Effect Of Theory-Based Health Education Intervention In Improving Exclusive Breastfeeding Intention Among Working Mothers: A Study Protocol For A Cluster Randomised Controlled Trial

Effect Of Theory-Based Health Education Intervention In Improving Exclusive Breastfeeding Intention Among Working Mothers: A Study Protocol For A Cluster Randomised Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Effect Of Theory-Based Health Education Intervention In Improving Exclusive Breastfeeding Intention Among Working Mothers: A Study Protocol For A Cluster Randomised Controlled Trial Khadijahtul Qubra Amizah Hamzah, Nor Afiah Mohd Zulkefli, Norliza Ahmad, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7153570/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Background Breastfeeding is crucial for a child’s health, providing numerous benefits such as improved disease resistance and intelligence. Despite global efforts, exclusive breastfeeding rates remain a concern. Maternal employment is a well-documented, significant barrier, as working mothers often face challenges in sustaining exclusive breastfeeding. Studies have shown that prenatal intention strongly influences breastfeeding practices. Thus, an intervention module in improving exclusive breastfeeding intention targeting knowledge, attitude, subjective norm, and perceived control is necessary. This study aims to develop, validate, and evaluate a theory-based intervention programme to improve exclusive breastfeeding intention among working mothers in Malacca, Malaysia. This randomised controlled trial, guided by CONSORT, will assess the intervention's impact on knowledge, attitude, subjective norm, perceived control, and exclusive breastfeeding intention among working mothers. Methods This two-arm randomised controlled trial will allocate pregnant women to either the intervention or control group by cluster, with each cluster defined as a government health clinic. This study will be conducted over a 30-month period, encompassing planning, theory-based module development, implementation, and effectiveness evaluation. All pregnant women who meet the inclusion criteria will be included. A total of 216 participants are needed for hypothesis testing. Participants will be randomly allocated into two parallel groups at a 1:1 ratio (n=108 per group) to receive either the health education intervention or standard routine care. The primary outcome is exclusive breastfeeding intention, and the secondary outcomes are knowledge, attitude, subjective norms, and perceived behaviour control regarding exclusive breastfeeding, which will be measured at baseline, 1 month, and 4 months postnatal. Discussion This study is the first trial to assess the effectiveness of a theory-based health education intervention in improving exclusive breastfeeding intention among working mothers in Malaysia. Furthermore, this study will provide evidence on the effectiveness of the intervention delivered throughout both the antenatal and postnatal periods within this region. Ethics and dissemination This study protocol was approved by the Medical Research and Ethics Committee Ministry of Health Malaysia (NMRR ID-24-02852-NQU (IIR) on 23 rd December 2024. Trial registration Thai Clinical Trials Registry, TCTR20250116001. Registered on 16 th January, 2025. Exclusive breastfeeding intention working mothers randomised control trial intervention health education Figures Figure 1 Background Breastfeeding is vital for a child’s survival and health. Breast milk is a safe, natural, and sustainable food, considered the most complete nutritional source for infants ( 1 ). It contains immunological factors necessary for infants to thrive and resist many common childhood infections and severe diseases such as diarrhoea and respiratory illnesses. Furthermore, it possesses the highest life-saving potential, preventing half a million infant deaths and 13% of child deaths globally ( 2 – 4 ). Breastfed children tend to perform better on intelligence tests and are less likely to be overweight or obese later in life ( 4 ). Women who breastfeed also benefit personally from the practice, as it can reduce their risk of certain cancers and Type II diabetes ( 2 , 4 ). Both the United Nations Children’s Fund (UNICEF) and WHO recommend that infants begin breastfeeding within the first hour of life, are exclusively breastfed for the first six months, and continue breastfeeding until at least two years of age ( 5 ). Exclusive breastfeeding (EBF) is defined as “when an infant receives only breast milk and no other liquids or solids, including water, with the exception of prescribed vitamins, minerals or medicines” ( 6 ). This breastfeeding practice is the most effective global public health intervention in ensuring optimal health and development in infants ( 5 ). Despite awareness efforts by various governments and non-governmental organisations on the benefits of EBF, the prevalence of adequate breastfeeding practice remains a global concern ( 7 ). Globally, only 43.5% of infants were exclusively breastfed in 2019, a mere ten-percentage-point increment from the 34.0% reported in 1990 ( 8 ). EBF was highest in Latin America (59.7%), followed by Oceania (56.8%), and South Asia (53.9%) ( 8 ). However, many countries are not on track to meet the WHO Global Nutrition Target of at least 50% EBF infants under six months by 2025 and 70% by 2030 ( 9 ). The prevalence of EBF in Malaysia steadily increased from 61.5% in 2017 to 71.8% in 2021 ( 10 ), thus achieving the 70% exclusive breastfeeding target set by WHO. Efforts to increase EBF practices in Malaysia encompass a range of breastfeeding-related programmes available in public and private antenatal and postnatal care. Among these initiatives are 14-week maternity leave, tax exemptions on breastfeeding-related purchases, breastfeeding classes, professional and peer support groups. However, despite receiving the same breastfeeding programme as other Malaysian states, Malacca has seen a decline in EBF prevalence. It fell from 52.4% in 2017 to 40.0% in 2021 and dropped further to 37% in 2023 ( 11 , 12 ). Maternal employment is frequently cited as a barrier to breastfeeding. A meta-analysis study showed that working mothers were 57% less likely to practise EBF in comparison to non-working mothers ( 13 ). Working mothers often struggle to balance breastfeeding with their paid employment, thereby increasing the risk of early cessation of breastfeeding in general and exclusive breastfeeding in particular ( 14 , 15 ). A strong intention to exclusively breastfeed significantly increases the likelihood of actual EBF practice. Many authors highlight prenatal intention as one of the strongest predictors of breastfeeding intensity and duration ( 16 – 18 ). A cohort study showed that prenatal intention to breastfeed was 27.5 times more likely to result in continued breastfeeding for six months (95% CI: 24.8, 30.5) ( 18 ). Breastfeeding knowledge, attitude, subjective norm, and perceived control were identified as predictive factors for EBF intention ( 7 , 16 , 19 – 21 ). Due to limited intervention research on EBF intention among working mothers ( 22 , 23 ), a study addressing this research gap in Malaysia is crucial to improve EBF practices by targeting these predictive factors. Moreover, the Theory of Planned Behaviour (TPB)-based health education is an important tool to enhance knowledge, improve attitude and norms, and empower working mothers in strengthening their EBF intention. This hopefully will increase the breastfeeding practices and reduce infant mortality and morbidity in Malaysia. The intervention module developed from this study may be adopted and consolidated into routine health education delivered to working mothers during their antenatal and postnatal care visits. Hypothesis A health education intervention module based on TPB will produce changes in knowledge, attitude, subjective norm, and perceived behavioural control regarding breastfeeding, which, in turn, will improve working mothers’ intention to exclusively breastfeed. Objectives The main objective of this study is to determine the effect of a theory-based health education intervention on improving EBF intention among working mothers. Specific objectives of this study include: 1. To describe and compare sociodemographic characteristics, attitude, subjective norm, perceived behavioural control, knowledge and exclusive breastfeeding intention at baseline between the intervention and control groups. 2. To determine and compare the attitude, subjective norm, perceived behavioural control, knowledge, and exclusive breastfeeding intention at baseline, 1 month and 4 months postnatal, both within and between the intervention and control groups. 3. To evaluate the effect of the theory-based health education intervention on attitude, subjective norm, perceived behavioural control, knowledge, and exclusive breastfeeding intention, whist controlling for covariates. Methods Study design This study is a two-armed, single-blinded, parallel, cluster randomised controlled trial. One cluster is defined as a comparable government health clinic within the jurisdiction of the Central Malacca Health District Office. The government health clinics will be randomised into intervention and control groups with a 1:1 allocation to prevent contamination. All pregnant women who satisfy the inclusion and exclusion criteria of the selected clusters will be invited to participate in the study during the recruitment period to enhance the generalisability and representativeness of the study population. Participants will not be aware of their group assignment (single-blinded). The health education material will be provided to the intervention group after baseline data collection, while the control group will receive routine antenatal education based on the Ministry of Health Malaysia’s guidelines. Upon completion of data collection, the control group will also receive the same health education material. Data collection for the assessment of both groups will be carried out prospectively at baseline, 1 month, and 4 months postnatal. Study duration This study will be conducted over a period of 30-month period, from 1st October 2023 until 30th March 2026, with data collection beginning on 1st June 2025. The study’s duration encompasses research planning, development of the theory-based intervention module, implementation, and evaluation of the intervention’s effectiveness. Study setting and sampling population This research will be conducted within government health clinics located in the Central Malacca District, Malacca, Malaysia. It is imperative to note that all health clinics in Malaysia fall under the jurisdiction of the Ministry of Health Malaysia. This district has a total of 14 government health clinics; however, one of these do not provide maternal and children health (MCH) services. Eight clinics will be chosen using a simple online randomisation method; subsequently, four health clinics will be randomised into the intervention group and the remaining four into the control group. The targeted population for sampling comprises pregnant mothers utilising routine antenatal care at these health clinics during the stipulated recruitment period. The selection of study participants will adhere strictly to the predetermined inclusion and exclusion criteria as outlined in this protocol. Recruitment Recruitment of the study participants will be based on health clinic criteria and participant criteria. The inclusion criteria for the health clinic selection in this study are: they must be government health clinics, they must provide MCH services, and they must have obtained consent from the District Health Officer of Central Malacca District. The inclusion criteria for the participants selection in this study are: they must be Malaysian citizens, they must be antenatal mothers of age 18 years and above, who are in their third trimester and plan to return to work after completing their maternity leave. The exclusion criteria are: inability to read or understand Malay or English, mentally impaired individuals who are disability card holders, mothers with underlying illnesses that contraindicate breastfeeding, as identified through reviewing their antenatal health record book, and mothers of infants with conditions that prevent the ingestion of breastmilk, such as cleft palate or classic galactosemia, as identified through reviewing their postnatal discharge note. Participants meeting the inclusion criteria will be selected via convenience sampling and approached to have the study objectives, risks, and benefits explained in a simply and clearly. If they agree to participate, they will provide written informed consent and complete a questionnaire for baseline assessment. Figure 1 illustrates the procedure involved in the randomisation and recruitment of participants in the study, adhering to the CONSORT guideline model. Sample size estimation To achieve 80% power with a 95% confidence interval for this study, a sample size of 92 participants per arm was determined using the following formula ( 24 ). This formula incorporated means of 90.34 and 84.22 derived from a similar intervention evaluation study on attitude towards breastfeeding ( 25 ). Accounting for a 20% attrition rate and a design effect of 1.95 to address clustering effects ( 26 ), the anticipated total sample size required is 108 participants for each arm. Consequently, the overall sample size needed for this study is 216, representing the calculated sample size required to test the hypothesis. Based on this calculated sample size, participants will be recruited from each cluster using proportion-to-size sampling during the recruitment period. Development of the intervention module This study's health education intervention module was developed by adapting the Three Phases of Intervention Module Development (3P-IMD) framework ( 26 ). This framework comprises three phases: Phase I (need assessment), Phase II (intervention module development), and Phase III (implementation and effectiveness assessment). In Phase I, the needs assessment of the intervention was designed through a comprehensive review of existing literature, a modification from the original 3P-IMD. The insights gathered from this review were then used for the subsequent phase (Phase II). This included the design of the methodology and media for delivery, content formulation, and establishment of the assessment framework. In Phase II, the TPB was used as the basis of development as it offers a strong construct on attitude, subjective norm, and perceived behavioural control regarding exclusive breastfeeding intention among working mothers. Existing literature, including guidelines and statements, on the benefits of exclusive breastfeeding, breastfeeding among working mothers, and expressed breast milk and storage from the World Health Organization (WHO), United Nations Children’s Fund (UNICEF), International Labour Organization (ILO), Centers for Disease Control and Prevention (CDC), Academy of Breastfeeding Medicine (ABM) Protocol, various breastfeeding journals and protocols ( 5 , 9 , 27 – 35 ) was reviewed and adapted. Local guidelines covering various aspects, such as employment and breastfeeding policy ( 36 – 38 ), were also reviewed and adapted for the intervention module. Discussions with experts, including public health physicians and lactation nurses, were also conducted to develop the module draft. The module draft was then assessed and validated by a multi-disciplinary panel, including nutritionists, health education officers, and family medicine specialists, using the Content Validity Achievement assessment ( 39 ). All panels were well informed and familiar with breastfeeding education. For the face validity of the intervention module, five working mothers were asked to provide feedback based on the Malaysian version of the Patient Education Materials Assessment Tool ( 40 ). Based on these assessments and feedback, some clarifications and adjustments were made. In Phase III, the final module will be implemented at selected health clinics within the intervention group. To ensure intervention standardisation, the intervention will be given by the principal investigator. Pre- and post-intervention questionnaires will be collected using validated, self-administered questionnaires at three time points (T 0 = baseline, T 1 = 1 month postnatal, and T 2 = 4 months postnatal) to measure the intervention module’s effectiveness. Intervention design Following baseline data collection, the intervention group will receive a 120-minute face-to-face health education session during their antenatal period. This will be complemented by a 60-minute weekly educational intervention delivered via a mobile application (WhatsApp) for two weeks postnatally. Lectures, discussions and brainstorming, audiovisual aids, PowerPoint presentations, dissemination of educational materials, peer sharing, guided practice, and observational learning will be the educational methods and materials in delivering the intervention module. The face-to-face session will be conducted in health clinics for the intervention group during participants’ antenatal visits while the control group will receive routine antenatal education. Data Collection Data will be collected in person during clinic visits. All primary and secondary outcomes will be assessed prospectively using a standardised and validated questionnaire. This questionnaire will be administered to the study participants across three time points; for baseline (T 0 ) antenatally during the third trimester, T 1 at 1 month postnatal, and T 2 at 4 months postnatal (Table 1 ). The data collection tools, listed below, are adapted from validated scales from previous studies, that have been used with vulnerable populations. a. Sociodemographic Characteristics Questionnaire – to assess maternal age, educational attainment, number of living children, occupation, and previous breastfeeding experiences. b. Exclusive Breastfeeding Intention Scale – a 5-item scale that assesses pregnant mothers’ intention to exclusively breastfeed their infant for six months prenatally and postnatally, adapted from validated Infant Feeding Intention Scale ( 41 ) which has been translated into the Malay Language and validated ( 42 ). Higher scores reflect higher intention to practice exclusive breastfeeding. c. Exclusive Breastfeeding Practice Checklist – an adapted checklist ( 43 ) to assess participants’ self-reported feeding practice postnatally at T1 and T2 time points. d. Breastfeeding Knowledge Questionnaire – a 42-item true/false questionnaire adapted from the Breastfeeding Knowledge Questionnaire ( 44 ) which covers the domains of knowledge on breastfeeding including breastfeeding advantage to mothers and babies, expressed breast milk, breastfeeding problems and practical aspects of breastfeeding. Higher scores reflect higher breastfeeding knowledge. e. Attitude Towards Breastfeeding Scale – this refers to pregnant mother’s beliefs, feelings, values, and dispositions toward breastfeeding and will be measured using a 17-item modified version of the Iowa Infant Feeding Attitude Scale ( 45 ). For this instrument, higher score reflects a better attitude toward breastfeeding. f. Subjective Norm Scale – a 7-item scale adapted and modified from the validated perceived norm component of the Exclusive Breastfeeding Theory of Planned Behaviour Questionnaire ( 46 ) and the workplace breastfeeding support questionnaire ( 47 ). A 7-point Likert scale will be used for measurement, with higher scores reflecting higher subjective norm. g. Perceived Behavioural Control Scale – a 14-item scale adapted from the validated Breastfeeding Self-Efficacy Scale-short form ( 48 ). Higher scores indicate higher perceived control. Table 1 Overview of the study schedule of assessments Study instrument Prenatal (T 0 ) Postnatal Data Collection 1 month (T 1 ) 4 months (T 2 ) Sociodemographic characteristics √ Exclusive breastfeeding intention √ √ √ Exclusive breastfeeding practice √ √ Knowledge on breastfeeding √ √ √ Attitude toward breastfeeding √ √ √ Subjective norm √ √ √ Perceived behaviour control √ √ √ Table 1 shows the timing of data collection for each study instrument. Prenatal, or baseline, data will be collected during enrolment in the third trimester, once participants have agreed to participate in the study. The 1-month and 4-month postnatal data will be collected within 14 days before or after the exact time point, specifically during clinic visits for their infant’s vaccination schedule. Any participants who miss their clinic visits will receive a Google Form link to complete the assessment via WhatsApp mobile application. If no response is received through the Google Form, participants will be contacted by phone calls to complete the assessment. The questionnaire was initially prepared in English, then translated and back-translated into Malay, guided by the WHODAS 2.0 Translation Package (49). Data monitoring and management As data will be collected face-to-face during clinic visits, any incompleteness will be addressed immediately with the study participant. All remotely administered assessments will be reviewed by the principal investigator for responses and completeness. In the event of any inconsistencies, attempts will be made to contact the participant for clarification. Participants’ names will be kept on a password-protected database and will be linked only with a study identification number for this research. The identification number, instead of patient identifiers, will be used on subject data sheets. All data will be entered into a password-protected computer. Upon study completion, data on the computer will be copied to CDs, and the data in the computer will be erased. CDs and any hard copy data will be stored in a locked office belonging to the investigators and maintained for a minimum of three years after the study’s completion. The CDs and data will be destroyed after this storage period. Participants will not be permitted to view their personal information and study data, as the data will be consolidated into a database. Data analysis The collected data will be analysed using the IBM Statistical Package for Social Science (SPSS) version 27.0, involving descriptive and inferential statistics. Data exploration will be performed to check for any errors in data entry, missing data, and the presence of outliers. Descriptive analysis will be performed for all variables. The Kolmogorov-Smirnov test and histograms will be used to determine the normality of the variable data. Variables will be measured and compared between groups using independent t-tests for continuous variables and chi-square tests for categorical variables. Generalised Estimating Equation analysis will be employed to test the main effect and interaction between and within the intervention and control groups over time (baseline, 1 month, and 4 months postnatal). Differences between and within groups will be considered statistically significant at the 0.05 level of significance. The primary analysis will be performed using an intention-to-treat analysis based on which treatment group the participants were randomised to. Secondary analysis, using per-protocol analysis, will also be performed for each of the primary and secondary outcomes. Discussion To our knowledge, this will be the first exclusive breastfeeding intention intervention to be conducted with the application of health behaviour theory targeting pregnant mothers. It is hypothesised that there will be a significant improvement in exclusive breastfeeding intention among the intervention group as compared to the control group. Strengths and Limitations of this study This study will employ a systematic, step-by-step intervention module development process incorporating, literature review and needs assessment derived from the relevant target population and various subject matter experts. This approach aims to ensure the resulting intervention is effective and impactful in achieving the intended outcome. Risk of contamination is minimised as cluster randomisation will be used in this study. Thus, the effect of the intervention module on the intended outcome can be measured confidently. Several challenges are anticipated during the study period. Should enrolment fall short of expectations, initiatives such as adjusting recruitment methods, extending enrolment periods, and fostering cooperation with other research institutions can be implemented. Education, regular contact, reminders, support services, and incentives can all help to increase patient adherence. Furthermore, predefined protocols for assessment, reporting, and interventions will be devised for concurrent events, and such events will be monitored, documented, and appraised for their impact on the study. Abbreviations EBF Exclusive breastfeeding TPB Theory of planned behaviour MCH Mother and children health Declarations Ethical approval and consent to participate The study protocol was approved by Ministry of Health Malaysia Medical Research and Ethics Committee (NMRR ID-24-02852-NQU (IIR) and the trial has been registered under the Thai Clinical Trial Registry (TCTR20250116001), dated 16 th January 2025. Participants are required to provide signed consent to participate in this study at time of recruitment. Respondents are allowed to withdraw at any point during the study. Consent for publication Not applicable. Available data and materials Not applicable. Competing interests The authors declare that they have no competing interests. Funding This study is supported by the Community Health Department of Universiti Putra Malaysia. Author Contributions Conceptualisation: KQAH, NAMZ, and NA. Methodology: KQAH, NAMZ, NA and AZFA. Drafted the manuscript: KQAH. Revised and editing the manuscript: KQAH and NAMZ. All authors read and approved the final manuscript. Acknowledgments Not applicable. References World Health Organization (WHO). Fact sheets. 2021 [cited 2023 Nov 10]. Infant and young child feeding. Available from: https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding Louis-Jacques AF, Stuebe AM. Enabling Breastfeeding to Support Lifelong Health for Mother and Child. Obstet Gynecol Clin North Am [Internet]. 2020;47(3):363–81. Available from: https://doi.org/10.1016/j.ogc.2020.04.001 Pérez-Escamilla R, Tomori C, Hernández-Cordero S, Baker P, Barros AJD, Bégin F, et al. 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Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 17 Sep, 2025 Reviews received at journal 17 Sep, 2025 Reviewers agreed at journal 17 Sep, 2025 Reviews received at journal 17 Aug, 2025 Reviewers agreed at journal 16 Aug, 2025 Reviewers invited by journal 14 Aug, 2025 Editor assigned by journal 23 Jul, 2025 Submission checks completed at journal 23 Jul, 2025 First submitted to journal 17 Jul, 2025 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. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7153570","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":501635031,"identity":"7bd76603-449e-4161-88fd-74803b63ac5d","order_by":0,"name":"Khadijahtul Qubra Amizah Hamzah","email":"","orcid":"","institution":"Universiti Putra Malaysia","correspondingAuthor":false,"prefix":"","firstName":"Khadijahtul","middleName":"Qubra Amizah","lastName":"Hamzah","suffix":""},{"id":501635032,"identity":"d0da05cd-4407-4518-8bba-cc557c2accf4","order_by":1,"name":"Nor Afiah Mohd Zulkefli","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA1UlEQVRIiWNgGAWjYLCCCgOGBH4Ik5lILWeAWiQbSNPCwJBgcIBYLebsvQ8/HCiwyzO+kXt0A0OFdWKDGNBSfMCy57ixxAGD5GKzG3lpNxjOpCc2SOfg12JwI41B+oMBc+K2GzlmNxjbDhOlhfnHAYP6xM0zQFr+EaeFDeiww4kbJEBaGojRcuYYm8UBg+OJM868S7uRcCzduE06rQC/luNtzDcO/KlO7G/PPXbjQ421bL908ga8WpAADzB2gBQbAwd+h6FqgQD2B8RqGQWjYBSMgpEBALlQTHpymANUAAAAAElFTkSuQmCC","orcid":"","institution":"Universiti Putra Malaysia","correspondingAuthor":true,"prefix":"","firstName":"Nor","middleName":"Afiah Mohd","lastName":"Zulkefli","suffix":""},{"id":501635033,"identity":"cb98db14-064b-4bae-bb8d-f24d7b467eac","order_by":2,"name":"Norliza Ahmad","email":"","orcid":"","institution":"Universiti Putra Malaysia","correspondingAuthor":false,"prefix":"","firstName":"Norliza","middleName":"","lastName":"Ahmad","suffix":""},{"id":501635034,"identity":"d3b64bc9-462c-4da7-b06a-519031d13f46","order_by":3,"name":"Ahmad Zaid Fattah Azman","email":"","orcid":"","institution":"Universiti Putra Malaysia","correspondingAuthor":false,"prefix":"","firstName":"Ahmad","middleName":"Zaid Fattah","lastName":"Azman","suffix":""}],"badges":[],"createdAt":"2025-07-18 03:53:18","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7153570/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7153570/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":89971136,"identity":"d33a1520-e3a8-407a-a1fa-16a034b83b1f","added_by":"auto","created_at":"2025-08-27 05:36:00","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":135071,"visible":true,"origin":"","legend":"\u003cp\u003eCONSORT extension for Cluster Trials\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7153570/v1/76c1f4d8b9c5c20b3aeffa3d.png"},{"id":89973758,"identity":"12f20484-ec83-41d0-ac97-298456cd2f97","added_by":"auto","created_at":"2025-08-27 05:52:00","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":775670,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7153570/v1/c546a962-414e-4cb6-aa03-41d620ce9e01.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effect Of Theory-Based Health Education Intervention In Improving Exclusive Breastfeeding Intention Among Working Mothers: A Study Protocol For A Cluster Randomised Controlled Trial","fulltext":[{"header":"Background","content":"\u003cp\u003eBreastfeeding is vital for a child\u0026rsquo;s survival and health. Breast milk is a safe, natural, and sustainable food, considered the most complete nutritional source for infants (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e). It contains immunological factors necessary for infants to thrive and resist many common childhood infections and severe diseases such as diarrhoea and respiratory illnesses. Furthermore, it possesses the highest life-saving potential, preventing half a million infant deaths and 13% of child deaths globally (\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e). Breastfed children tend to perform better on intelligence tests and are less likely to be overweight or obese later in life (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e). Women who breastfeed also benefit personally from the practice, as it can reduce their risk of certain cancers and Type II diabetes (\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eBoth the United Nations Children\u0026rsquo;s Fund (UNICEF) and WHO recommend that infants begin breastfeeding within the first hour of life, are exclusively breastfed for the first six months, and continue breastfeeding until at least two years of age (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e). Exclusive breastfeeding (EBF) is defined as \u0026ldquo;when an infant receives only breast milk and no other liquids or solids, including water, with the exception of prescribed vitamins, minerals or medicines\u0026rdquo; (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e). This breastfeeding practice is the most effective global public health intervention in ensuring optimal health and development in infants (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eDespite awareness efforts by various governments and non-governmental organisations on the benefits of EBF, the prevalence of adequate breastfeeding practice remains a global concern (\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e). Globally, only 43.5% of infants were exclusively breastfed in 2019, a mere ten-percentage-point increment from the 34.0% reported in 1990 (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e). EBF was highest in Latin America (59.7%), followed by Oceania (56.8%), and South Asia (53.9%) (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e). However, many countries are not on track to meet the WHO Global Nutrition Target of at least 50% EBF infants under six months by 2025 and 70% by 2030 (\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eThe prevalence of EBF in Malaysia steadily increased from 61.5% in 2017 to 71.8% in 2021 (\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e), thus achieving the 70% exclusive breastfeeding target set by WHO. Efforts to increase EBF practices in Malaysia encompass a range of breastfeeding-related programmes available in public and private antenatal and postnatal care. Among these initiatives are 14-week maternity leave, tax exemptions on breastfeeding-related purchases, breastfeeding classes, professional and peer support groups. However, despite receiving the same breastfeeding programme as other Malaysian states, Malacca has seen a decline in EBF prevalence. It fell from 52.4% in 2017 to 40.0% in 2021 and dropped further to 37% in 2023 (\u003cspan class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eMaternal employment is frequently cited as a barrier to breastfeeding. A meta-analysis study showed that working mothers were 57% less likely to practise EBF in comparison to non-working mothers (\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e). Working mothers often struggle to balance breastfeeding with their paid employment, thereby increasing the risk of early cessation of breastfeeding in general and exclusive breastfeeding in particular (\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eA strong intention to exclusively breastfeed significantly increases the likelihood of actual EBF practice. Many authors highlight prenatal intention as one of the strongest predictors of breastfeeding intensity and duration (\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e). A cohort study showed that prenatal intention to breastfeed was 27.5 times more likely to result in continued breastfeeding for six months (95% CI: 24.8, 30.5) (\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e). Breastfeeding knowledge, attitude, subjective norm, and perceived control were identified as predictive factors for EBF intention (\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eDue to limited intervention research on EBF intention among working mothers (\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e), a study addressing this research gap in Malaysia is crucial to improve EBF practices by targeting these predictive factors. Moreover, the Theory of Planned Behaviour (TPB)-based health education is an important tool to enhance knowledge, improve attitude and norms, and empower working mothers in strengthening their EBF intention. This hopefully will increase the breastfeeding practices and reduce infant mortality and morbidity in Malaysia. The intervention module developed from this study may be adopted and consolidated into routine health education delivered to working mothers during their antenatal and postnatal care visits.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypothesis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA health education intervention module based on TPB will produce changes in knowledge, attitude, subjective norm, and perceived behavioural control regarding breastfeeding, which, in turn, will improve working mothers\u0026rsquo; intention to exclusively breastfeed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjectives\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe main objective of this study is to determine the effect of a theory-based health education intervention on improving EBF intention among working mothers. Specific objectives of this study include:\u003c/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e1. To describe and compare sociodemographic characteristics, attitude, subjective norm, perceived behavioural control, knowledge and exclusive breastfeeding intention at baseline between the intervention and control groups.\u003c/p\u003e\u003cspan\u003e\n \u003cp\u003e2. To determine and compare the attitude, subjective norm, perceived behavioural control, knowledge, and exclusive breastfeeding intention at baseline, 1 month and 4 months postnatal, both within and between the intervention and control groups.\u003c/p\u003e\n\u003c/span\u003e\u003cspan\u003e\n \u003cp\u003e3. To evaluate the effect of the theory-based health education intervention on attitude, subjective norm, perceived behavioural control, knowledge, and exclusive breastfeeding intention, whist controlling for covariates.\u003c/p\u003e\n\u003c/span\u003e\n\u003cp\u003e\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study is a two-armed, single-blinded, parallel, cluster randomised controlled trial. One cluster is defined as a comparable government health clinic within the jurisdiction of the Central Malacca Health District Office. The government health clinics will be randomised into intervention and control groups with a 1:1 allocation to prevent contamination. All pregnant women who satisfy the inclusion and exclusion criteria of the selected clusters will be invited to participate in the study during the recruitment period to enhance the generalisability and representativeness of the study population.\u003c/p\u003e\n\u003cp\u003eParticipants will not be aware of their group assignment (single-blinded). The health education material will be provided to the intervention group after baseline data collection, while the control group will receive routine antenatal education based on the Ministry of Health Malaysia\u0026rsquo;s guidelines. Upon completion of data collection, the control group will also receive the same health education material. Data collection for the assessment of both groups will be carried out prospectively at baseline, 1 month, and 4 months postnatal.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy duration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study will be conducted over a period of 30-month period, from 1st October 2023 until 30th March 2026, with data collection beginning on 1st June 2025. The study\u0026rsquo;s duration encompasses research planning, development of the theory-based intervention module, implementation, and evaluation of the intervention\u0026rsquo;s effectiveness.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy setting and sampling population\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research will be conducted within government health clinics located in the Central Malacca District, Malacca, Malaysia. It is imperative to note that all health clinics in Malaysia fall under the jurisdiction of the Ministry of Health Malaysia. This district has a total of 14 government health clinics; however, one of these do not provide maternal and children health (MCH) services. Eight clinics will be chosen using a simple online randomisation method; subsequently, four health clinics will be randomised into the intervention group and the remaining four into the control group. The targeted population for sampling comprises pregnant mothers utilising routine antenatal care at these health clinics during the stipulated recruitment period. The selection of study participants will adhere strictly to the predetermined inclusion and exclusion criteria as outlined in this protocol.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRecruitment of the study participants will be based on health clinic criteria and participant criteria. The inclusion criteria for the health clinic selection in this study are: they must be government health clinics, they must provide MCH services, and they must have obtained consent from the District Health Officer of Central Malacca District. The inclusion criteria for the participants selection in this study are: they must be Malaysian citizens, they must be antenatal mothers of age 18 years and above, who are in their third trimester and plan to return to work after completing their maternity leave. The exclusion criteria are: inability to read or understand Malay or English, mentally impaired individuals who are disability card holders, mothers with underlying illnesses that contraindicate breastfeeding, as identified through reviewing their antenatal health record book, and mothers of infants with conditions that prevent the ingestion of breastmilk, such as cleft palate or classic galactosemia, as identified through reviewing their postnatal discharge note.\u003c/p\u003e\n\u003cp\u003eParticipants meeting the inclusion criteria will be selected via convenience sampling and approached to have the study objectives, risks, and benefits explained in a simply and clearly. If they agree to participate, they will provide written informed consent and complete a questionnaire for baseline assessment. Figure \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e illustrates the procedure involved in the randomisation and recruitment of participants in the study, adhering to the CONSORT guideline model.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size estimation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo achieve 80% power with a 95% confidence interval for this study, a sample size of 92 participants per arm was determined using the following formula (\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e). This formula incorporated means of 90.34 and 84.22 derived from a similar intervention evaluation study on attitude towards breastfeeding (\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003e\u003cimg src=\"data:image/png;base64,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\"\u003e\u003c/p\u003e\n\u003cp\u003eAccounting for a 20% attrition rate and a design effect of 1.95 to address clustering effects (\u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e), the anticipated total sample size required is 108 participants for each arm. Consequently, the overall sample size needed for this study is 216, representing the calculated sample size required to test the hypothesis. Based on this calculated sample size, participants will be recruited from each cluster using proportion-to-size sampling during the recruitment period.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDevelopment of the intervention module\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study\u0026apos;s health education intervention module was developed by adapting the Three Phases of Intervention Module Development (3P-IMD) framework (\u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e). This framework comprises three phases: Phase I (need assessment), Phase II (intervention module development), and Phase III (implementation and effectiveness assessment).\u003c/p\u003e\n\u003cp\u003eIn Phase I, the needs assessment of the intervention was designed through a comprehensive review of existing literature, a modification from the original 3P-IMD. The insights gathered from this review were then used for the subsequent phase (Phase II). This included the design of the methodology and media for delivery, content formulation, and establishment of the assessment framework.\u003c/p\u003e\n\u003cp\u003eIn Phase II, the TPB was used as the basis of development as it offers a strong construct on attitude, subjective norm, and perceived behavioural control regarding exclusive breastfeeding intention among working mothers. Existing literature, including guidelines and statements, on the benefits of exclusive breastfeeding, breastfeeding among working mothers, and expressed breast milk and storage from the World Health Organization (WHO), United Nations Children\u0026rsquo;s Fund (UNICEF), International Labour Organization (ILO), Centers for Disease Control and Prevention (CDC), Academy of Breastfeeding Medicine (ABM) Protocol, various breastfeeding journals and protocols (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e) was reviewed and adapted. Local guidelines covering various aspects, such as employment and breastfeeding policy (\u003cspan class=\"CitationRef\"\u003e36\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e38\u003c/span\u003e), were also reviewed and adapted for the intervention module. Discussions with experts, including public health physicians and lactation nurses, were also conducted to develop the module draft.\u003c/p\u003e\n\u003cp\u003eThe module draft was then assessed and validated by a multi-disciplinary panel, including nutritionists, health education officers, and family medicine specialists, using the Content Validity Achievement assessment (\u003cspan class=\"CitationRef\"\u003e39\u003c/span\u003e). All panels were well informed and familiar with breastfeeding education. For the face validity of the intervention module, five working mothers were asked to provide feedback based on the Malaysian version of the Patient Education Materials Assessment Tool (\u003cspan class=\"CitationRef\"\u003e40\u003c/span\u003e). Based on these assessments and feedback, some clarifications and adjustments were made.\u003c/p\u003e\n\u003cp\u003eIn Phase III, the final module will be implemented at selected health clinics within the intervention group. To ensure intervention standardisation, the intervention will be given by the principal investigator. Pre- and post-intervention questionnaires will be collected using validated, self-administered questionnaires at three time points (T\u003csub\u003e0\u003c/sub\u003e\u0026thinsp;=\u0026thinsp;baseline, T\u003csub\u003e1\u003c/sub\u003e\u0026thinsp;=\u0026thinsp;1 month postnatal, and T\u003csub\u003e2\u003c/sub\u003e\u0026thinsp;=\u0026thinsp;4 months postnatal) to measure the intervention module\u0026rsquo;s effectiveness.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFollowing baseline data collection, the intervention group will receive a 120-minute face-to-face health education session during their antenatal period. This will be complemented by a 60-minute weekly educational intervention delivered via a mobile application (WhatsApp) for two weeks postnatally. Lectures, discussions and brainstorming, audiovisual aids, PowerPoint presentations, dissemination of educational materials, peer sharing, guided practice, and observational learning will be the educational methods and materials in delivering the intervention module. The face-to-face session will be conducted in health clinics for the intervention group during participants\u0026rsquo; antenatal visits while the control group will receive routine antenatal education.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Collection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData will be collected in person during clinic visits. All primary and secondary outcomes will be assessed prospectively using a standardised and validated questionnaire. This questionnaire will be administered to the study participants across three time points; for baseline (T\u003csub\u003e0\u003c/sub\u003e) antenatally during the third trimester, T\u003csub\u003e1\u003c/sub\u003e at 1 month postnatal, and T\u003csub\u003e2\u003c/sub\u003e at 4 months postnatal (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). The data collection tools, listed below, are adapted from validated scales from previous studies, that have been used with vulnerable populations.\u003c/p\u003e\n\u003cp\u003e\u003c/p\u003e\n\u003cp\u003ea. Sociodemographic Characteristics Questionnaire \u0026ndash; to assess maternal age, educational attainment, number of living children, occupation, and previous breastfeeding experiences.\u003c/p\u003e\u003cspan\u003e\n \u003cp\u003eb. Exclusive Breastfeeding Intention Scale \u0026ndash; a 5-item scale that assesses pregnant mothers\u0026rsquo; intention to exclusively breastfeed their infant for six months prenatally and postnatally, adapted from validated Infant Feeding Intention Scale (\u003cspan class=\"CitationRef\"\u003e41\u003c/span\u003e) which has been translated into the Malay Language and validated (\u003cspan class=\"CitationRef\"\u003e42\u003c/span\u003e). Higher scores reflect higher intention to practice exclusive breastfeeding.\u003c/p\u003e\n\u003c/span\u003e\u003cspan\u003e\n \u003cp\u003ec. Exclusive Breastfeeding Practice Checklist \u0026ndash; an adapted checklist (\u003cspan class=\"CitationRef\"\u003e43\u003c/span\u003e) to assess participants\u0026rsquo; self-reported feeding practice postnatally at T1 and T2 time points.\u003c/p\u003e\n\u003c/span\u003e\u003cspan\u003e\n \u003cp\u003ed. Breastfeeding Knowledge Questionnaire \u0026ndash; a 42-item true/false questionnaire adapted from the Breastfeeding Knowledge Questionnaire (\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e) which covers the domains of knowledge on breastfeeding including breastfeeding advantage to mothers and babies, expressed breast milk, breastfeeding problems and practical aspects of breastfeeding. Higher scores reflect higher breastfeeding knowledge.\u003c/p\u003e\n\u003c/span\u003e\u003cspan\u003e\n \u003cp\u003ee. Attitude Towards Breastfeeding Scale \u0026ndash; this refers to pregnant mother\u0026rsquo;s beliefs, feelings, values, and dispositions toward breastfeeding and will be measured using a 17-item modified version of the Iowa Infant Feeding Attitude Scale (\u003cspan class=\"CitationRef\"\u003e45\u003c/span\u003e). For this instrument, higher score reflects a better attitude toward breastfeeding.\u003c/p\u003e\n\u003c/span\u003e\u003cspan\u003e\n \u003cp\u003ef. Subjective Norm Scale \u0026ndash; a 7-item scale adapted and modified from the validated perceived norm component of the Exclusive Breastfeeding Theory of Planned Behaviour Questionnaire (\u003cspan class=\"CitationRef\"\u003e46\u003c/span\u003e) and the workplace breastfeeding support questionnaire (\u003cspan class=\"CitationRef\"\u003e47\u003c/span\u003e). A 7-point Likert scale will be used for measurement, with higher scores reflecting higher subjective norm.\u003c/p\u003e\n\u003c/span\u003e\u003cspan\u003e\n \u003cp\u003eg. Perceived Behavioural Control Scale \u0026ndash; a 14-item scale adapted from the validated Breastfeeding Self-Efficacy Scale-short form (\u003cspan class=\"CitationRef\"\u003e48\u003c/span\u003e). Higher scores indicate higher perceived control.\u003c/p\u003e\n\u003c/span\u003e\n\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eOverview of the study schedule of assessments\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eStudy instrument\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003ePrenatal (T\u003csub\u003e0\u003c/sub\u003e)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003ePostnatal Data Collection\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e1 month (T\u003csub\u003e1\u003c/sub\u003e)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e4 months (T\u003csub\u003e2\u003c/sub\u003e)\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSociodemographic characteristics\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eExclusive breastfeeding intention\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eExclusive breastfeeding practice\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eKnowledge on breastfeeding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAttitude toward breastfeeding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSubjective norm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePerceived behaviour control\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e shows the timing of data collection for each study instrument. Prenatal, or baseline, data will be collected during enrolment in the third trimester, once participants have agreed to participate in the study. The 1-month and 4-month postnatal data will be collected within 14 days before or after the exact time point, specifically during clinic visits for their infant\u0026rsquo;s vaccination schedule. Any participants who miss their clinic visits will receive a Google Form link to complete the assessment via WhatsApp mobile application. If no response is received through the Google Form, participants will be contacted by phone calls to complete the assessment. The questionnaire was initially prepared in English, then translated and back-translated into Malay, guided by the WHODAS 2.0 Translation Package (49).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData monitoring and management\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAs data will be collected face-to-face during clinic visits, any incompleteness will be addressed immediately with the study participant. All remotely administered assessments will be reviewed by the principal investigator for responses and completeness. In the event of any inconsistencies, attempts will be made to contact the participant for clarification.\u003c/p\u003e\n\u003cp\u003eParticipants\u0026rsquo; names will be kept on a password-protected database and will be linked only with a study identification number for this research. The identification number, instead of patient identifiers, will be used on subject data sheets. All data will be entered into a password-protected computer. Upon study completion, data on the computer will be copied to CDs, and the data in the computer will be erased. CDs and any hard copy data will be stored in a locked office belonging to the investigators and maintained for a minimum of three years after the study\u0026rsquo;s completion. The CDs and data will be destroyed after this storage period. Participants will not be permitted to view their personal information and study data, as the data will be consolidated into a database.\u003c/p\u003e\n\u003ch2\u003eData analysis\u003c/h2\u003e\n\u003cp\u003eThe collected data will be analysed using the IBM Statistical Package for Social Science (SPSS) version 27.0, involving descriptive and inferential statistics. Data exploration will be performed to check for any errors in data entry, missing data, and the presence of outliers. Descriptive analysis will be performed for all variables. The Kolmogorov-Smirnov test and histograms will be used to determine the normality of the variable data. Variables will be measured and compared between groups using independent t-tests for continuous variables and chi-square tests for categorical variables. Generalised Estimating Equation analysis will be employed to test the main effect and interaction between and within the intervention and control groups over time (baseline, 1 month, and 4 months postnatal). Differences between and within groups will be considered statistically significant at the 0.05 level of significance.\u003c/p\u003e\n\u003cp\u003eThe primary analysis will be performed using an intention-to-treat analysis based on which treatment group the participants were randomised to. Secondary analysis, using per-protocol analysis, will also be performed for each of the primary and secondary outcomes.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eTo our knowledge, this will be the first exclusive breastfeeding intention intervention to be conducted with the application of health behaviour theory targeting pregnant mothers. It is hypothesised that there will be a significant improvement in exclusive breastfeeding intention among the intervention group as compared to the control group.\u003c/p\u003e\u003cp\u003e\u003cb\u003eStrengths and Limitations of this study\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis study will employ a systematic, step-by-step intervention module development process incorporating, literature review and needs assessment derived from the relevant target population and various subject matter experts. This approach aims to ensure the resulting intervention is effective and impactful in achieving the intended outcome. Risk of contamination is minimised as cluster randomisation will be used in this study. Thus, the effect of the intervention module on the intended outcome can be measured confidently.\u003c/p\u003e\u003cp\u003eSeveral challenges are anticipated during the study period. Should enrolment fall short of expectations, initiatives such as adjusting recruitment methods, extending enrolment periods, and fostering cooperation with other research institutions can be implemented. Education, regular contact, reminders, support services, and incentives can all help to increase patient adherence. Furthermore, predefined protocols for assessment, reporting, and interventions will be devised for concurrent events, and such events will be monitored, documented, and appraised for their impact on the study.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eEBF\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eExclusive breastfeeding\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eTPB\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eTheory of planned behaviour\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eMCH\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eMother and children health\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003ch2\u003eEthical approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eThe study protocol was approved by Ministry of Health Malaysia Medical Research and Ethics Committee\u0026nbsp;(NMRR ID-24-02852-NQU (IIR) and the trial has been registered under the Thai Clinical Trial Registry (TCTR20250116001), dated 16\u003csup\u003eth\u003c/sup\u003e January 2025. Participants are required to provide signed consent to participate in this study at time of recruitment.\u0026nbsp;Respondents are allowed to withdraw at any point during the study.\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch2\u003eAvailable data and materials\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eThis study is supported by the Community Health Department of Universiti Putra Malaysia.\u003c/p\u003e\n\u003ch2\u003eAuthor\u0026nbsp;Contributions\u003c/h2\u003e\n\u003cp\u003eConceptualisation: KQAH, NAMZ, and NA. Methodology: KQAH, NAMZ, NA and AZFA. Drafted the manuscript: KQAH. Revised and editing the manuscript: KQAH and NAMZ. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003ch2\u003eAcknowledgments\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eWorld Health Organization (WHO). Fact sheets. 2021 [cited 2023 Nov 10]. Infant and young child feeding. Available from: https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding\u003c/li\u003e\n \u003cli\u003eLouis-Jacques AF, Stuebe AM. Enabling Breastfeeding to Support Lifelong Health for Mother and Child. Obstet Gynecol Clin North Am [Internet]. 2020;47(3):363\u0026ndash;81. Available from: https://doi.org/10.1016/j.ogc.2020.04.001\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, et al. Breastfeeding: crucially important, but increasingly challenged in a market-driven world. 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In: Breastfeeding in the workplace. 2015.\u003c/li\u003e\n \u003cli\u003eWorld Health Organization (WHO), United Nations Children\u0026rsquo;s Fund (UNICEF). Breastfeeding counselling: A training course- Trainer\u0026rsquo;s guide. 1993.\u003c/li\u003e\n \u003cli\u003eThe Academy of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol # 8 : Human Milk Storage- Information for home use for full-term infants. Breastfeed Med. 2010;5(3):29\u0026ndash;32.\u003c/li\u003e\n \u003cli\u003eCentre for Disease Control and Prevention (CDC). Breastfeeding. 2022 [cited 2024 Feb 22]. Breastfeeding Report Card: United States, 2022. Available from: https://www.cdc.gov/breastfeeding/data/reportcard.htm\u003c/li\u003e\n \u003cli\u003eBoersma S, Gallagher S. Breastfeeding Protocol: Signs of Effective Breastfeeding. 2019.\u003c/li\u003e\n \u003cli\u003eChipojola R, Chiu HY, Huda MH, Lin YM, Kuo SY. Effectiveness of theory-based educational interventions on breastfeeding self-efficacy and exclusive breastfeeding: A systematic review and meta-analysis. Int J Nurs Stud [Internet]. 2020;109:103675. Available from: https://doi.org/10.1016/j.ijnurstu.2020.103675\u003c/li\u003e\n \u003cli\u003eCenters for Disease Control and Prevention (CDC). Storage And Preparation of Breast Milk [Internet]. 2024. Available from: https://bit.ly/2dxVYLU\u003c/li\u003e\n \u003cli\u003eSiti Mariam A. The Successful Breastfeeding Guide.\u003c/li\u003e\n \u003cli\u003eKumpulan Sokongan Penyusuan Susu Ibu Wilayah Persekutuan Putrajaya dan Kuala Lumpur. Panduan Penyusuan Susu Ibu Bagi Ibu Bekerjaya: edisi keempat. 2013.\u003c/li\u003e\n \u003cli\u003eBahagian Pemakanan Kementerian Kesihatan Malaysia. Manual Pembimbing Penyusuan Susu Ibu: untuk kegunaan kumpulan sokongan penyusuan susu ibu. Kementerian Kesihatan Malaysia. 2019.\u003c/li\u003e\n \u003cli\u003eNoah SM, Ahmad J. Pembinaan Modul: Bagaimana membina modul latihan dan modul akademik. Universiti Putra Malaysia; 2005.\u003c/li\u003e\n \u003cli\u003eWong S, Saddki N, Arifin W, Mohamad N, Roslan N. Alat Penilaian Bahan Pendidikan Pesakit, PEMAT (M) dan Panduan Pengguna: Instrumen untuk menilai kebolehfahaman dan kebolehtindakan bahan pendidikan pesakit bercetak dan pandang-dengar. Kelantan, Malaysia: USM-Pusat Pengajian Sanis Pergigian; 2018.\u003c/li\u003e\n \u003cli\u003eNommsen-Rivers LA, Dewey KG. Development and Validation of the Infant Feeding Intentions Scale. Matern Child Health J. 2009;13:334\u0026ndash;42.\u003c/li\u003e\n \u003cli\u003eJohar N, Mohamad N, Saddki N, Ismail TAT, Sulaiman Z. Intention and actual exclusive breastfeeding practices among women admitted for elective cesarean delivery in kelantan, Malaysia: A prospective cohort study. Med J Malaysia. 2020;75(3):274\u0026ndash;80.\u003c/li\u003e\n \u003cli\u003eChe Muda CM, Tengku Ismail TA, Ab Jalil R, Mohd Hairon S, Sulaiman Z, Johar N. Maternal factors associated with the initiation of exclusive breastfeeding among mothers at one week after delivery in two selected hospitals in Kelantan, Malaysia. Malaysian J Med Sci. 2018;25(4):112\u0026ndash;21.\u003c/li\u003e\n \u003cli\u003eTengku Ismail TA, Sulaiman Z. Reliability and validity of a malay-version questionnaire assessing knowledge of breastfeeding. Malaysian J Med Sci. 2010;17(3):32\u0026ndash;9.\u003c/li\u003e\n \u003cli\u003eDe La Mora A, Russell DW, Dungy CI, Losch M, Dusdieker L. The Iowa infant feeding attitude scale: Analysis of reliability and validity. J Appl Soc Psychol. 1999;29(11):2362\u0026ndash;80.\u003c/li\u003e\n \u003cli\u003eTengku Ismail TA, Muda WAMW, Bakar MI. The extended theory of planned behavior in explaining exclusive breastfeeding intention and behavior among women in Kelantan, Malaysia. Nutr Res Pract. 2016;10(1):49\u0026ndash;55.\u003c/li\u003e\n \u003cli\u003eTsai SY. Impact of a breastfeeding-friendly workplace on an employed mother\u0026rsquo;s intention to continue breastfeeding after returning to work. Breastfeed Med. 2013;8(2):210\u0026ndash;6.\u003c/li\u003e\n \u003cli\u003eDennis C. The Breastfeeding Self‐Efficacy Scale: Psychometric Assessment of the Short Form. J Obstet Gynecol Neonatal Nurs. 2003;32:734\u0026ndash;44.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-health-population-and-nutrition","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"johp","sideBox":"Learn more about [Journal of Health, Population and Nutrition](http://jhpn.biomedcentral.com/)","snPcode":"41043","submissionUrl":"https://submission.nature.com/new-submission/41043/3","title":"Journal of Health, Population and Nutrition","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Exclusive breastfeeding intention, working mothers, randomised control trial, intervention, health education","lastPublishedDoi":"10.21203/rs.3.rs-7153570/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7153570/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 crucial for a child’s health, providing numerous benefits such as improved disease resistance and intelligence. Despite global efforts, exclusive breastfeeding rates remain a concern. Maternal employment is a well-documented, significant barrier, as working mothers often face challenges in sustaining exclusive breastfeeding. Studies have shown that prenatal intention strongly influences breastfeeding practices. Thus, an intervention module in improving exclusive breastfeeding intention targeting knowledge, attitude, subjective norm, and perceived control is necessary. This study aims to develop, validate, and evaluate a theory-based intervention programme to improve exclusive breastfeeding intention among working mothers in Malacca, Malaysia. This randomised controlled trial, guided by CONSORT, will assess the intervention's impact on knowledge, attitude, subjective norm, perceived control, and exclusive breastfeeding intention among working mothers.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis two-arm randomised controlled trial will allocate pregnant women to either the intervention or control group by cluster, with each cluster defined as a government health clinic. This study will be conducted over a 30-month period, encompassing planning, theory-based module development, implementation, and effectiveness evaluation. All pregnant women who meet the inclusion criteria will be included. A total of 216 participants are needed for hypothesis testing. Participants will be randomly allocated into two parallel groups at a 1:1 ratio (n=108 per group) to receive either the health education intervention or standard routine care. The primary outcome is exclusive breastfeeding intention, and the secondary outcomes are knowledge, attitude, subjective norms, and perceived behaviour control regarding exclusive breastfeeding, which will be measured at baseline, 1 month, and 4 months postnatal.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study is the first trial to assess the effectiveness of a theory-based health education intervention in improving exclusive breastfeeding intention among working mothers in Malaysia. Furthermore, this study will provide evidence on the effectiveness of the intervention delivered throughout both the antenatal and postnatal periods within this region.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics and dissemination\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study protocol was approved by the Medical Research and Ethics Committee Ministry of Health Malaysia (NMRR ID-24-02852-NQU (IIR) on 23\u003csup\u003erd\u003c/sup\u003e December 2024.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThai Clinical Trials Registry, TCTR20250116001. Registered on 16\u003csup\u003eth\u003c/sup\u003e January, 2025.\u003c/p\u003e","manuscriptTitle":"Effect Of Theory-Based Health Education Intervention In Improving Exclusive Breastfeeding Intention Among Working Mothers: A Study Protocol For A Cluster Randomised Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-27 05:35:55","doi":"10.21203/rs.3.rs-7153570/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-09-17T22:45:47+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-09-17T16:10:16+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"134721033365798719255987185123231505138","date":"2025-09-17T15:45:17+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-08-18T02:19:22+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"25048121486416035700071504776337152981","date":"2025-08-17T00:44:01+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-08-14T10:07:48+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-07-23T15:36:18+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-07-23T15:35:54+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Health, Population and Nutrition","date":"2025-07-18T03:47:14+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-health-population-and-nutrition","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"johp","sideBox":"Learn more about [Journal of Health, Population and Nutrition](http://jhpn.biomedcentral.com/)","snPcode":"41043","submissionUrl":"https://submission.nature.com/new-submission/41043/3","title":"Journal of Health, Population and Nutrition","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"9e8d4d18-157b-45f9-bffc-2896cd2dec2e","owner":[],"postedDate":"August 27th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-03-02T16:09:36+00:00","versionOfRecord":[],"versionCreatedAt":"2025-08-27 05:35:55","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7153570","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7153570","identity":"rs-7153570","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}