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Aims: To assess what is known about the risks associated with errors in reconstituting the present generation of infant formula feeds, and to examine which methods are likely to be [...]

Background Guidance based on a systematic assessment of the evidence base has become a fundamental tool in the cycle of evidence-based practice and policy internationally. The process of moving from the formal evidence base derived from research studies to the formation and agreement of recommendations is however acknowledged to be problematic, especially in public health; and the involvement of practitioners, service commissioners and service users in that process is both important and methodologically challenging. Aim To test a structured process of developing evidence-based recommendations in public health while involving a broad constituency of practitioners, service commissioners and service user representatives. Methods As part of the development of national public health recommendations to promote and support breastfeeding in England, the methodological challenges of involving stakeholders were examined and addressed. There were three main stages: (i) an assessment of the formal evidence base (210 studies graded); (ii) electronic and fieldwork-based consultation with practitioners, service commissioners and service user representatives (563 participants), and an in-depth analytical consultation in three 'diagonal slice' workshops (89 participants); (iii) synthesis of the previous two stages. Results and conclusions The process resulted in widely agreed recommendations together with suggestions for implementation. It was very positively evaluated by participants and those likely to use the recommendations. Service users had a strong voice throughout and participated actively. This mix of methods allowed a transparent, accountable process for formulating recommendations based on scientific, theoretical, practical and expert evidence, with the added potential to enhance implementation. [ABSTRACT FROM AUTHOR]

The midwifery profession is increasingly applying the results of evidence-based research findings. Several researchers were asked if they would answer questions regarding the essential research skills necessary for midwives, the relevance of applying valid evidence to practice, and concerns regarding evidence-based practice overall. The objectives were to share expert researchers' responses that could be used by educators to help introductory midwifery students understand the importance of developing skills in assessing 'the best evidence' and to stimulate interactive discussion in the classroom. Consideration of the expert opinions stimulated student thinking on the relation of evidence-based findings to practice in an exciting approach characterized by inquiry and debate, which got favorable responses and evaluations from the students. [ABSTRACT FROM AUTHOR]

Background: Trauma to the genital tract commonly occurs at birth, and can cause short- and long-term morbidity. Clinical measures to reduce its occurrence have not been fully identified. Methods: A systematic review of the English language literature was conducted to describe the current state of knowledge on reduction of genital tract trauma before planning a large randomized controlled trial of ways to prevent such trauma. Randomized trials and other published reports were identified from relevant databases and hand searches. Studies were reviewed and assessed using a structured format. Results: A total of 77 papers and chapters were identified and placed into 5 categories after critical review: 25 randomized trials, 4 meta-analyses, 4 prospective studies, 36 retrospective studies, and 8 descriptions of practice from textbooks. The available evidence is conclusive in favor of restricted use of episiotomy. The contribution of maternal characteristics and attitudes to intact perineum has not been investigated. Several other topics warrant further study, including maternal position, style of pushing, and antenatal perineal massage. Strong opinions and sparse data exist regarding the role of hand maneuvers by the birth attendant for perineal management and birth of the baby. This became the topic of the planned randomized controlled trial, which was completed; results will be published soon. Conclusions: The case for restricting the use of episiotomy is conclusive. Several other clinical factors warrant investigation, including the role of hand maneuvers by the birth attendant in preventing birth trauma. A large randomized controlled trial will report on this topic. [ABSTRACT FROM AUTHOR]

Focuses on the long-term public health benefits of breastfeeding in Great Britain. Means of promoting and supporting breastfeeding duration; Importance of training and practice change for health professionals and lay counselors; Ways of raising breastfeeding rates among groups.

Breastfeeding is not simply a technical or practical task but is part of the transition to motherhood, the relationship between mother and baby and the everyday experience of living with a new baby. Discussion of breastfeeding must therefore include the individual's personal and social context. This paper explores how women in England who have chosen to breastfeed their baby accomplish this task during the early stages of motherhood and the relative weight attached to different factors, which impinge on decision-making. Our findings, based on observing 158 interactions between breastfeeding women and midwives or health visitors from one Primary Care Trust in the north of England, UK, and in-depth interviews with a sample of 22 of these women, illustrate the dynamic between breastfeeding, becoming and being a 'good mother' and merging multiple identities as they embrace motherhood. In this context, the value attached to breastfeeding as synonymous with being a 'good mother' is questioned. In managing the balance between ensuring a healthy, contented baby and the reality of their daily lives, women negotiate the moral minefield that defines 'good mothering' and the diverse conceptions and influences that shape it-including health professionals, their social networks and the wider social and structural context of their lives. The implications for policy and practice are discussed. [ABSTRACT FROM AUTHOR]

The Looking at Infant Feeding Today (LIFT) study examined the factors underlying the infant feeding choices of first-time mothers in the Leeds and Bradford areas of England experiencing material hardship, with a view to informing interventions aimed at increasing breastfeeding uptake amongst this group. This short report describes the novel methodology used to obtain data from a sample of pregnant women who are traditionally 'hard-to-reach' in deprived areas. This involved the use of trusted individuals such as midwives and multilingual health workers. A total of 449 women were approached; 441 (91.5%) agreed to participate and 303 returned completed questionnaires. Whilst 285 participants self-completed, 18 opted for interviewer assistance provided by a trained multilingual health worker. Feeding method up to 10 days after birth was obtained from the hospital records of 248 women (82.4% of eligible returns), and self-reported feeding method at six weeks was obtained from 273 women (90.7% of eligible returns). The study succeeded in obtaining data from a relatively deprived and hard-to-reach sample, with adequate numbers of participants in the subgroups of interest (teenage, left full time education age 16 or younger, household receiving income support or job seekers allowance, Asian or African-Caribbean). [ABSTRACT FROM AUTHOR]

Aim: The aim of the study was to explore the determinants of time to presentation of women with breast cancer symptoms within a rural setting in Kenya., Design: A critical ethnographic study., Methods: Data were collected between July 2019 and April 2020 using semi-structured interviews and focus groups with 12 women and 23 disclosure recipients, respectively. Interviews and focus group discussions were audio recorded, transcribed verbatim, translated into English and thematically analysed. Further analysis using an intersectional lens added new insights into the data. Ethics approval was obtained in both Kenya and United Kingdom., Results: Participants narrated their experiences from the time they self-discovered breast cancer symptoms to the time they first came into contact with a healthcare professional. The core themes identified included local cancer knowledge, embodied experience, women's responses, social networks, cultural cancer schemas, gendered social structures and healthcare system experiences., Conclusion: The findings revealed that symptomatic women predominantly faced multiple intersecting barriers to timely presentation. The key drivers of timeliness to presentation of women with breast cancer symptoms were identified. Several proximal and distal determinants, including economic, social, psychological and cultural determinants intersected to shape women's timeliness to symptomatic presentation., Impact: This study identified intersectional structural determinants to timely symptomatic presentation of women with breast cancer symptoms. The findings have global health implications for social inequalities in female breast cancer and may inform the development of intersectional interventions to promote timely symptomatic presentation. Furthermore, this study identified an additional interval, precursory interval and revision of the Model of pathway to treatment may be needed should this interval be validated by future studies., Patient or Public Contribution: To ensure the interview guides were culturally sensitive, they were co-designed with a female breast cancer survivor, nurses providing reproductive health care to women and a bilingual expert. Both women and disclosure recipients participated in scheduling for the interviews, including the mutually agreeable days and time. Participants were frequently contacted during data analysis and report writing to clarify meaning of certain words or pieces of data., (© 2023 The Authors. Journal of Advanced Nursing published by John Wiley & Sons Ltd.)

The context of healthcare and of healthcare education has radically changed as a result of the Covid-19 pandemic. To identify positive strategies for midwifery education in this context, five case studies from the UK and beyond were conducted using an appreciative enquiry approach, from the perspectives of students, the maternity services, cross-university collaboration, and digital learning. A health system analysis was used to identify strategies to cope, adapt, and transform for the future, at the levels of individuals, teams, and the whole system. Findings showed that the implementation of effective responses was possible. Responding effectively and rapidly to a shock as profound as this pandemic requires courageous, respectful, evidence-based, innovative, collaborative, cross-sectoral working and leadership across education institutions, practice settings, the regulator, government, and with students themselves. Pre-existing trusting relationships and collaborative systems supported rapid responses. Effective digital learning requires a pro-active, student-centred approach, and addressing the problems of inequitable access to equipment and space. Joint problem-solving and focussing on the key outcomes that matter contribute to developing successful strategies and robust processes. The pandemic provides an opportunity for student midwives to be re-imagined as essential members of midwifery teams and not 'just students'. Transformative actions identified include whole-system working, tackling longstanding problems including racism, poverty, prejudice, and systemic discrimination, and keeping students at the heart of the education system., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020. Published by Elsevier Ltd.)

Background: Breastfeeding duration has declined in the Kingdom of Saudi Arabia (KSA) in recent decades, although accurate national data about different breastfeeding indicators by infant age are lacking. This qualitative study, the first in KSA, aimed to understand the factors affecting mothers' decisions and experiences regarding any breastfeeding practices., Methods: A qualitative phenomenological approach was used to investigate mothers' experiences of breastfeeding. Non-probability convenience sampling and snowballing strategies were designed to recruit participants. Semi-structured interviews were conducted with 16 mothers, from two hospitals and three primary health clinics in Al-Madinah city, from December 2017 to March 2018. Interpretative phenomenological analysis was the analysis framework., Results: Three themes were identified: 1) 'Up against the system': policies, staff and systems were the main barriers to exclusive breastfeeding; 2) 'Social support and negativity': family support in the first 40 postpartum days protected breastfeeding continuation and was highly appreciated, but negative comments limited breastfeeding practices thereafter; and 3) 'Managing tensions': mothers' religious beliefs about breastfeeding boosted their decisions; however, the challenge of managing tensions influenced mothers to stop breastfeeding earlier than they wished. The study revealed that mothers had no doubts about wanting to breastfeed their babies; but continuation was adversely affected by unhelpful hospital policies and staff actions, the lack of ongoing social support, and by others people's negativity, rather than by the mothers' own views. Stopping breastfeeding earlier than planned was a complex decision for most mothers. However, mothers said that they intended to breastfeed their next baby successfully., Conclusions: Healthcare professionals (maternity staff, paediatricians and pharmacists) need education and training to support exclusive breastfeeding effectively. Increasing the number of hospitals with Baby Friendly Hospital Initiative accreditation, which includes staff practice changes, is needed to protect and support exclusive breastfeeding. Ongoing professional and peer support, and improving conditions at workplaces and universities, are needed to help mothers to continue breastfeeding successfully. Effective, coordinated national policies can support mothers' decisions in relation to breastfeeding. Such changes will reduce the tensions experienced by women and help them to achieve their breastfeeding goals and to breastfeed for longer.

Importance: Breast milk substitutes (BMS) are important nutritional products evaluated in clinical trials. Concerns have been raised about the risk of bias in BMS trials, the reliability of claims that arise from such trials, and the potential for BMS trials to undermine breastfeeding in trial participants. Existing clinical trial guidance does not fully address issues specific to BMS trials., Objectives: To establish new methodological criteria to guide the design, conduct, analysis, and reporting of BMS trials and to support clinical trialists designing and undertaking BMS trials, editors and peer reviewers assessing trial reports for publication, and regulators evaluating the safety, nutritional adequacy, and efficacy of BMS products., Design, Setting, and Participants: A modified Delphi method was conducted, involving 3 rounds of anonymous questionnaires and a face-to-face consensus meeting between January 1 and October 24, 2018. Participants were 23 experts in BMS trials, BMS regulation, trial methods, breastfeeding support, infant feeding research, and medical publishing, and were affiliated with institutions across Europe, North America, and Australasia. Guidance development was supported by an industry consultation, analysis of methodological issues in a sample of published BMS trials, and consultations with BMS trial participants and a research ethics committee., Results: An initial 73 criteria, derived from the literature, were sent to the experts. The final consensus guidance contains 54 essential criteria and 4 recommended criteria. An 18-point checklist summarizes the criteria that are specific to BMS trials. Key themes emphasized in the guidance are research integrity and transparency of reporting, supporting breastfeeding in trial participants, accurate description of trial interventions, and use of valid and meaningful outcome measures., Conclusions and Relevance: Implementation of this guidance should enhance the quality and validity of BMS trials, protect BMS trial participants, and better inform the infant nutrition community about BMS products.

Competing Interests: Declaration of Competing Interest none declared

Background: Research funders in Canada and abroad have made substantial investments in supporting collaborative research approaches to generating and translating knowledge as it is believed to increase knowledge use. Canadian health research funders have advocated for the use of integrated knowledge translation (IKT) in health research, however, there is limited research around how IKT compares to other collaborative research approaches. Our objective was to better understand how IKT compares with engaged scholarship, Mode 2 research, co-production and participatory research by identifying the differences and similarities among them in order to provide conceptual clarity and reduce researcher and knowledge user confusion about these common approaches., Methods: We employed a qualitative descriptive method using interview data to better understand experts' perspectives and experiences on collaborative research approaches. Participants' responses were analysed through thematic analysis to elicit core themes. The analysis was centred around the concept of IKT, as it is the most recent approach; IKT was then compared and contrasted with engaged scholarship, Mode 2 research, co-production and participatory research. As this was an iterative process, data triangulation and member-checking were conducted with participants to ensure accuracy of the emergent themes and analysis process., Results: Differences were noted in the orientation (i.e. original purpose), historical roots (i.e. disciplinary origin) and partnership/engagement (i.e. role of partners etc.). Similarities among the approaches included (1) true partnerships rather than simple engagement, (2) focus on essential components and processes rather than labels, (3) collaborative research orientations rather than research methods, (4) core values and principles, and (5) extensive time and financial investment. Core values and principles among the approaches included co-creation, reciprocity, trust, fostering relationships, respect, co-learning, active participation, and shared decision-making in the generation and application of knowledge. All approaches require extensive time and financial investment to develop and maintain true partnerships., Conclusions: This qualitative study is the first to systematically synthesise experts' perspectives and experiences in a comparison of collaborative research approaches. This work contributes to developing a shared understanding of collaborative research approaches to facilitate conceptual clarity in use, reporting, indexing and communication among researchers, trainees, knowledge users and stakeholders to advance IKT and implementation science.

Purpose: Behaviour change interventions are more likely to be effective if they are sensitive to contextual determinants of behaviour. Delayed presentation of women with breast symptoms is a concern for both high-income and low- and medium-income countries. Our aim was to integrate evidence on determinants of time to presentation of women with breast symptoms with complementary evidence on interventions for promoting early presentation., Methods: A systematic review was conducted according to PRISMA guidelines. Ten electronic databases were searched for relevant articles published between 1985 to May 2019. Pre-defined selection criteria were applied to retrieved records. Evidence on interventions, and on determinants were integrated through sequential explanatory synthesis design., Results: Of the 4185 documents retrieved, 11 intervention studies and 10 determinants studies were included in the synthesis. Overall, evidence on interventions is of low quality, while that on determinants is of medium quality. Intervention studies were mostly individual-level with almost exclusive focus on breast cancer awareness among postmenopausal women in high-income countries. Synthesis of evidence on determinants resulted in 10 domains. Juxtaposing the evidence on determinants of time to presentation of women with breast symptoms with that of the interventions to promote early presentation shows a mismatch between them., Conclusions: Whilst there is strong evidence that women with breast symptoms face multi-level influences to presentation, current interventions have focused almost exclusively on breast cancer awareness in high-income countries. High quality multi-level interventions are required to promote early presentation of symptomatic women in different socio-cultural and economic settings., Competing Interests: Declaration of competing interests The authors declare that there is no conflicts of interest in relation to this work., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Good quality midwifery care has the potential to reduce both maternal and newborn mortality and morbidity in high, low, and lower-middle income countries (LMIC) and needs to be underpinned by effective education. There is considerable variation in the quality of midwifery education provided globally., Objective: To determine what are the most efficient and effective ways for LMICs to conduct pre-service and in-service education and training in order to adequately equip care providers to provide quality maternal and newborn care., Design: Rapid Systematic Evidence Review METHODS: A systematic search of the following databases was conducted: Medline, CINAHL, LILACs, PsycInfo, ERIC, and MIDIRs. Studies that evaluated the effects of pre-service and in-service education that were specifically designed to train, educate or upskill care providers in order to provide quality maternal and newborn care were included. Data was extracted and presented narratively., Findings: Nineteen studies were included in the review. Of these seven were evaluations of pre-service education programmes and 12 were evaluations of in-service education programmes. Whilst studies demonstrated positive effects on knowledge and skills, there was a lack of information on whether this translated into behaviour change and positive effects for women and babies. Moreover, the level of the evidence was low and studies often lacked an educational framework and theoretical basis. Mapping the skills taught in each of the programmes to the Quality Maternal and Newborn Care framework (Renfrew et al., 2014) identified that interventions focused on very specific or individual clinical skills and not on the broader scope of midwifery., Key Conclusions: There is a very limited quantity and quality of peer reviewed published studies of the effectiveness of pre service and in service midwifery education in LMICs; this is at odds with the importance of the topic to survival, health and well-being. There is a preponderance of studies which focus on training for specific emergencies during labour and birth. None of the in-service programmes considered the education of midwives to international standards with the full scope of competencies needed. There is an urgent need for the development of theoretically informed pre-service and in-service midwifery education programmes, and well-conducted evaluations of such programmes. Upscaling quality midwifery care for all women and newborn infants is of critical importance to accelerate progress towards Sustainable Development Goal 3. Quality midwifery education is an essential pre-requisite for quality care. To deliver SDG 3, the startling underinvestment in midwifery education identified in this review must be reversed., (Copyright © 2019. Published by Elsevier Ltd.)

Background: Whilst marriage has been repeatedly identified in the literature as an HIV risk factor amongst Southern African women, not much is known about women's perception of their role, experiences and strategies used to address HIV risks in the context of a marriage. Aims: The aim of the study was to synthesise perceptions, experiences and strategies of married Southern African women in the prevention of HIV. Methods: A systematic review of qualitative studies was conducted. Three electronic databases (Medline, Cinahl and PsycINFO) were systematically searched to identify relevant literature. The meta-synthesis process followed Sandelowski and Barroso's [2007. Handbook for Synthesizing Qualitative Research. Springer Publishing Company] recommendations. Results: Of 7 609 papers, 15 were included in the review. The quality of the included studies was variable. In the final synthesis stage, three broad analytic themes emerged: contextual background, cues to preventive behaviour, and HIV prevention strategies. Implications: Findings were used to develop a conceptual framework for studying HIV/AIDS prevention experiences of married Southern African women.

Background: Various theories provide guidance on implementing, sustaining and evaluating innovations within healthcare. There has been less attention given, however, to personal theories drawn from practice and the expertise of managers and front-line staff is a largely untapped resource. In this paper, we share learning from experienced improvement organisations to provide a conceptual level explanation of the conditions necessary to facilitate and sustain improvement at scale., Methods: Staff (n=42) from three leading change organisations in the UK, spanning health, education and social care, took part in three consultation meetings with the aim of sharing knowledge about sustaining large-scale change. This included one government organisation, one National Health Service Board and one large charity organisation. Using a participatory grounded theory approach, the workshops resulted in a co-created theory., Results: The theory of Motivating Change describes the psychosocial-structural conditions for large-scale, sustained change from the perspectives of front-line staff. The theory posits that change is more likely to be sustained at scale if there is synergy between staff's perceived need and desire for improvement, and the extrinsic motivators for change. Witnessing effective change is motivating for staff and positive outcomes provide a convincing argument for the need to sustain improvement activity. As such, evidence of change becomes evidence for change. This is only possible when there is a flow of trust within organisations that capitalises on positive peer pressure and suppresses infectious negativity. When these conditions are in place, organisations can generate self-proliferating improvement., Conclusions: The theory of Motivating Change has been co-created with staff and offers a useful explanation and guide for others involved in change work that capitalises on front-line expertise., Competing Interests: Competing interests: None declared.

The importance of breastfeeding is clear. However, global action to support breastfeeding is hindered by the lack of reliable standard data, which continues to impede progress. Routinely collected data can monitor the effectiveness of health policy, evaluate interventions, and enhance international research collaboration and comparisons. Use of routine data to support effective public health initiatives such as smoking cessation has been demonstrated. However, the data collected about infant feeding practices worldwide is inconsistent in timing, methods, definitions, detail, storage, and consistency. Improvements to the reach and quality of routinely collected data about infant feeding are needed to strengthen the global evidence and policy base. An international collaborative effort is called for to progress this., (© 2018 John Wiley & Sons Ltd.)

Importance: Although breastfeeding has a positive effect on an infant's health and development, the prevalence is low in many communities. The effect of financial incentives to improve breastfeeding prevalence is unknown., Objective: To assess the effect of an area-level financial incentive for breastfeeding on breastfeeding prevalence at 6 to 8 weeks post partum., Design, Setting, and Participants: The Nourishing Start for Health (NOSH) trial, a cluster randomized trial with 6 to 8 weeks follow-up, was conducted between April 1, 2015, and March 31, 2016, in 92 electoral ward areas in England with baseline breastfeeding prevalence at 6 to 8 weeks post partum less than 40%. A total of 10 010 mother-infant dyads resident in the 92 study electoral ward areas where the infant's estimated or actual birth date fell between February 18, 2015, and February 17, 2016, were included. Areas were randomized to the incentive plus usual care (n = 46) (5398 mother-infant dyads) or to usual care alone (n = 46) (4612 mother-infant dyads)., Interventions: Usual care was delivered by clinicians (mainly midwives, health visitors) in a variety of maternity, neonatal, and infant feeding services, all of which were implementing the UNICEF UK Baby Friendly Initiative standards. Shopping vouchers worth £40 (US$50) were offered to mothers 5 times based on infant age (2 days, 10 days, 6-8 weeks, 3 months, 6 months), conditional on the infant receiving any breast milk., Main Outcomes and Measures: The primary outcome was electoral ward area-level 6- to 8-week breastfeeding period prevalence, as assessed by clinicians at the routine 6- to 8-week postnatal check visit. Secondary outcomes were area-level period prevalence for breastfeeding initiation and for exclusive breastfeeding at 6 to 8 weeks., Results: In the intervention (5398 mother-infant dyads) and control (4612 mother-infant dyads) group, the median (interquartile range) percentage of women aged 16 to 44 years was 36.2% (3.0%) and 37.4% (3.6%) years, respectively. After adjusting for baseline breastfeeding prevalence and local government area and weighting to reflect unequal cluster-level breastfeeding prevalence variances, a difference in mean 6- to 8-week breastfeeding prevalence of 5.7 percentage points (37.9% vs 31.7%; 95% CI for adjusted difference, 2.7% to 8.6%; P < .001) in favor of the intervention vs usual care was observed. No significant differences were observed for the mean prevalence of breastfeeding initiation (61.9% vs 57.5%; adjusted mean difference, 2.9 percentage points; 95%, CI, -0.4 to 6.2; P = .08) or the mean prevalence of exclusive breastfeeding at 6 to 8 weeks (27.0% vs 24.1%; adjusted mean difference, 2.3 percentage points; 95% CI, -0.2 to 4.8; P = .07)., Conclusions and Relevance: Financial incentives may improve breastfeeding rates in areas with low baseline prevalence. Offering a financial incentive to women in areas of England with breastfeeding rates below 40% compared with usual care resulted in a modest but statistically significant increase in breastfeeding prevalence at 6 to 8 weeks. This was measured using routinely collected data., Trial Registration: International Standard Randomized Controlled Trial Registry: ISRCTN44898617.

Background: A cluster randomised controlled trial of a financial incentive for breastfeeding conducted in areas with low breastfeeding rates in the UK reported a statistically significant increase in breastfeeding at 6-8 weeks. In this paper we report an analysis of interviews with women eligible for the scheme, exploring their experiences and perceptions of the scheme and its impact on breastfeeding to support the interpretation of the results of the trial., Methods: Semi-structured interviews were carried out with 35 women eligible for the scheme during the feasibility and trial stages. All interviews were recorded and verbatim transcripts analysed using a Framework Analysis approach., Results: Women reported that their decisions about infant feeding were influenced by the behaviours and beliefs of their family and friends, socio-cultural norms and by health and practical considerations. They were generally positive about the scheme, and felt valued for the effort involved in breastfeeding. The vouchers were frequently described as a reward, a bonus and something to look forward to, and helping women keep going with their breastfeeding. They were often perceived as compensation for the difficulties women encountered during breastfeeding. The scheme was not thought to make a difference to mothers who were strongly against breastfeeding. However, women did believe the scheme would help normalise breastfeeding, influence those who were undecided and help women to keep going with breastfeeding and reach key milestones e.g. 6 weeks or 3 months., Conclusions: The scheme was acceptable to women, who perceived it as rewarding and valuing them for breastfeeding. Women reported that the scheme could raise awareness of breastfeeding and encourage its normalisation. This provides a possible mechanism of action to explain the results of the trial., Trial Registration: The trial is registered with the ISRCTN registry, number 44898617 , https://www.isrctn.com.