. Understanding how people process health information: A comparison of tailored and nontailored weight-loss materials. Health Psychol. September 1999;18(5):487–94. Green B, Johnson C, Adams A. Writing narrative literature reviews for peer-reviewed journals: secrets of the trade. J Chiropr Med. 2006;5(3):101–7. Øhlers, A, Nilsson, I I. [Breastfeeding among young and short-educated mothers. A narrative literature review] Amning blandt unge og kortuddannede mødre. Et narrativt litteraturstudie. [Internet]. Copenhagen, Denmark: Danish Committee for Health Education; 2021. Online: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/http://www.kompetencecenterforamning.dk/media/193570/amning_blandt_unge_febr2021.pdf Malterud K. Systematic text condensation: A strategy for qualitative analysis. Scand J Public Health. December 2012;40(8):795–805. Duus, G, Husted, M, Kildedal, K, Laursen, E, Tofteng, D. Aktionsforskning - en grundbog. 1. edition. Bd. 2014. Samfundslitteratur; 2014. Lauttamäki V. ACTVOD-futures workshop – a generic structure for a one-day futures workshop. Foresight J Futur Stud Strateg Think Policy. 2016;18(2):156–71. Erfina E, Widyawati W, McKenna L, Reisenhofer S, Ismail D. Adolescent mothers’ experiences of the transition to motherhood: An integrative review. Int J Nurs Sci. April 2019;6(2):221–8. Hunter L, Magill-Cuerden J. Young mothers’ decisions to initiate and continue breastfeeding in the UK: tensions inherent in the paradox between being, but not being able to be seen to be, a good mother. Evid Based Midwifery. 2014;12(2):46–51. Noble-Carr D, Bell C. Exposed: younger mothers and breastfeeding. Breastfeed Rev Prof Publ Nurs Mothers Assoc Aust. November 2012;20(3):27–38. Wahn EH, Nissen E, Ahlberg BM. Becoming and Being a Teenage Mother: How Teenage Girls in South Western Sweden View Their Situation. Health Care Women Int. August 2005;26(7):591–603. Rasmussen JS. Unge førstegangsmødres oplevelse af ammeforløbet med fokus på beslutningstagen [Kandidatuddannelsen i Jordemodervidenskab]. Syddansk Universitet; 2018. Kaunonen M, Hannula L, Tarkka MT. A systematic review of peer support interventions for breastfeeding: Support for breastfeeding . J Clin Nurs. July 2012;21(13–14):1943–54. Meglio GD, McDermott MP, Klein JD. A Randomized Controlled Trial of Telephone Peer Support’s Influence on Breastfeeding Duration in Adolescent Mothers. Breastfeed Med. February 2010;5(1):41–7. Mejdoubi J, van den Heijkant SCCM, van Leerdam FJM, Crone M, Crijnen A, HiraSing RA. Effects of nurse home visitation on cigarette smoking, pregnancy outcomes and breastfeeding: A randomized controlled trial. Midwifery. June 2014;30(6):688–95. Pugh LC, Milligan RA, Frick KD, Spatz D, Bronner Y. Breastfeeding Duration, Costs, and Benefits of a Support Program for Low-Income Breastfeeding Women. Birth. June 2002;29(2):95–100. Srinivas GL, Benson M, Worley S, Schulte E. A Clinic-Based Breastfeeding Peer Counselor Intervention in an Urban, Low-Income Population: Interaction with Breastfeeding Attitude. J Hum Lact. February 2015;31(1):120–8. Volpe EM, Bear M. Enhancing Breastfeeding Initiation in Adolescent Mothers Through the Breastfeeding Educated and Supported Teen (BEST) Club. J Hum Lact. August 2000;16(3):196–200. Wambach KA, Aaronson L, Breedlove G, Domian EW, Rojjanasrirat W, Yeh HW. A Randomized Controlled Trial of Breastfeeding Support and Education for Adolescent Mothers. West J Nurs Res. June 2011;33(4):486–505. Bailey J, Clark M, Shepherd R. Duration of breastfeeding in young women: psychological influences. Br J Midwifery. March 2008;16(3):172–8. Mossman M, Heaman M, Dennis CL, Morris M. The Influence of Adolescent Mothers’ Breastfeeding Confidence and Attitudes on Breastfeeding Initiation and Duration. J Hum Lact. January 2008;24(3):268–77. Nilsson IMS, Kronborg H, Rahbek K, Strandberg‐Larsen K. The significance of early breastfeeding experiences on breastfeeding self‐efficacy one week postpartum. Matern Child Nutr. July 2020. https://onlinelibrary.wiley.com/doi/abs/10.1111/mcn.12986 Carlsen EM, Kyhnaeb A, Renault KM, Cortes D, Michaelsen KF, Pryds O. Telephone-based support prolongs breastfeeding duration in obese women: a randomized trial. Am J Clin Nutr. November 2013;98(5):1226–32. Dykes F. The education of health practitioners supporting breastfeeding women: time for critical reflection. Matern Child Nutr. October 2006;2(4):204–16. Kronborg H, Vaeth M, Olsen J, Harder I. Health visitors and breastfeeding support: influence of knowledge and self-efficacy. Eur J Public Health. February 2008;18(3):283–8. Rossau HK, Nilsson I, Villadsen SF. Strengthening health visitors’ breastfeeding support - results from a cluster randomised study. Nurse Education in Practice. 2024;78(July 2024). Maindal HT, Timm A, Dahl-Petersen IK, Davidsen E, Hillersdal L, Jensen NH, m.fl. Systematically developing a family-based health promotion intervention for women with prior gestational diabetes based on evidence, theory and co-production: the Face-it study. BMC Public Health. December 2021;21(1):1616. Additional Declarations Competing interest reported. The authors declare that the funding interests may be considered as potential competing interests. However, the funding sources had no influence of the study during the entire process from idea to decision to submit the article for publication. Supplementary Files SupplTable1final.docx SupplTable2final.docx Cite Share Download PDF Status: Published Journal Publication published 02 Oct, 2024 Read the published version in Archives of Public Health → Version 1 posted Editorial decision: Revision requested 02 Sep, 2024 Reviews received at journal 28 Aug, 2024 Reviews received at journal 26 Aug, 2024 Reviewers agreed at journal 20 Aug, 2024 Reviewers agreed at journal 20 Aug, 2024 Reviewers agreed at journal 19 Aug, 2024 Reviews received at journal 12 Aug, 2024 Reviewers agreed at journal 12 Aug, 2024 Reviewers invited by journal 12 Aug, 2024 Editor assigned by journal 05 Jul, 2024 Submission checks completed at journal 05 Jul, 2024 First submitted to journal 30 Jun, 2024 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-4662366","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":326398024,"identity":"cdb87ac6-cab6-46a9-ae41-a542fd1cceb4","order_by":0,"name":"Ingrid Nilsson","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAnElEQVRIiWNgGAWjYBACNgbmA0CK2QDEkWwgTgtbAolaGBh4DEjUwifd8/kz7w5rY36xA4w3ZxDlMJmz26R5z6SbSc5OYLbcQJQWidxtzLxth20MbiewST4gTkvO488ka2GQBmoxA2sh0mFpZpJz29KNJWcnNlsS5X35GcmPP7xtszbsl04+eLOHGC1IgLGBRA2jYBSMglEwCnACABC0LLEWjDjUAAAAAElFTkSuQmCC","orcid":"","institution":"Danish Committee for Health Education","correspondingAuthor":true,"prefix":"","firstName":"Ingrid","middleName":"","lastName":"Nilsson","suffix":""},{"id":326398025,"identity":"a5d5daba-8dda-4ef6-9299-5f615dbaa7f7","order_by":1,"name":"Marianne Busck-Rasmussen","email":"","orcid":"","institution":"Danish Committee for Health Education","correspondingAuthor":false,"prefix":"","firstName":"Marianne","middleName":"","lastName":"Busck-Rasmussen","suffix":""},{"id":326398026,"identity":"a91f3b0f-b026-4097-8b4c-2613da632cc0","order_by":2,"name":"Sarah Fredsted Villadsen","email":"","orcid":"","institution":"University of Copenhagen","correspondingAuthor":false,"prefix":"","firstName":"Sarah","middleName":"Fredsted","lastName":"Villadsen","suffix":""}],"badges":[],"createdAt":"2024-06-30 10:51:33","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4662366/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4662366/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13690-024-01401-6","type":"published","date":"2024-10-02T15:57:34+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":62123962,"identity":"4f7ff48b-a329-4bc1-b0e7-5601bfd26ae3","added_by":"auto","created_at":"2024-08-09 14:26:06","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":223755,"visible":true,"origin":"","legend":"\u003cp\u003eThe Municipality-Based Intervention\u003c/p\u003e","description":"","filename":"Figure1final.png","url":"https://assets-eu.researchsquare.com/files/rs-4662366/v1/0d49eb505dbe6b550bd8a903.png"},{"id":62123965,"identity":"4d8d6cbe-12ed-4668-92f3-89ea93d1910b","added_by":"auto","created_at":"2024-08-09 14:26:06","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":278984,"visible":true,"origin":"","legend":"\u003cp\u003eThe method used during the development phase\u003c/p\u003e","description":"","filename":"Figure2final.png","url":"https://assets-eu.researchsquare.com/files/rs-4662366/v1/09a11fe34319767a3f9430f2.png"},{"id":62123967,"identity":"78f4cc03-982b-4599-87b8-2f6eb662c415","added_by":"auto","created_at":"2024-08-09 14:26:06","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":337958,"visible":true,"origin":"","legend":"\u003cp\u003eContent of learning cycle meetings\u003c/p\u003e","description":"","filename":"Figure3final.png","url":"https://assets-eu.researchsquare.com/files/rs-4662366/v1/aa8097399e6f214531cf0d85.png"},{"id":62125195,"identity":"62951938-1880-4e03-aec7-cc720ebcea62","added_by":"auto","created_at":"2024-08-09 14:34:06","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":267950,"visible":true,"origin":"","legend":"\u003cp\u003eOperationalisation of Bandura’s four sources to increase self-efficacy\u003c/p\u003e","description":"","filename":"Figure4final.png","url":"https://assets-eu.researchsquare.com/files/rs-4662366/v1/47cd283d510b6c6efa952b8d.png"},{"id":62123968,"identity":"3623d1a8-0851-41cf-a98d-f0acf0a15b59","added_by":"auto","created_at":"2024-08-09 14:26:06","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":1902559,"visible":true,"origin":"","legend":"\u003cp\u003ea. Programme theory of parents’ gain from the municipality-based breastfeeding Intervention\u003c/p\u003e\n\u003cp\u003eb. Programme theory of health visitors’ gain from the training program\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-4662366/v1/6b08f60f04375c9afed9d922.png"},{"id":66097618,"identity":"b46fed08-f190-4e6b-abe9-39ddd70012eb","added_by":"auto","created_at":"2024-10-07 16:14:44","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":3393013,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4662366/v1/cfc7d4f8-15de-4aaf-b5e9-69822e3df011.pdf"},{"id":62123961,"identity":"f7cbafd0-8f00-4842-a539-9a3c5445bef4","added_by":"auto","created_at":"2024-08-09 14:26:06","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":30931,"visible":true,"origin":"","legend":"","description":"","filename":"SupplTable1final.docx","url":"https://assets-eu.researchsquare.com/files/rs-4662366/v1/a47568d663c3133837d028d1.docx"},{"id":62123964,"identity":"433d8900-0ed1-4afe-94a4-3999d5e2ce96","added_by":"auto","created_at":"2024-08-09 14:26:06","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":30557,"visible":true,"origin":"","legend":"","description":"","filename":"SupplTable2final.docx","url":"https://assets-eu.researchsquare.com/files/rs-4662366/v1/1ebb8ba8e17af2f636cb8ab7.docx"}],"financialInterests":"Competing interest reported. The authors declare that the funding interests may be considered as potential competing interests. However, the funding sources had no influence of the study during the entire process from idea to decision to submit the article for publication.","formattedTitle":"Development of a complex intervention to strengthen municipality-based breastfeeding support to reduced social inequity in breastfeeding","fulltext":[{"header":"Contributions to the literature","content":"\u003cul\u003e\n \u003cli\u003eThere are considerable differences in breastfeeding duration due to social inequityg\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eWe lack knowledge on effective complex interventions to reduce breastfeeding inequity\u003c/li\u003e\n \u003cli\u003ePrior research encourages transparency into the development process of complex public health interventions\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eThis research provides insights into a co-creation process, where a breastfeeding intervention to reduce social inequity was developed\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eThis research facilitates the ongoing qualification of breastfeeding support for the benefit of new parents and their infant.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Background","content":"\u003cp\u003eExclusive breastfeeding is recognized by the World Health Organization (WHO) as the ideal nutrition globally for infants in their first six months of life, with continued breastfeeding recommended until the child reaches two years of age or beyond (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). A meta-analysis shows that the positive effects of breastfeeding benefit both mother and child during a lifespan (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). However, globally less than half of all infants are breastfed as recommended (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). In Denmark, where more than 97% of all mothers initiate breastfeeding (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e), 86% and 61% of infants are fully breastfed at the age of two weeks and four months, respectively (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn high-income countries, socio-demographic factors such as young age and low socio-economic position (SEP) can lead to early breastfeeding cessation (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). In Denmark, for instance, only 37% of mothers under 20 years and 39\u0026ndash;50% with a short-term vocational education breastfeed for four months (Johansen et al., 2016). This highlights the need for action (B\u0026aelig;rug et al., 2017). Addressing breastfeeding among mothers with a low SEP has been associated with increased odds of the child\u0026rsquo;s upward social mobility (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Breastfeeding may therefore also have social benefits (Victora et al., 2015). Research shows insights into effective components of breastfeeding support for mothers at high risk of early breastfeeding cessation. The prognostic effect of education on the duration of exclusive breastfeeding seems to disappear when adjusting for psychosocial factors such as breastfeeding self-efficacy and sense of security (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). This indicates that a strengthening of these psychological factors may diminish social inequity in breastfeeding duration.\u003c/p\u003e \u003cp\u003eA Cochrane review found that mothers at risk of early breastfeeding termination need more support from health professionals to obtain their own breastfeeding goals (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Thus, women in this group may need strengthened feedback and recognition of their efforts, which contribute to increasing their self-efficacy (\u003cspan additionalcitationids=\"CR14 CR15 CR16\" citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Despite insights from these basic research studies, to our knowledge, the number of comprehensive breastfeeding intervention studies targeting social inequity in breastfeeding is limited. From the general population, we know that interventions based on breastfeeding self-efficacy and evidence-based breastfeeding support can improve breastfeeding rates (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Thus, a need exists for the development of a complex intervention to reduce social inequity in breastfeeding.\u003c/p\u003e \u003cp\u003eAs improved breastfeeding support is a multifaceted intervention that operates across various structural layers, engaging multiple healthcare sectors, providers and families within their respective societal, local, and familial contexts, it can be defined as a complex intervention (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). To inform the development phase of public health interventions, Hawkins et al. developed a three-stage framework consisting of 1) evidence review and stakeholder consultation, 2) co-production and 3) prototyping (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). Furthermore, O\u0026rsquo;Cathain et al. point to five key working principles, which are described as dynamic, iterative, creative, open to change and looking towards evaluation, and ten key actions (plan the process, involve stakeholders, bring together a team, review published literature, draw on existing theories, articulate program theory, undertake primary data collection, understand context, pay attention to future implementation, design and refine) for development of complex interventions (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). Importantly, they encourage the publication of the development process to enable others to understand the challenges inherent in intervention development, to promote transparency about the choices made and to facilitate reflection on the link between intervention development and evaluation results (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eAn intervention, \u0026lsquo;Breastfeeding \u0026ndash; a good start together\u0026rsquo;, aiming to reduce social inequity through breastfeeding support has been developed in Denmark. The intervention builds on a previous intervention for all families from 2013-14 in Denmark. In this intervention, Nilsson et al. developed and implemented a hospital-based breastfeeding support intervention (HBI), see Supplementary Table\u0026nbsp;1 for further intervention description (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). The HBI trial analysis documented increased exclusive breastfeeding at six months and reduced infant readmissions within the first week of life in mother-infant dyads. However, breastfeeding self-efficacy was not affected (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Subsequently, health visitors in the municipalities have requested an intervention for breastfeeding support following discharge that is aligned with the HBI.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eAim\u003c/p\u003e \u003cp\u003eThe aim of this study is to present a systematic report of the adaptation and development phase of the intervention: \u0026lsquo;Breastfeeding \u0026ndash; a good start together\u0026rsquo;. Its overall purpose was to adapt the HBI to a municipality setting (hereafter the basic intervention) and add a newly developed intensified intervention for mothers with sociodemographic vulnerability (young age and low educational attainment) (hereafter intensified intervention) (Fig.\u0026nbsp;1). The intervention was implemented in Denmark using a cluster-trial design. Elaboration of the evaluation design can be found elsewhere (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eTarget groups and setting\u003c/p\u003e \u003cp\u003eThe new municipality-based breastfeeding intervention (MBI) had two target groups: the group receiving and the group delivering the intervention. The recipients were all new mothers and their partners. A specific subgroup of mothers, characterised by being under 25 years of age and/or having low educational attainment, would receive an intensified intervention as these sociodemographic aspects are associated with an increased risk of early breastfeeding cessation. Health visitors in the municipalities were the group that delivered the intervention.\u003c/p\u003e \u003cp\u003eThe adaptation and development study took place from August 2020 until December 2021 in 10 intervention municipalities in two Danish regions. These municipalities had a high frequency of mothers matching our target group, and breastfeeding rates were among the lowest in Denmark. Several of these municipalities had a high frequency of English-speaking inhabitants.\u003c/p\u003e \u003cp\u003eIn Denmark, families are offered breastfeeding support at the maternity ward after giving birth. After discharge, a universal, tax-financed, municipality-based health visiting program provides support in the families\u0026rsquo; homes (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). Given the short duration of hospitalisation after birth, the health visitors provide most of the breastfeeding support. About 97% of all new parents participate in the health visiting program. Danish health visitors are nurses with a minimum of three years of full-time clinical experience and subsequently 1.5 years of training.\u003c/p\u003e \u003cp\u003eMethod\u003c/p\u003e \u003cp\u003eThe overall framework used during the development of the MBI was the UK\u0026rsquo;s Medical Research Council (MRC) guidance for developing and evaluating complex interventions (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e) and later accompanying guidance supplements (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). The more practical processes in the developmental phase were informed by Hawkins et al.\u0026rsquo;s three-stage framework for the development of public health interventions (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) and O\u0026rsquo;Cathain\u0026rsquo;s five key working principles and ten key actions for development (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). A model of the method used is shown in Fig.\u0026nbsp;2. The reporting follows the GUIDED, a guideline for reporting intervention development studies in health research (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe research group was divided into two: one primarily responsible for the development phase (hereafter the developers) one, for the evaluation phase (hereafter the evaluators).\u003c/p\u003e \u003cp\u003eThe following describes the methods used during the three stages of development; however, the actual process had an iterative nature.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStage 1: Evidence review and stakeholder consultation\u003c/h2\u003e \u003cp\u003eThe MBI emerged from the evidence and experience of the HBI. To align the MBI with the HBI, the adaption process focused on tailoring it to the municipal setting and families\u0026rsquo; needs from week one after birth. Consequently, the essential elements of the new program were grounded in the four core evidence-based principles of the HBI: skin-to-skin contact, frequent breastfeeding, proper positioning and joint parenting tasks including theory-based communication. This part leaned on Bandura\u0026rsquo;s theory on self-efficacy (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e) and Kreuter\u0026rsquo;s theory of tailoring (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e). The intervention used the same overall strategies, training of healthcare professionals and educational material, to improve breastfeeding support. Furthermore, as the aim was to address social inequity in breastfeeding, the first step sought to build an understanding of the needs of young mothers and mothers with low educational attainment, and their partners\u0026rsquo; needs, to develop an intensified intervention component to meet their specific breastfeeding support needs.\u003c/p\u003e \u003cp\u003eTo get an overview of existing literature, we used Green et al.\u0026rsquo;s framework for narrative reviews (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e) to identify existing literature about experiences of being a mother and breastfeeding, effective breastfeeding interventions and the role of self-efficacy among young mothers and mothers with short education. The review included peer-reviewed publications in English and Nordic languages from 2000 to September 2020. Additionally, contemporary national reports and unpublished academic theses were also incorporated in the report (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). Search terms included combinations of the words breastfeeding, clinical trials, maternal educational achievement, and maternal age. Searches were made in PubMed and Cinahl.\u003c/p\u003e \u003cp\u003eTo further understand the need for an intervention, several qualitative methods were employed: individual interviews with mothers and fathers in the families\u0026rsquo; homes, observations of health visitors\u0026rsquo; home visits and observations of mother support groups offered by the municipality and led by health visitors. Inclusion was based on maternal age and length of education as defined earlier, whereas the fathers were the ones living with the included mothers and were therefore not covered by the maternal inclusion criteria. Finally, to include the health professionals\u0026rsquo; perspectives, focus group interviews with health visitors were performed. All interviews and observations were led by semi-structured guides.\u003c/p\u003e \u003cp\u003eAudio recordings of the individual and focus group interviews were transcribed verbatim and analysed along with field notes from the observations using Malterud\u0026rsquo;s four-step systematic text condensation (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e) and led by the study question \u0026ldquo;How do mothers of young age and short educational attainment and their partners experience breastfeeding and breastfeeding support and what has been supportive or challenging\u0026rdquo;. For more details on the method and analysis, see elsewhere (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStage 2: Co-production\u003c/h2\u003e \u003cp\u003eIn order to ensure a needs-based intervention, to qualify the interaction between theory and practice and to support the implementation process, we used a combined user-centred, co-creation and theory- and evidence-based approach (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). In the co-creation process, we wanted to enhance motivation and ownership and strengthen the implementation process by creating room for learning and reflection with health visitors and developers. The parents were involved through the interaction with health visitors.\u003c/p\u003e \u003cp\u003eA working group was formed consisting of two intervention developers from the National Competence Centre for Breastfeeding (IN and MBR) and one or two health visitors from each intervention municipality. Health visitors were appointed by the manager of the health visiting program in each municipality on the basis of being certified as international lactation consultants (IBCLC) or having a say in the local group of health visitors. A total of 13 health visitors from the 11 intervention municipalities and two developers were part of the working group, of which 11 were IBCLC. The health visitors were reimbursed for the time used for the project. The method \u0026lsquo;learning cycles\u0026rsquo; was used. Inspired by Duus et al., researchers and health professionals met and worked together to develop new knowledge for practice (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eA core element of the co-production process was the learning cycle meetings (LCM) (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). At these meetings, the working group met for five 6-hour meetings during the development phase to discuss, propose and test ideas generated in stage 1, and give feedback on the agreed homework in between meetings. Homework included pilot-testing of intervention elements in the families for feasibility and discussion of the usefulness and practical adaptability of the elements with their local colleagues. We initiated the development in the first LCM by presenting results from stage 1 and subsequently performing a future workshop (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e) to stimulate ideas for the optimal breastfeeding intervention. In the municipalities, as breastfeeding support takes place for a longer period of time than in hospitals, the four key messages had to be adapted to include relevant information and address challenges that matched the recommended period for exclusive and partial breastfeeding. Literature was consulted to support the decision-making, and external resource persons were involved when needed. During LCM, the intervention contents and materials were developed and tested in a back-and-forth process according to the key principles outlined by O\u0026rsquo;Cathain. This process continued until the group was satisfied with the products (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). During these meetings, researchers also had the opportunity to get important information about the context in which the MBI should be implemented (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). Details about the process and content of LCM are found in Fig.\u0026nbsp;3.\u003c/p\u003e \u003cp\u003eConcurrently with the co-production of the intervention, the developers and evaluators developed a program theory (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) and the evaluators communicated with the health visitors in the working group to ensure an optimal recruitment of trial participants and data collection. Hence, health visitors in the working group acted as important links between the health visitors in each municipality and the developers, along with evaluators, to qualify the processes throughout the entire project as also recommended by MRC (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eTo support the project and the working group during development, implementation and evaluation and ensure broad expertise and competence in decision-making, a reference group was established, representing managers of the health visiting programs in the participating municipalities, representatives from relevant professional associations and representatives from the National Health Authority, the national association of municipalities and Danish Regions, which are responsible for hospitals in Denmark. The reference group met twice a year during the entire project.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStage 3: Prototyping\u003c/h2\u003e \u003cp\u003eA website for parents was tested for functionality by an IT expert and a research colleague; its content and usefulness by parent couples. A theoretical manual of breastfeeding knowledge and intervention activities for health visitors was reviewed by two experts in breastfeeding. The coherent intervention was tested for feasibility in a 2.5-month implementation period in the municipalities after health visitors had received training. The implementation was substantiated by dialogue meetings among the health visitors from the working group and facilitated by the developers. The program theory was finalised to inform the evaluation.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eThe following are the outcomes from the three stages of the development and implementation processes.\u003c/p\u003e\n\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\n \u003ch2\u003eStage 1: Evidence review and stakeholder consultation\u003c/h2\u003e\n \u003cdiv id=\"Sec8\" class=\"Section3\"\u003e\n \u003ch2\u003eNarrative review\u003c/h2\u003e\n \u003cp\u003eThe unpublished narrative review included 32 publications, a report from the Danish National Institute of Public Health and a master thesis from the University of Copenhagen (\u003cspan class=\"CitationRef\"\u003e31\u003c/span\u003e). Most of the studies reported on young mothers, only a few on mothers with no or low educational attainment.\u003c/p\u003e\n \u003cp\u003eFor understanding this group of mothers\u0026rsquo; experiences of the transition to motherhood, we found six qualitative peer-reviewed studies (\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e38\u003c/span\u003e) and one master thesis (\u003cspan class=\"CitationRef\"\u003e39\u003c/span\u003e). Generally, young mothers experience motherhood positively, seeing it as a new chance and a possibility for stability in life. However, they also faced discrimination due to their age and stigmatisation because their maternal competencies were questioned. Some mothers wanted to prove their competence in motherhood, and breastfeeding their baby was an important symbol of that. Stigmatisation was found to impact their confidence, and some mothers rather consulted their network than health professionals if experiencing problems. Generally, mothers found it natural and desirable to breastfeed, but their intention to continue was challenged if breastfeeding after birth was difficult and demanding. Finally, mothers stressed the importance of short, concrete and visual support, and voiced their need for recognition.\u003c/p\u003e\n \u003cp\u003eThe review of effective breastfeeding interventions targeting young mothers and mothers with low educational attainment included seven intervention studies (\u003cspan class=\"CitationRef\"\u003e40\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e46\u003c/span\u003e). They were difficult to summarise due to heterogeneity in content, timing, outcome measures and limited descriptions of the interventions. However, face-to-face interventions and interventions that included multiple elements seemed to positively impact breastfeeding duration. A general call for interventions based on psycho-social theories and interventions involving fathers or other close relations was found as social relations had a strong impact on breastfeeding outcomes.\u003c/p\u003e\n \u003cp\u003eDrawing on four peer-reviewed studies (\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e47\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e49\u003c/span\u003e) and a master thesis (\u003cspan class=\"CitationRef\"\u003e39\u003c/span\u003e), the review underscored the importance of self-efficacy in breastfeeding among the target group. Experiences and attitudes towards breastfeeding in their close network influenced their own confidence in their ability to breastfeed. Moreover, the mothers described how concrete breastfeeding support, confirmation and personal recognition contributed to motivating and maintaining breastfeeding when facing challenges, stressing the importance of targeting self-efficacy in interventions.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n \u003ch2\u003eStakeholder consultation\u003c/h2\u003e\n \u003cp\u003eThe needs assessment was based on interviews with eight mothers and five fathers, observations of seven health visitors\u0026rsquo; home visits, observation of one mother support group with 15 young mothers, and four focus group interviews with 24 health visitors (\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e). All mothers in the interviews and observations had a low educational attainment and six of the eight mothers were younger than 25 years.\u003c/p\u003e\n \u003cp\u003eAlbeit selected to represent mothers in vulnerable positions, the participants experienced considerable differences in their life situations due to differences in degrees of stability in work, economy, cohabitation and mental health; challenges in their maternal role; experiences of stigmatisation; and support from their network. These contextual differences influenced their breastfeeding journey and their breastfeeding self-efficacy, which again emphasised the importance of individual breastfeeding support and a positive, recognising relationship between parents and health professionals. Parents themselves also explicitly underscored the importance of individualised support.\u003c/p\u003e\n \u003cp\u003eDuring pregnancy, all parents wanted their baby to be breastfed. Because they thought breastfeeding would come naturally, parents in general and the fathers in particular saw no need for preparation in pregnancy, which both parents ended up regretting. After birth, most parents were surprised that breastfeeding was not as easy as they had expected and that they faced several practical challenges, like good positioning, timing of breastfeeding and getting the baby to latch on. Understanding the baby\u0026rsquo;s cues was difficult for some mothers, and a crying baby was experienced as a marker for breastfeeding problems and sometimes also as a critique of them as parents. Hence, a thorough, realistic breastfeeding preparation covering the practical challenges was important to include in the intervention.\u003c/p\u003e\n \u003cp\u003eMost parents experienced challenges during breastfeeding, mostly pain and experiences of insufficient milk production. They stressed that their choice of breastfeeding support depended on accessibility, usefulness and attitudes like their own towards breastfeeding. Moreover, many preferred receiving help from their social network. They used the internet to search for assistance and valued short, practical answers and videos. The use of health visitors for assistance depended on the meeting between health visitors and the parents, including the relationship, communication with both parents and the importance of working towards the same goal. Especially the health visitors stressed the importance of visits during pregnancy to initiate the good relation, facilitate a preparation process and involve the fathers. In the MBI, it would be important to include relational and communicative elements. Moreover, it could be important to combine face-to-face support with digital support, which is accessible 24 hours a day.\u003c/p\u003e\n \u003cp\u003eFor many mothers, it took time to establish successful breastfeeding, and the emotional impact of their breastfeeding experiences had a major effect on their breastfeeding self-efficacy. Insecurity about whether the baby got enough milk and about the family\u0026rsquo;s general well-being were essential in all families regardless of the feeding method. Frequent breastfeeding, especially during night, insecurity of whether the baby got enough milk and having time for yourself were arguments for cessation of breastfeeding. On the other hand, a strong motivation and confidence in breastfeeding were driving forces for breastfeeding. None of the mothers who had stopped breastfeeding had asked for support from the health visitors during the decision-making process, which was also the health visitors\u0026rsquo; general experience, causing a great deal of frustration. In the end, all that mattered was that parents were certain that their baby got enough food; whether it was bottle-feeding or breastfeeding was secondary. However, if bottle-feeding was chosen, the mothers retained a big wish to breastfeed their next baby but were also in doubt about their ability to do so. Informed by this needs assessment, the new families might benefit from a self-efficacy-supported intervention with a specific focus on how to assess that the baby was getting enough milk and a proactive approach that might catch early breastfeeding problems before they lead to termination of breastfeeding among mothers wishing to breastfeed.\u003c/p\u003e\n \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e\n \u003ch2\u003eStage 2: Co-production\u003c/h2\u003e\n \u003cp\u003eThe findings from stage 1 and the HBI were the basis for the co-production in the working group, where the intervention was created, including supportive materials such as a dialogue sheet, a pamphlet to assess the infant\u0026rsquo;s thriving, a postcard including the four main messages, a website with text, videos and podcasts, and a manual for health visitors. Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e shows how the needs and attentions were addressed in MBI.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eTable 1. Overview of identified attention points and needs addressed in the Municipality Breastfeeding Intervention.\u003c/strong\u003e\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\n \u003ctable id=\"Tab1\" border=\"1\"\u003e\u003c/table\u003e\n \u003c/div\u003e\n \u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"642\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eIdentified attention points and needs\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAddressed in the Municipality Breastfeeding Intervention\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eAttention towards the feeling of stigma due to age and the need for recognition\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003eCreating a good relationship between health visitor and family, supported by a dialogue sheet introduced during the pregnancy visit.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eRecognition and support tailored to individual needs, wishes and goals of the family using communication based on theory of self-efficacy.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eAttention towards challenged breastfeeding if early breastfeeding was difficult and demanding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003eClose proactive follow-up by health visitors in the first two months following birth.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003ePodcasts with experiences of other parents to increase self-efficacy (vicarious experiences).\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eNeed for short, concrete and visual support\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003ePractical face-to-face support in concrete situations and practical and concrete online videos are needed to provide the family with good experiences to enhance self-efficacy and action competence.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eNeed for the involvement of both parents\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003eOne of the four key messages.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003ePromoting the importance of the father/partner being part of the home visits.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eVideos and podcasts of fathers\u0026rsquo; experiences of his role as a father to a breastfed baby.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eAttention towards the impact of contextual factors, including a close network of the individual parents on breastfeeding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003eIndividual support is based on the parents\u0026rsquo; concrete entire situation.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eUse of a dialogue sheet for the first meeting to support initiating an individual need-based counselling.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eKnowledge about the positive and negative impacts of breastfeeding from the close network.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eNeed for realistic expectations towards breastfeeding during pregnancy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003ePregnancy visits by the health visitor include identifying expectations, wishes and motivation for breastfeeding.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eKnowledge of breastfeeding initiation available online, including breastfeeding experiences provided by other parents.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eNeed for knowledge of practical breastfeeding matters\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003ePractical knowledge of breastfeeding positions, understanding baby\u0026rsquo;s cues, sucking techniques, signs of thriving etc., including instructive videos.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eA pamphlet on assessing if the baby was getting enough milk, what to do if the baby got too little and when to ask for professional help.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eNeed for specific support regarding breastfeeding pain and experiences of insufficient milk production\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003eAn online toolbox was available with concrete, practical proposals to solve pain and experiences of insufficient milk production, including instructive videos.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eNeed for a respectful and appreciative relationship with the health visitor\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003eFocus on establishing a good relationship with the parents.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eAttention towards not asking health visitors for support if breastfeeding is challenging\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003eExplicitly communicate that the health visitor is there to help parents achieve their desired goals.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eCommunicate to the parents what they can use the health visitor for.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eNeed for valid online access to breastfeeding support 24 hours a day\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003eWebsite with evidence-based knowledge on breastfeeding.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.8006230529595%\" valign=\"top\"\u003e\n \u003cp\u003eNeed for access to knowledge of how to bottle-feed the baby\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.19937694704049%\" valign=\"top\"\u003e\n \u003cp\u003ePodcasts on how to bottle-feed the baby and parent\u0026rsquo;s experiences with bottle-feeding.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003cp\u003eIn the adaptation process of the HBI to match the community setting, we identified differences between the two interventions and what to add under each of the four messages. Skin-to-skin contact was proposed to be used much more in the municipalities for creating peace positive relations and solving breastfeeding problems. In the HBI, we emphasised frequent breastfeeding in the initiation period, whereas in the MBI, the focus shifted to needs-based breastfeeding. Breastfeeding positions should be more open for alternative positions than the traditional upright position, and early involvement of the father should be prioritised, preferable in pregnancy.\u003c/p\u003e\n \u003cp\u003eThe communication part was informed by Bandura\u0026rsquo;s theory of self-efficacy, including the four sources to enhance self-efficacy: enactive mastery experiences, vicarious experiences, verbal persuasion and physiological and affective states (\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e). The theory was integrated into all communicative parts of the intervention, from the instructions for the face-to-face support in the manual for health visitors to the texts, videos, and podcasts on the website for parents. The operationalisation of the four sources to enhance self-efficacy is described in Fig.\u0026nbsp;4. Concurrently, health visitors in each municipality revised the digital routine record system to allow for reporting of the intervention activities.\u003c/p\u003e\n \u003cp\u003eThe routine home visit profile of the health visitors is determined by municipal policies (as a local area of government) and therefore varies slightly between the participating municipalities. We found no effective profile in the literature for scheduled home visits. Therefore, the profile for the basic intervention was developed based on the health visitors\u0026rsquo; experiences and knowledge about when potential breastfeeding problems might arise in the families. In most of the municipalities, a home visit was offered when the baby was 4 months old. During this visit, families were guided to introduce complementary foods to the baby. Our hypothesis was that this visit might arouse parents\u0026rsquo; curiosity and stimulate them to introduce complementary food for the baby before intended, thereby shortening the exclusive breastfeeding duration. Thus, in the intervention, the 4-month visit was substituted by a 4-month telephone call during which the health visitor and the family would plan a home visit for the introduction of complementary food according to the individual family\u0026rsquo;s breastfeeding process and needs. The final profile of the home visits and telephone calls are shown in Supplementary Table\u0026nbsp;2.\u003c/p\u003e\n \u003cp\u003eFor the intensified intervention, we wanted to enhance needs-based communication by enabling more frequent contact between the families and the health visitors. The purpose of this was to identify early breastfeeding challenges, support with problem-solving and thereby address the identified problem in stage 1 of mothers not reaching out to the health visitor when needing support. Therefore, we decided that the intensified intervention should consist of scheduled proactive calls. Inspiration was found in a Danish study where proactive telephone calls were found to enhance exclusive breastfeeding at 3 months with a factor 2.5 in a group of overweight/obese mothers (\u003cspan class=\"CitationRef\"\u003e50\u003c/span\u003e). Hence, the intensified intervention offered a higher dose of the intervention based on the same breastfeeding principles as in the basic intervention. It was a balancing act to ensure consistency between health visitors\u0026rsquo; support and offer an individual approach. We made supportive guidelines for all visits and telephone calls (not to be followed slavishly). To stimulate an individual approach, we designed the initiation of the visit to be an open question to the family about their general well-being, how breastfeeding was going and if anything worried them. The final profile of home visits was approved by the managers of the health visiting program.\u003c/p\u003e\n \u003cp\u003eIn addressing social inequity in breastfeeding during the development process, we constantly strove to find a balance between reaching the group of young mothers and mothers with low educational attainment and not labelling and stigmatising them. In stage one, we identified the importance of a good relationship built on trust and a sense of security between the mothers in this group and the health visitors to address this issue.\u003c/p\u003e\n \u003cp\u003eTo enable the health visitors to engage in tailored and individualised support to the families, we developed a communication tool aiming to open a conversation about the families\u0026rsquo; unique needs and goals for breastfeeding. The tool underwent a complicated back and forward adaptation process. Initially, we proposed a mind-mapping technique, which was introduced at an LCM and tested in role-play exercises. However, after testing it out with families, the health visitors found it too demanding for this project. We opted for a simpler tool, entitled the dialogue sheet, where the health visitor and the family in a joint process were supposed to identify the unique needs and wishes based on icons of essential elements of importance to breastfeeding. The dialogue sheet should optimally be introduced at the pregnancy visit or alternatively at the first home visit after birth.\u003c/p\u003e\n \u003cp\u003eIn stage 1, both parents and health visitors proposed a website with simple, practical, evidence-based knowledge about breastfeeding and instructive videos that were available when needed 24/7. Based on the needs in stage 1, we presented and agreed on a frame for the web app with nine topics at the LCM. The web app had three layers, which accommodated different levels of knowledge among users, and the four key messages were the foundation of all information. Fifteen practical videos were produced with voice-over, explaining and describing what the videos were showing and thereby focused on vicarious experiences as a source to increase self-efficacy. The topics of the videos were, among others, breastfeeding positions, baby\u0026rsquo;s feeding cues, sucking technique and preparing for breastfeeding in pregnancy. Eight podcasts were produced to provide parents with experiences and tips from other parents with among others breastfeeding initiation and how partners supported the breastfeeding mothers. The topic \u0026lsquo;preparing for breastfeeding\u0026rsquo; included a quiz, where parents could compete on knowledge and myths about breastfeeding to stimulate their interest in breastfeeding during pregnancy and contribute to providing a realistic perspective on breastfeeding. Finally, the web app included a toolbox of proposals for solving the two main problems causing early cessation of breastfeeding: pain and perceived insufficient milk.\u003c/p\u003e\n \u003cp\u003eOther materials produced during stage 2 were a postcard with the four key messages, a link to the web app, and a pamphlet to support parents considering whether their baby got enough milk, including information on a minimum number of daily breastfeedings, normal stool and urination, feeding cues, other signs of well-being, a \u0026lsquo;what to do guide\u0026rsquo; if things were not as described, and when to contact health professionals for more assistance. A similar pamphlet had earlier been used in one region in Denmark. The pamphlet was valued by parents and health professionals because it provided parents with the competence to act and self-efficacy when insecure about their baby\u0026rsquo;s thriving. The pamphlet was updated according to evidence and redesigned to fit the other materials of the MBI. All materials were produced in Danish and English versions, including the web app and all the videos.\u003c/p\u003e\n \u003cp\u003eA new intervention training program was developed based on the HBI but adapted to the families\u0026rsquo; post-discharge needs and the health visitors\u0026rsquo; needs. A draft of a program was presented and discussed at the LCM. When the municipalities agreed to participate in the project, they signed a document permitting all health visitors to participate in a course encompassing three hours of e-learning and a subsequent two-day training course. The theoretical e-learning preceding the training course gave us the possibility to include more interactive learning in the course, such as discussions, reflections, exercises and role-plays to enhance the health nurses\u0026rsquo; self-efficacy and action competency to deliver the intervention, as also recommended in previous interventions (\u003cspan class=\"CitationRef\"\u003e51\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e52\u003c/span\u003e). The final program of the e-learning consisted of theoretical input about the anatomy and physiology of breastfeeding, skin-to-skin contact, self-efficacy and an introduction to the dialogue sheet. The two-day training course covered the following topics: Breastfeeding \u0026ndash; a joint parental task, the social context of breastfeeding and its impact on breastfeeding, preparing for breastfeeding, the relation between health visitor and parents, breastfeeding positions and suckling technique, breastfeeding on demand, pain and sore nipples, how to tailor support to the individual family, and enhancing self-efficacy in practice. The intervention material was activated during the training. A detailed program theory for the training program and evaluation of effectiveness on health visitors\u0026rsquo; breastfeeding knowledge, self-efficacy and action competence is described elsewhere (\u003cspan class=\"CitationRef\"\u003e53\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eThe entire breastfeeding intervention was mapped in a program theory, including activities, mechanisms, output, outcomes, impact and context for both target groups. See Fig. \u003cspan class=\"InternalRef\"\u003e5\u003c/span\u003ea and \u003cspan class=\"InternalRef\"\u003e5\u003c/span\u003eb.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003eStage 3: Prototyping\u003c/h2\u003e\n \u003cp\u003eMost of the pilot testing was performed during the co-production phase as described earlier. Feedback from the health visitors\u0026rsquo; testing and discussions with colleagues in the LCM gave rise to several changes, such as the dialogue sheet mentioned above. Other material was tested in families and found useful, such as the pamphlet to support parents\u0026rsquo; assessment of the baby\u0026rsquo;s thriving. The review of the manual (\u003cspan class=\"CitationRef\"\u003e53\u003c/span\u003e) by two breastfeeding experts gave rise to small adjustments.\u003c/p\u003e\n \u003cp\u003eThe web-app was carefully tested by experts to identify potential dead ends and ensure that links were working as intended. Five parent couples were asked to assess the content for usefulness and relevance. Consequently, the quiz was divided into three parts as it was found too long for a single session.\u003c/p\u003e\n \u003cp\u003eA pilot test of \u0026lsquo;Breastfeeding \u0026ndash; a good start together\u0026rsquo; was conducted after all health visitors in the 10 intervention municipalities had completed the training course. During the 2.5-month implementation period health visitors implemented the intervention in the families. Tips and challenges were collected and solved at dialogue meetings in the working group, and the intervention was revised accordingly. Especially practical problems with the web-app were identified as were also challenges implementing the dialogue sheet in the initial home visits after birth. Hence, we decided that the dialogue sheet should be used in the families only during pregnancy visits when undisturbed dialogue is more feasible. This decision was made to address the challenges of engaging in such discussions after birth when families are adjusting to life with a newborn.\u003c/p\u003e\n \u003cp\u003eAfter the final approval by the health visitors, the MBI was ready for evaluation.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study contributes to the evidence on how to optimize breastfeeding support to new families after discharge from maternity hospital in general and young mothers and mothers with low educational attainment in particular. Moreover, it contributes with insights into the development of a complex public health intervention by testing Hawking\u0026rsquo;s three-stage framework including 1) evidence review and stakeholder consultation 2) co-production and 3) prototyping (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e), informed by O\u0026rsquo;Cathain\u0026rsquo;s five key working principles and ten key actions for development (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). We hereby make our experiences available, including strengths and weaknesses of the co-production approach, experiences with prototyping and considerations of developers\u0026rsquo; positioning.\u003c/p\u003e \u003cp\u003eStrength and weaknesses of the framework and working principles\u003c/p\u003e \u003cp\u003eFollowing Hawkin\u0026rsquo;s three-stage framework and O\u0026rsquo;Cathain\u0026rsquo;s working principles was crucial for tailoring the intervention content to the target group and the setting during the design stage. While this process was time-consuming, it proved very valuable. The working principles suggest an iterative, creative and open-minded process. We followed these principles and found them especially valuable for the intervention when considering the inclusion of a digital solution and for developing an instrument for supporting a tailored and individual approach (dialogue sheet). The democratic and joint learning back-and-forth processes between developers and health visitors in the working group took time. Having a time schedule with space for unforeseen issues was therefore paramount. However, this approach also assumes strict time management as it would be tempting to keep on working to get the optimal solution, an experience shared by other developers of complex interventions (\u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e54\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe framework and the working principles also suggested a co-creation approach. In this study, we involved health visitors from the participating municipalities during all three stages. Parents were involved in stage one (stakeholder consultation) and stage three (intervention prototyping). The development process might have benefitted even more if parents had been involved in the entire process, bringing their opinions into the discussions. A process evaluation, which is about to be published, has shown that the dialogue sheet was not adopted in its entirety by the health visitors, although it was valued especially by the fathers. Thus, further testing during the development stage could have been warranted. Bringing the two target groups together might have been beneficial for discussing the usefulness and the final production of the instrument. This collaboration would have been an important step in targeting breastfeeding support to the families\u0026rsquo; unique needs.\u003c/p\u003e \u003cp\u003eAmong health visitors, the co-creation process resulted in great engagement and ownership of the intervention, which was a driving force during its implementation. A prerequisite for the municipalities\u0026rsquo; involvement of health visitors from practice was reimbursement for the time spent during the development phase. Therefore, the budget for the entire research project must include payment to the municipalities to ensure that involvement in the project does not negatively impact the support offered to families during this period.\u003c/p\u003e \u003cp\u003eDevelopers\u0026rsquo; positioning\u003c/p\u003e \u003cp\u003eThe two developers\u0026rsquo; central positioning in the breastfeeding landscape in Denmark may have played a positive and important role during the development of the intervention. Being advisors to the National Board of Health, the authors of the national recommendations, breastfeeding trainers of health visitors in Denmark and having a good insight into health visitors\u0026rsquo; field of work have possibly positively influenced the development of the new intervention and facilitated its subsequent implementation. However, it might also have introduced bias into the process due to blind spots or an uneven perception of breastfeeding authority, potentially causing the visiting nurses to withhold ideas and perspectives.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis comprehensive description of the development of a complex intervention based on the framework of Hawkin and O\u0026rsquo;Cathain is an example of how to co-produce and prototype a breastfeeding intervention aimed to increase the duration and reduce inequity in breastfeeding in collaboration with parents and health professionals. We illuminate how the needs and attentions identified in stage 1 are processed and addressed in the intervention and how the intervention is tested and adapted to the specific context during stages 2 and 3. This project partly mitigates the limited guidance and research on the development stage. The description provides breastfeeding practitioners and researchers with a transparent foundation for the ongoing qualification of breastfeeding support and methodology on complex intervention development.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eHBI = Hospital-Based Intervention\u003c/p\u003e\n\u003cp\u003eLCM = Learning Cycle Meeting\u003c/p\u003e\n\u003cp\u003eMBI = Municipality Based Intervention\u003c/p\u003e\n\u003cp\u003eMRC = Medical Research Counsil\u003c/p\u003e\n\u003cp\u003eSEP = Socio-economic position\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate\u003c/p\u003e\n\u003cp\u003eAccording to the Helsinki Declaration, all participants were informed about the study both verbally and in writing. Informed written consent to collect and safely store data and publish results of the study was obtained. Hence, participant information and data protection comply with the General Data Protection Regulation (GDPR). As this study is not a trial and does not include human tissues, ethics approval is not required by Danish law.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Availability of data and materials\u003c/p\u003e\n\u003cp\u003eThe data used for stage 1 are available from the first author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Competing interests\u003c/p\u003e\n\u003cp\u003eThe authors declare that the funding\u0026nbsp;interests\u0026nbsp;may be considered as potential competing interests\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Funding\u003c/p\u003e\n\u003cp\u003eThis study was supported by NordeaFonden (grant number 02-2019-00267) and Det Obelske Familiefond (grant number 29763). The funding sources had no influence of the study during the entire process from idea to decision to submit the article for publication.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Authors contribution\u003c/p\u003e\n\u003cp\u003eIN, MBR and SFV have made substantial contributions to the conception of the research, the design of the work, the acquisition, and the interpretation of data. IN has drafted the work and SFV and IN has substantively revised it. IN, MBR and SFV have approved the submitted version and agreed both to be personally accountable for the author\u0026apos;s own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Acknowledgments\u003c/p\u003e\n\u003cp\u003eFirst and foremost, the authors thank mothers, fathers and health visitors for participating in the study. Likewise, we thank Anne Oehlers for her assistance during the focus-group interviews and the subsequent transcriptions.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWHO. Global strategy for infant and young child feeding. World Health Organization; 2003. \u003c/li\u003e\n\u003cli\u003eVictora CG, Bahl R, Barros AJ, Fran\u0026ccedil;a GV, Horton S, Krasevec J, m.fl. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. The Lancet. 2016;387(10017):475\u0026ndash;90. \u003c/li\u003e\n\u003cli\u003eP\u0026eacute;rez-Escamilla R, Tomori C, Hern\u0026aacute;ndez-Cordero S, Baker P, Barros AJD, B\u0026eacute;gin F, m.fl. Breastfeeding: crucially important, but increasingly challenged in a market-driven world. The Lancet. February 2023;401(10375):472\u0026ndash;85. \u003c/li\u003e\n\u003cli\u003eBruun S, Wedderkopp N, M\u0026oslash;lgaard C, Kyhl HB, Zachariassen G, Husby S. Using text messaging to obtain weekly data on infant feeding in a Danish birth cohort resulted in high participation rates. Acta Paediatr. June 2016;105(6):648\u0026ndash;54. \u003c/li\u003e\n\u003cli\u003eSundhedsdatastyrelsen, Denmark [Internet]. 2022. The National Children\u0026rsquo;s Database. Tilg\u0026aelig;ngelig hos: https://www.esundhed.dk/Registre/Den-nationale-boernedatabase/Foerste-leveaar\u003c/li\u003e\n\u003cli\u003eB\u0026aelig;rug A, Laake P, L\u0026oslash;land BF, Tyllesk\u0026auml;r T, Tufte E, Fretheim A. Explaining socioeconomic inequalities in exclusive breast feeding in Norway. Arch Dis Child. February 2017;archdischild-2016-312038. \u003c/li\u003e\n\u003cli\u003eIbanez G, Martin N, Denantes M, Saurel-Cubizolles MJ, Ringa V, Magnier AM. Prevalence of breastfeeding in industrialized countries. Rev D\u0026Eacute;pid\u0026eacute;miologie Sant\u0026eacute; Publique. August 2012;60(4):305\u0026ndash;20. \u003c/li\u003e\n\u003cli\u003eJohansen A, Krogh C, Weber Pant S, Holstein BE. Amning: Temarapport og \u0026aring;rsrapport. B\u0026oslash;rn f\u0026oslash;dt i 2014. K\u0026oslash;benhavn: Databasen B\u0026oslash;rns Sundhed og Statens Institut for Folkesundhed, SDU.; 2016. \u003c/li\u003e\n\u003cli\u003eSacker A, Kelly Y, Iacovou M, Cable N, Bartley M. Breast feeding and intergenerational social mobility: what are the mechanisms? Arch Dis Child. September 2013;98(9):666\u0026ndash;71. \u003c/li\u003e\n\u003cli\u003eVictora CG, Horta BL, de Mola CL, Quevedo L, Pinheiro RT, Gigante DP, m.fl. Association between breastfeeding and intelligence, educational attainment, and income at 30 years of age: a prospective birth cohort study from Brazil. Lancet Glob Health. April 2015;3(4):e199\u0026ndash;205. \u003c/li\u003e\n\u003cli\u003eKronborg H, Foverskov E. Multifactorial influence on duration of exclusive breastfeeding; a Danish cohort study. Yourkavitch J, redakt\u0026oslash;r. PLOS ONE. September 2020;15(9):e0238363. \u003c/li\u003e\n\u003cli\u003eMcFadden A, Gavine A, Renfrew MJ, Wade A, Buchanan P, Taylor JL, m.fl. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Pregnancy and Childbirth Group, redakt\u0026oslash;r. Cochrane Database Syst Rev [Internet]. February 2017 http://doi.wiley.com/10.1002/14651858.CD001141.pub5\u003c/li\u003e\n\u003cli\u003eDykes F, Moran VH, Burt S, Edwards J. Adolescent Mothers and Breastfeeding: Experiences and Support Needs\u0026mdash;An Exploratory Study. J Hum Lact. January 2003;19(4):391\u0026ndash;401. \u003c/li\u003e\n\u003cli\u003eEntwistle F, Kendall S, Mead M. Breastfeeding support - the importance of self-efficacy for low-income women. Matern Child Nutr [Internet]. september 2009. http://doi.wiley.com/10.1111/j.1740-8709.2009.00202.x\u003c/li\u003e\n\u003cli\u003eHunter L, Magill-Cuerden J, McCourt C. Disempowered, passive and isolated: how teenage mothers\u0026rsquo; postnatal inpatient experiences in the UK impact on the initiation and continuation of breastfeeding: Postnatal inpatient experiences and breastfeeding. Matern Child Nutr. January 2015;11(1):47\u0026ndash;58. \u003c/li\u003e\n\u003cli\u003eNilsson I, Busck-Rasmussen M, Rossau HK, Villadsen SF. Breastfeeding trajectories of young and short-term educated mothers and their partners; experiences of a journey facing tailwind and headwind. Midwifery. October 2022;113:103436. \u003c/li\u003e\n\u003cli\u003eSheeran N, Jones L, Rowe J. Joys and challenges of motherhood for Australian young women of preterm and full-term infants: an Interpretative Phenomenological Analysis. J Reprod Infant Psychol. October 2015;33(5):512\u0026ndash;27. \u003c/li\u003e\n\u003cli\u003eKronborg H, V\u0026aelig;th M, Olsen J, Iversen L, Harder I. Effect of early postnatal breastfeeding support: a cluster-randomized community based trial. Acta Paediatr. 2007;96(7):1064\u0026ndash;70. \u003c/li\u003e\n\u003cli\u003eNilsson I, Strandberg-Larsen K, Knight CH, Hansen AV, Kronborg H. Focused breastfeeding counselling improves short- and long-term success in an early-discharge setting: A cluster-randomized study. Matern Child Nutr. 2017;13(4):e12432. \u003c/li\u003e\n\u003cli\u003eSkivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, m.fl. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. September 2021;n2061. \u003c/li\u003e\n\u003cli\u003eHawkins J, Madden K, Fletcher A, Midgley L, Grant A, Cox G, m.fl. Development of a framework for the co-production and prototyping of public health interventions. BMC Public Health. September 2017;17(1):689. \u003c/li\u003e\n\u003cli\u003eO\u0026rsquo;Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, m.fl. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. August 2019;9(8):e029954. \u003c/li\u003e\n\u003cli\u003eRossau HK, Nilsson IMS, Busck-Rasmussen M, Ekstr\u0026oslash;m CT, Gadeberg AK, Hirani JC, m.fl. Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial. BMC Public Health. March 2023;23(1):450. \u003c/li\u003e\n\u003cli\u003eSundhedsstyrelsen (Danish Health and Medicines Authority). Sundhedsstyrelsens anbefalinger for svangreomsorgen. 2021. \u003c/li\u003e\n\u003cli\u003eCraig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. September 2008;a1655. \u003c/li\u003e\n\u003cli\u003eCraig P, Di Ruggiero E, Frohlich KL, Mykhalovskiy E, White M, on behalf of the Canadian Institutes of Health Research (CIHR)\u0026ndash;National Institute for Health Research (NIHR) Context Guidance Authors Group (listed alphabetically), m.fl. Taking account of context in population health intervention research: guidance for producers, users and funders of research. 2018 Apr https://www.journalslibrary.nihr.ac.uk/nihr-research/canadian-institutes-of-health-research-cihr-and-nihr-collaboration.htm\u003c/li\u003e\n\u003cli\u003eDuncan E, O\u0026rsquo;Cathain A, Rousseau N, Croot L, Sworn K, Turner KM, m.fl. Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study. BMJ Open. April 2020;10(4):e033516. \u003c/li\u003e\n\u003cli\u003eBandura, Albert. Self-Efficacy: The Exercise of Control. 1st edition. New York: Worth Publishers; 1997. 604 s. \u003c/li\u003e\n\u003cli\u003eKreuter MW, Bull FC, Clark EM, Oswald DL. Understanding how people process health information: A comparison of tailored and nontailored weight-loss materials. Health Psychol. September 1999;18(5):487\u0026ndash;94. \u003c/li\u003e\n\u003cli\u003eGreen B, Johnson C, Adams A. Writing narrative literature reviews for peer-reviewed journals: secrets of the trade. J Chiropr Med. 2006;5(3):101\u0026ndash;7. \u003c/li\u003e\n\u003cli\u003e\u0026Oslash;hlers, A, Nilsson, I I. [Breastfeeding among young and short-educated mothers. A narrative literature review] Amning blandt unge og kortuddannede m\u0026oslash;dre. Et narrativt litteraturstudie. [Internet]. Copenhagen, Denmark: Danish Committee for Health Education; 2021. Online: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/http://www.kompetencecenterforamning.dk/media/193570/amning_blandt_unge_febr2021.pdf\u003c/li\u003e\n\u003cli\u003eMalterud K. Systematic text condensation: A strategy for qualitative analysis. Scand J Public Health. December 2012;40(8):795\u0026ndash;805. \u003c/li\u003e\n\u003cli\u003eDuus, G, Husted, M, Kildedal, K, Laursen, E, Tofteng, D. Aktionsforskning - en grundbog. 1. edition. Bd. 2014. Samfundslitteratur; 2014. \u003c/li\u003e\n\u003cli\u003eLauttam\u0026auml;ki V. ACTVOD-futures workshop \u0026ndash; a generic structure for a one-day futures workshop. Foresight J Futur Stud Strateg Think Policy. 2016;18(2):156\u0026ndash;71. \u003c/li\u003e\n\u003cli\u003eErfina E, Widyawati W, McKenna L, Reisenhofer S, Ismail D. Adolescent mothers\u0026rsquo; experiences of the transition to motherhood: An integrative review. Int J Nurs Sci. April 2019;6(2):221\u0026ndash;8. \u003c/li\u003e\n\u003cli\u003eHunter L, Magill-Cuerden J. Young mothers\u0026rsquo; decisions to initiate and continue breastfeeding in the UK: tensions inherent in the paradox between being, but not being able to be seen to be, a good mother. Evid Based Midwifery. 2014;12(2):46\u0026ndash;51. \u003c/li\u003e\n\u003cli\u003eNoble-Carr D, Bell C. Exposed: younger mothers and breastfeeding. Breastfeed Rev Prof Publ Nurs Mothers Assoc Aust. November 2012;20(3):27\u0026ndash;38. \u003c/li\u003e\n\u003cli\u003eWahn EH, Nissen E, Ahlberg BM. Becoming and Being a Teenage Mother: How Teenage Girls in South Western Sweden View Their Situation. Health Care Women Int. August 2005;26(7):591\u0026ndash;603. \u003c/li\u003e\n\u003cli\u003eRasmussen JS. Unge f\u0026oslash;rstegangsm\u0026oslash;dres oplevelse af ammeforl\u0026oslash;bet med fokus p\u0026aring; beslutningstagen [Kandidatuddannelsen i Jordemodervidenskab]. Syddansk Universitet; 2018. \u003c/li\u003e\n\u003cli\u003eKaunonen M, Hannula L, Tarkka MT. A systematic review of peer support interventions for breastfeeding: \u003cem\u003eSupport for breastfeeding\u003c/em\u003e. J Clin Nurs. July 2012;21(13\u0026ndash;14):1943\u0026ndash;54. \u003c/li\u003e\n\u003cli\u003eMeglio GD, McDermott MP, Klein JD. A Randomized Controlled Trial of Telephone Peer Support\u0026rsquo;s Influence on Breastfeeding Duration in Adolescent Mothers. Breastfeed Med. February 2010;5(1):41\u0026ndash;7. \u003c/li\u003e\n\u003cli\u003eMejdoubi J, van den Heijkant SCCM, van Leerdam FJM, Crone M, Crijnen A, HiraSing RA. Effects of nurse home visitation on cigarette smoking, pregnancy outcomes and breastfeeding: A randomized controlled trial. Midwifery. June 2014;30(6):688\u0026ndash;95. \u003c/li\u003e\n\u003cli\u003ePugh LC, Milligan RA, Frick KD, Spatz D, Bronner Y. Breastfeeding Duration, Costs, and Benefits of a Support Program for Low-Income Breastfeeding Women. Birth. June 2002;29(2):95\u0026ndash;100. \u003c/li\u003e\n\u003cli\u003eSrinivas GL, Benson M, Worley S, Schulte E. A Clinic-Based Breastfeeding Peer Counselor Intervention in an Urban, Low-Income Population: Interaction with Breastfeeding Attitude. J Hum Lact. February 2015;31(1):120\u0026ndash;8. \u003c/li\u003e\n\u003cli\u003eVolpe EM, Bear M. Enhancing Breastfeeding Initiation in Adolescent Mothers Through the Breastfeeding Educated and Supported Teen (BEST) Club. J Hum Lact. August 2000;16(3):196\u0026ndash;200. \u003c/li\u003e\n\u003cli\u003eWambach KA, Aaronson L, Breedlove G, Domian EW, Rojjanasrirat W, Yeh HW. A Randomized Controlled Trial of Breastfeeding Support and Education for Adolescent Mothers. West J Nurs Res. June 2011;33(4):486\u0026ndash;505. \u003c/li\u003e\n\u003cli\u003eBailey J, Clark M, Shepherd R. Duration of breastfeeding in young women: psychological influences. Br J Midwifery. March 2008;16(3):172\u0026ndash;8. \u003c/li\u003e\n\u003cli\u003eMossman M, Heaman M, Dennis CL, Morris M. The Influence of Adolescent Mothers\u0026rsquo; Breastfeeding Confidence and Attitudes on Breastfeeding Initiation and Duration. J Hum Lact. January 2008;24(3):268\u0026ndash;77. \u003c/li\u003e\n\u003cli\u003eNilsson IMS, Kronborg H, Rahbek K, Strandberg‐Larsen K. The significance of early breastfeeding experiences on breastfeeding self‐efficacy one week postpartum. Matern Child Nutr. July 2020. https://onlinelibrary.wiley.com/doi/abs/10.1111/mcn.12986\u003c/li\u003e\n\u003cli\u003eCarlsen EM, Kyhnaeb A, Renault KM, Cortes D, Michaelsen KF, Pryds O. Telephone-based support prolongs breastfeeding duration in obese women: a randomized trial. Am J Clin Nutr. November 2013;98(5):1226\u0026ndash;32. \u003c/li\u003e\n\u003cli\u003eDykes F. The education of health practitioners supporting breastfeeding women: time for critical reflection. Matern Child Nutr. October 2006;2(4):204\u0026ndash;16. \u003c/li\u003e\n\u003cli\u003eKronborg H, Vaeth M, Olsen J, Harder I. Health visitors and breastfeeding support: influence of knowledge and self-efficacy. Eur J Public Health. February 2008;18(3):283\u0026ndash;8. \u003c/li\u003e\n\u003cli\u003eRossau HK, Nilsson I, Villadsen SF. Strengthening health visitors\u0026rsquo; breastfeeding support - results from a cluster randomised study. Nurse Education in Practice. 2024;78(July 2024). \u003c/li\u003e\n\u003cli\u003eMaindal HT, Timm A, Dahl-Petersen IK, Davidsen E, Hillersdal L, Jensen NH, m.fl. Systematically developing a family-based health promotion intervention for women with prior gestational diabetes based on evidence, theory and co-production: the Face-it study. BMC Public Health. December 2021;21(1):1616. \u003c/li\u003e\n\u003c/ol\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":"archives-of-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"aoph","sideBox":"Learn more about [Archives of Public Health](http://archpublichealth.biomedcentral.com/)","snPcode":"13690","submissionUrl":"https://submission.nature.com/new-submission/13690/3","title":"Archives of Public Health","twitterHandle":"@Archpubhealth","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Breastfeeding, complex intervention, development, municipality, inequity, co-production, action research, health visitor, young mothers, social inequality","lastPublishedDoi":"10.21203/rs.3.rs-4662366/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4662366/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBreastfeeding is the ideal nutrition for infants and protects infants and mothers from a range of adverse health outcomes during their lifespan. In Denmark, while the breastfeeding initiation rate is high, only 14% of mothers meet the World Health Organization’s recommendation of exclusive breastfeeding at six months. Furthermore, a notable social inequity exists among those who achieve this recommendation. Knowledge of effective interventions to reduce breastfeeding inequity is limited. A previous hospital-based intervention succeeded in increasing breastfeeding duration. However, most breastfeeding support is provided in Danish municipalities by health visitors. This called for adapting the intervention to the health visiting program and developing an intensified intervention addressing the social inequity in breastfeeding. This article describes the adaptation and development process of the intervention ‘Breastfeeding – a good start together’.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDuring a 15-month period in 2020-21, the municipal intervention was iteratively developed using a three-stage framework for developing complex health interventions described by Hawkins et al. The three stages were 1) need assessment and stakeholder consultation, 2) co-production and 3) prototyping. The process was inspired by O’Cathain et al.’s principles for a user-centred, co-created and theory- and evidence-based approach, involving parents and health visitors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn stage 1, we identified the needs and priorities of the target groups of the intervention. In stage 2, the intervention was developed through action research design and inspired by Duus’ ‘learning cycles’ as the method to enhance motivation and ownership and to strengthen the implementation process by creating a joint room for learning and reflection with health visitors and developers. In stage 3, the intervention was tested for feasibility and usefulness during a 2.5-month period accompanied by monthly dialogue meetings with health visitors and developers. In this period, the intervention was refined based on the gathered experiences and was subsequently prepared for evaluation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe description of the development of this complex intervention, aimed at increasing breastfeeding duration and reducing inequity, offers breastfeeding practitioners and researchers a transparent foundation for continuously improving breastfeeding support and a methodology for complex intervention development.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRegistered at Clinical Trials NCT05311631.\u003c/p\u003e","manuscriptTitle":"Development of a complex intervention to strengthen municipality-based breastfeeding support to reduced social inequity in breastfeeding","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-09 14:26:02","doi":"10.21203/rs.3.rs-4662366/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-09-02T08:54:21+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-08-28T10:30:51+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-08-26T15:19:47+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"15878674747071579744150320943883444524","date":"2024-08-20T15:13:21+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"189679848050121547526434766110212223380","date":"2024-08-20T13:07:12+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"57426612052711430671090753286171306949","date":"2024-08-19T06:53:56+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-08-12T19:08:23+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"213447212256304947409791995191218031949","date":"2024-08-12T16:12:51+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-08-12T15:36:59+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-07-05T05:48:45+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-07-05T05:47:44+00:00","index":"","fulltext":""},{"type":"submitted","content":"Archives of Public Health","date":"2024-06-30T10:50:17+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"archives-of-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"aoph","sideBox":"Learn more about [Archives of Public Health](http://archpublichealth.biomedcentral.com/)","snPcode":"13690","submissionUrl":"https://submission.nature.com/new-submission/13690/3","title":"Archives of Public Health","twitterHandle":"@Archpubhealth","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5535ea66-68cc-40b5-8b4c-25974d6200fc","owner":[],"postedDate":"August 9th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-10-07T16:10:25+00:00","versionOfRecord":{"articleIdentity":"rs-4662366","link":"https://doi.org/10.1186/s13690-024-01401-6","journal":{"identity":"archives-of-public-health","isVorOnly":false,"title":"Archives of Public Health"},"publishedOn":"2024-10-02 15:57:34","publishedOnDateReadable":"October 2nd, 2024"},"versionCreatedAt":"2024-08-09 14:26:02","video":"","vorDoi":"10.1186/s13690-024-01401-6","vorDoiUrl":"https://doi.org/10.1186/s13690-024-01401-6","workflowStages":[]},"version":"v1","identity":"rs-4662366","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4662366","identity":"rs-4662366","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}