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Background: Emerging evidence suggests that positive impacts can be generated when digital health interventions are designed to be responsive to the cultural and socioeconomic context of their intended audiences., Objective: This narrative review aims to synthesize the literature about the cultural adaptation of digital health interventions. It examines how concepts of culture and context feature in design and development processes, including the methods, models, and content of these interventions, with the aim of helping researchers to make informed decisions about how to approach cultural adaptation in digital health., Methods: Literature searches for this narrative review were conducted across 4 databases. Following full-text article screening by 2 authors, 16 studies of interventions predominantly focused on the self-management of health were selected based on their detailed focus on the process of cultural adaptation. Key considerations for cultural adaptation were identified and synthesized through a qualitative narrative approach, enabling an integrative and in-depth understanding of cultural adaptation., Results: The literature demonstrates varying approaches and levels of cultural adaptation across stages of intervention development, involving considerations such as the research ethos orienting researchers, the methodologies and models used, and the resultant content adaptations. In relation to the latter, culturally appropriate and accessible user interface design and translation can be seen as particularly important in shaping the level of adaptation., Conclusions: Optimizing cultural adaptation involves linking culture with other contextual factors such as economic conditions and social systems to ensure accessibility and the sustained use of digital health interventions. Culturally humble approaches that use the involvement of a broad range of participants, experts, and other stakeholders are demonstrated to spark vital insights for content development, implementation, and evaluation., (©Aila Naderbagi, Victoria Loblay, Iqthyer Uddin Md Zahed, Mahalakshmi Ekambareshwar, Adam Poulsen, Yun J C Song, Laura Ospina-Pinillos, Michael Krausz, Mostafa Mamdouh Kamel, Ian B Hickie, Haley M LaMonica. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 09.07.2024.)

Objective: The Thrive by Five app promotes positive interactions between children and parents, extended family, and trusted community members that support optimal socio-emotional and cognitive development in the early years. This article aims to describe the protocol for a prospective mixed-methods multi-site study evaluating Thrive by Five using surveys, interviews, workshops, audio diaries from citizen ethnographers and app usage data., Methods: The study activities and timelines differ by site, with an extensive longitudinal evaluation being conducted at two sites and a basic evaluation being conducted at five sites. The learnings from the more comprehensive evaluations inform the iterative research and development processes while also ensuring ongoing evaluation of usability, acceptability and effectiveness of the app and its content across varying contexts. The study evaluates: (1) the impact of the Thrive by Five content on caregiver knowledge, behaviours, attitudes and confidence; (2) how the content changes relationships at the familial, community and system level; (3) how cultural and contextual factors influence content engagement and effectiveness and (4) the processes that facilitate or disrupt the success of the implementation and dissemination., Results: All in-country partners have been identified and data collection has been completed in Indonesia, Malaysia, Afghanistan, Kyrgyzstan, Uzbekistan, Namibia and Cameroon., Conclusions: Very few digital health solutions have been trialled for usability and effectiveness in diverse cultural contexts. By combining quantitative, qualitative, process and ethnographic methodologies, this innovative study informs the iterative and ongoing optimisation of the cultural and contextual sensitivity of the Thrive by Five content and the processes supporting implementation and dissemination., Competing Interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: IBH is supported by a NHMRC L3 Investigator Grant (GNT2016346). He is the co-director, Health and Policy at the Brain and Mind Centre (BMC) University of Sydney. The BMC operates an early-intervention youth service at Camperdown under contract to headspace. He is the chief scientific advisor to, and a 3.2% equity shareholder in, InnoWell Pty Ltd which aims to lead transformation of mental health services internationally through the use of innovative technologies. VL is a board member for Matana Foundation, a philanthropic organisation that provides funding to programmes for disadvantaged young people in Australia. She does not receive any financial benefit for this role. No other authors have competing interests., (© The Author(s) 2024.)

Part of the appeal of digital health interventions, including mHealth, is the potential for greater reach in places where conventional health promotion is hampered by geographical, financial or social barriers. Yet, 'engagement' - typically understood as user experience and interactions with technology - remains a persistent challenge, particularly in places where technology access or familiarity with technology is limited. We undertook an evaluation of a childrearing app to promote socioemotional and cognitive development in early childhood across the world. In this article, we present findings from qualitative research on app rollout in Indonesia, the first of numerous low- and middle-income countries targeted by the app. We draw on systems theory and complexity thinking to broaden the lens of 'engagement' beyond individual users to encompass collective systems (families and communities), exploring how the intervention was harnessed to meet local contextual needs. The qualitative research involved semi-structured interviews, workshops and audio diaries with 57 diverse stakeholders, including Indonesian parents, caregivers, and collaborators involved in funding, development, and dissemination of the app. We observed the importance of social connection, sense-making, and interactive learning for enhancing engagement with the app and its messages. Enthusiastic users, strongly linked across community networks (e.g. kindergarten teachers), improvised dissemination strategies to facilitate uptake. Interactive learning that tapped into familiar social structures (e.g. intergenerational hierarchies) was crucial for engagement. Understanding ways the app failed to tap into structures of social connection served to highlight the need to embed strategies to support collective engagement., Competing Interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: IBH is the Co-Director, Health and Policy at the Brain and Mind Centre (BMC) University of Sydney. The BMC operates an early-intervention youth service at Camperdown under contract to headspace. He is the Chief Scientific Advisor to, and a 3.2% equity shareholder in, InnoWell Pty Ltd., which aims to transform mental health services through the use of innovative technologies. VL is a board member for Matana Foundation, a philanthropic organisation that provides funding to programs for disadvantaged young people in Australia. She does not receive any financial benefit for this role. No other authors report competing interests., (© The Author(s) 2023.)

Background: Optimal child-rearing practices can help mitigate the consequences of detrimental social determinants of health in early childhood. Given the ubiquity of personal digital technologies worldwide, the direct delivery of evidence-based information about early childhood development holds great promise. However, to make the content of these novel systems effective, it is crucial to incorporate place-based cultural beliefs, traditions, circumstances, and value systems of end users., Objective: This paper describes the iterative approach used to develop the Thrive by Five child-rearing app in collaboration with Afghan parents, caregivers (eg, grandparents, aunts, and nannies), and subject matter experts (SMEs). We outline how co-design methodologies informed the development and cultural contextualization of content to meet the specific needs of Afghan parents and the content was tested and refined in collaboration with key Afghan stakeholders., Methods: The preliminary content was developed based on a comprehensive literature review of the historical and sociocultural contexts in Afghanistan, including factors that influence child-rearing practices and early childhood development. After an initial review and refinement based on feedback from SMEs, this content was populated into a beta app for testing. Overall, 8 co-design workshops were conducted in July and August 2021 and February 2022 with 39 Afghan parents and caregivers and 6 SMEs to collect their feedback on the app and its content. The workshops were audio recorded and transcribed; detailed field notes were taken by 2 scribes. A theoretical thematic analysis using semantic codes was conducted to inform the refinement of existing content and development of new content to fulfill the needs identified by participants., Results: The following 4 primary themes were identified: child-rearing in the Afghan sociocultural context, safety concerns, emotion and behavior management, and physical health and nutrition. Overall, participants agreed that the app had the potential to deliver valuable information to Afghan parents; however, owing to the volatility in the country, participants recommended including more activities that could be safely done indoors, as mothers and children are required to spend most of their time at home. Additionally, restrictions on public engagement in music required the removal of activities referencing singing that might be performed outside the home. Further, activities to help parents reduce their children's screen time, promote empathy, manage emotions, regulate behavior, and improve physical health and nutrition were requested., Conclusions: Direct engagement with Afghan parents, caregivers, and SMEs through co-design workshops enabled the development and refinement of evidence-based, localized, and contextually relevant child-rearing activities promoting healthy social, emotional, and cognitive development during the first 5 years of children's lives. Importantly, the content was adapted for the ongoing conflict in Afghanistan with the aim of empowering Afghan parents and caregivers to support their children's developmental potential despite the security concerns and situational stressors., (©Haley M LaMonica, Jacob J Crouse, Yun J C Song, Mafruha Alam, Chloe E Wilson, Gabrielle Hindmarsh, Adam Yoon, Kelsie A Boulton, Mahalakshmi Ekambareshwar, Victoria Loblay, Jakelin Troy, Mujahid Torwali, Adam J Guastella, Richard B Banati, Ian B Hickie. Originally published in JMIR Formative Research (https://formative.jmir.org), 23.08.2023.)

Objective: Many children in low-income and middle-income countries are disadvantaged in achieving early developmental potential in childhood as they lack the necessary support from their surroundings, including from parents and caregivers. Digital technologies, such as smartphone apps, coupled with iterative codesign to engage end-users in the technology-delivered content development stages, can help overcome gaps in early child development (ECD). We describe the iterative codesign and quality improvement process that informs the development of content for the Thrive by Five International Program , localised for nine countries in Asia and Africa., Design: Between 2021 and 2022, an average of six codesign workshops in each country were conducted in Afghanistan, Indonesia, Kyrgyzstan, Uzbekistan, Cameroon, the Democratic Republic of the Congo, Ethiopia, Kenya and Namibia. Participants A total of 174 parents and caregivers and 58 in-country subject matter experts participated and provided feedback to refine and inform the cultural appropriateness of the Thrive by Five app and its content. Detailed notes from the workshops and written feedback were coded and analysed using established thematic techniques., Results: Four themes emerged from the codesign workshops: local realities, barriers to positive parenting, child development and lessons learnt about the cultural context. These themes, as well as various subthemes, informed content development and refinement. For example, childrearing activities were requested and developed to promote inclusion of families from diverse backgrounds, encourage best parenting practices, increase engagement of fathers in ECD, address parents' mental well-being, educate children about cultural values and help bereaved children with grief and loss. Also, content that did not align with the laws or culture of any country were removed., Conclusions: The iterative codesign process informed the development of a culturally relevant app for parents and caregivers of children in the early years. Further evaluation is required to assess user experience and impact in real world settings., Competing Interests: Competing interests: IBH is the codirector, Health and Policy at the Brain and Mind Centre at the University of Sydney. The Brain and Mind Centre operates an early intervention youth service at Camperdown under contract with headspace. He is the Chief Scientific Advisor to, and a 3.2% equity shareholder in, Innowell Pty Ltd. Innowell was formed by the University of Sydney (45% equity) and PwC (Australia; 45% equity) to deliver the A$30 million (US$21.63 million) Australian Government-funded Project Synergy (2017–2020; a 3-year programme for the transformation of mental health services) and to lead the transformation of mental health services internationally through the use of innovative technologies. Importantly, Innowell has no role in the development, production or distribution of the Thrive by Five app. VL is a board member for Matana Foundation, a philanthropic organisation that provides funding to programmes for disadvantaged young people in Australia. She does not receive any financial benefit for this role., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Digital technologies are widely recognized for their equalizing effect, improving access to affordable health care regardless of gender, ethnicity, socioeconomic status, or geographic region. The Thrive by Five app is designed to promote positive interactions between children and their parents, extended family, and trusted members of the community to support socioemotional and cognitive development in the first 5 years of life and to strengthen connections to culture and community., Objective: This paper aims to describe the iterative co-design process that underpins the development and refinement of Thrive by Five's features, functions, and content. Minderoo Foundation commissioned this work as a quality improvement activity to support an engaging user experience and inform the development of culturally appropriate and relevant content for parents and caregivers in each country where the app is implemented., Methods: The app content, referred to as Collective Actions, comprises "The Why," that presents scientific principles that underpin socioemotional and cognitive development in early childhood. The scientific information is coupled with childrearing activities for parents, extended family, and members of the community to engage in with the children to support their healthy development and to promote positive connections between parents, families, and communities and these young children. Importantly, the initial content is designed and iteratively refined in collaboration with a subject matter expert group from each country (ie, alpha testing). This content is then configured into the app (either a beta version or localized version) for testing (ie, beta testing) by local parents and caregivers as well as experts who are invited to provide their feedback and suggestions for improvements in app content, features, and functions via a brief web-based survey and a series of co-design workshops. The quantitative survey data will be analyzed using descriptive statistics, whereas the analysis of qualitative data from the workshops will follow established thematic techniques., Results: To date, the co-design protocol has been completed with subject matter experts, parents, and caregivers from 9 countries, with the first results expected to be published by early 2023. The protocol will be implemented serially in the remaining 21 countries., Conclusions: Mobile technologies are the primary means of internet connection in many countries worldwide, which underscores the potential for mobile health programs to improve access to valuable, evidence-based, and previously unavailable parenting information. However, for maximum impact, it is critically important to ensure that mobile health programs are designed in collaboration with the target audience to support the alignment of content with parents' cultural values and traditions and its relevance to their needs and circumstances., International Registered Report Identifier (irrid): DERR1-10.2196/39225., (©Haley M LaMonica, Jacob J Crouse, Yun J C Song, Mafruha Alam, Mahalakshmi Ekambareshwar, Victoria Loblay, Adam Yoon, Grace Cha, Chloe Wilson, Madelaine Sweeney-Nash, Nathanael Foo, Melissa Teo, Mikael Perhirin, Jakelin Troy, Ian B Hickie. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 31.10.2022.)

Issue Addressed: One in four Australian children aged between the ages of two and four are affected by overweight. In New South Wales, the Communicating Healthy Beginnings Advice by Telephone (CHAT) trial delivered an intervention to pregnant women and women with infants via telephone calls and text messages. The focus of the intervention was on infant feeding and establishing healthy habits for infants by building the capacity of mothers. This study investigates trial collaborators' perspectives concerning the implementation of this intervention, to obtain insights that will support future translation and scale-up., Methods: This research was undertaken during the intervention phase of the trial. Twenty trial collaborators involved in the planning, implementation or delivery of the CHAT trial were invited to participate. Qualitative interviews were conducted with collaborators using open-ended questions based on Steckler and Linnan's process evaluation framework and the Consolidated Framework for Implementation Research. Inductive thematic analysis was employed to identify themes from the interview data., Results: Fourteen trial collaborators were interviewed. Collaborators included child and family health nurses (intervention providers), nurse managers with extensive child and family health nursing experience, a paediatrician, dietitians, health promotion experts, health service managers, health and nursing executives, program personnel (project coordinator, research fellow and evaluation officer) and university researchers. Following coding of qualitative data, themes were realised from the data as a result of active co-production on the part of the researcher. Five themes were identified: (a) context (organisational support, engagement and partnerships, communication and project leadership); (b) program receipt, benefit and reach; (c) program delivery (intervention providers' experience and skills, mode of intervention delivery, referral to other services, support and training for intervention providers); (d) implementation (program delivered as planned); (e) opportunities for scale-up. Collaborators perceived that the program was implemented and delivered as planned. This specific research addresses the success of the process of implementing and delivering interventions for infant feeding and establishing healthy habits for children by building the capacity of mothers. Collaborators attributed successful program implementation to contextual factors: strong support by the host organisation; good project leadership; clear communication; collaborative internal and external partnerships; intervention provision by experienced nurses. Remote delivery was convenient to program participants and participants were able to resolve other personal concerns in addition to direct immediate benefits. Because of their capacity to influence policy decisions, the absence of policymakers at project meetings was a shortcoming. Collaborative partnerships with health and research partners, understanding of contextual issues and consumer involvement could lead to program expansion. The program has the potential to be scaled up through integration with existing services and gradual expansion into other health districts prior to state-wide rollout., Conclusions: The CHAT trial delivered the Healthy Beginnings intervention which resulted in improvements in infant feeding, active play and sedentary behaviours. This evaluation demonstrated that the involvement of key stakeholders from early planning stages through to implementation of the program and the partnerships that evolved contributed to the successful implementation of the program. An unintended benefit to participants from this program was the social support that was provided. Intervention delivery via telephone and text messages enabled easy access to the program. Most importantly, the program has the potential to be scaled up through integration into existing services and gradual expansion prior to state-wide rollout. SO WHAT?: Strong internal and external partnerships, effective communication systems and integration with existing services create the context for potential translation and scaling up of the program to other health promotion settings., (© 2021 The Authors. Health Promotion Journal of Australia published by John Wiley & Sons Australia, Ltd on behalf of Australian Health Promotion Association.)

Background: Participant engagement with program interventions is vital to support intended behaviour changes and outcomes. The aim of this research was to investigate participant engagement with the Communicating Healthy Beginnings Advice by Telephone (CHAT) program, an early childhood obesity prevention program that included interventions for promoting healthy infant feeding practices and obesity-protective behaviours via telephone, and whether engagement with the telephone support program varied by participants' sociodemographic characteristics., Methods: This study used de-identified CHAT program data of participants who received the interventions via telephone. Data analysed included 1) participant engagement in telephone support from late pregnancy to 12 months of child's age, 2) demographic characteristics collected at late pregnancy and 3) intervention providers' observations and notes (qualitative data) for 10 participants from each engagement group (low, medium, high) to explore issues discussed during telephone support., Results: Call completion rate by participants was above sixty percent for all six stages of the telephone support program with more than half of the participants (57%) demonstrating high level of engagement. We found that participants' country of birth, employment status and annual household income were predictors of engagement with the telephone support provided in the CHAT program. The odds of participants' engagement with the telephone support program were 1.68 times higher for Australian born (95% CI 1.07 - 2.62), 1.63 times higher for participants who were employed (95% CI 1.01 - 2.66) and 1.63 times higher for participants with annual household income ≥AUD$80,000 (95% CI 1.02 - 2.60)., Conclusions: Participant engagement with the program interventions was good. Participants' engagement with the telephone support program was significantly associated with certain socio-demographic characteristics. Australian born participants, and participants associated with higher household income and employment engaged significantly more with the telephone support provided in the CHAT program. Additionally, the program engaged more participants older than 30 years of age and those who spoke English at home. The program provided unintended personal benefits to some participants with high engagement level due to their various psychosocial needs such as domestic violence, mental health and sleep related issues. Although not an intended benefit of the intervention, psychosocial needs of participants were met which was a likely factor for mothers' engagement with the program. This is an important factor that needs to be considered while implementing future programs or scale up of this program., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Ekambareshwar, Xu, Rissel, Baur, Taki, Mihrshahi and Wen.)

Childhood overweight and obesity is a worldwide public health issue. Our objective was to describe planned, ongoing and completed randomized controlled trials (RCTs) designed for the prevention of obesity in early childhood. Two databases (World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov) were searched to identify RCTs with the primary aim of preventing childhood obesity and at least one outcome related to child weight. Interventions needed to start in the first two years of childhood or earlier, continue for at least 6 months postnatally, include a component related to lifestyle or behaviours, and have a follow up time of at least 2 years. We identified 29 unique RCTs, implemented since 2008, with most being undertaken in high income countries. Interventions ranged from advice on diet, activity, sleep, emotion regulation, and parenting education through to individual home visits, clinic-based consultations, or group education sessions. Eleven trials published data on child weight-related outcomes to date, though most were not sufficiently powered to detect significant effects. Many trials detected improvements in practices such as breastfeeding, screen time, and physical activity in the intervention groups compared to the control groups. Further follow-up of ongoing trials is needed to assess longer-term effects.

Background: Increasingly, public health interventions are delivered via telephone and/or text messages. Recent systematic reviews of early childhood obesity prevention interventions have not adequately reported on the way interventions are delivered and the experiences/perceptions of stakeholders. We aimed to summarise the literature in early childhood obesity prevention interventions delivered via telephone or text messages for evidence of application of process evaluation primarily to evaluate stakeholders' acceptability of interventions., Methods: A systematic search of major electronic databases was carried out using the Population, Intervention, Comparison, Outcomes framework. Studies were included if interventions were delivered via telephone/text messages; aimed at changing caregivers' behaviours to prevent early childhood obesity; with one or more outcomes related to early obesity risk factors such as breastfeeding, solid feeding, tummy time, sleep and settling, physical activity and screen time; published from inception to May 2020. All eligible studies were independently assessed by two reviewers using the Cochrane Collaboration tool for assessing risk of bias. Qualitative studies were assessed using the Consolidated Criteria for Reporting Qualitative Research and Standards for Reporting Qualitative Research tools., Results: Twenty-four studies were eligible, and the overall risk of bias was low. Eight studies (33%) had evidence of process evaluation that examined participants' perceptions of interventions. Participants appreciated the convenience of receiving interventions via telephone or text messages. 63% of all studies in this review showed improvement in one or more behaviours related to childhood obesity prevention. Participants were likely to modify behaviours if they received information from a credible source such as from health professionals., Conclusion: There is limited reporting of stakeholders' experiences in early obesity prevention studies delivered by telephone or text messages. Only one-third of studies examined participants' acceptability and the potential for delivery of childhood obesity prevention interventions conveniently using this mode of delivery. Interventions delivered remotely via telephone or text messages have the potential to reach equal or a greater number of participants than those delivered via face-to-face methods. Future research should build in process evaluation alongside effectiveness measurements to provide important insight into intervention reach, acceptability and to inform scale up., Trial Registration: PROSPERO registration: CRD42019108658.

Background: Childhood obesity is a global problem. Early obesity prevention interventions are complex and differ in effectiveness. Novel frameworks, taxonomies and experience from the Early Prevention of Obesity in CHildren (EPOCH) trials were applied to unpack interventions., Objectives: Deconstruct interventions into their components (target behaviours, delivery features and behaviour change techniques [BCTs]). Identify lessons learned and future recommendations for intervention planning, delivery, evaluation and implementation., Methods: This multi-methods study deconstructed the four EPOCH interventions into target behaviours, delivery features and BCTs from unpublished and published materials using systematic frameworks. Additionally, semi-structured interviews were conducted with intervention facilitators and principal investigators., Results: Each trial targeted between 10 and 14 obesity-related behaviours. Key variations in delivery features related to intensity, delivery mode and tailoring. BCTs consistently used across trials included goal-setting, social support, shaping knowledge, role-modelling and credible source. Recommendations from interview analyses include the importance of stakeholder collaboration and consideration of implementation throughout the study process., Conclusions: The combination of frameworks, methodologies and interviews used in this study is a major step towards understanding complex early obesity prevention interventions. Future work will link systematic intervention deconstruction with quantitative models to identify which intervention components are most effective and for whom., (© 2020 World Obesity Federation.)

A 3-arm randomised controlled trial implemented in 2017, recruited participants from four Local Health Districts (LHDs) in New South Wales (NSW) to test an early obesity prevention program delivered via telephone calls (telephone) or text messages (SMS). This sub-study explored participants' experience and satisfaction with the program. A multimethod design was used. Quantitative satisfaction questions were completed by participants when their child was six-months old. A purposive sample of participants with varying satisfaction levels was invited for in-depth qualitative interviews. Data were analysed using Excel (quantitative) and inductive thematic analysis (qualitative). Of the 1155 participants recruited: 947 (293 telephone; 338 SMS; 316 control) completed the six-month survey; 34 (14 telephone; 13 SMS; 7 control) were interviewed. Participants' overall program satisfaction was 100% (telephone) and 85% (SMS). Participants' qualitative responses demonstrated appreciation of: personalised stage-based information; opportunity to communicate with health professionals (telephone); linked Healthy Beginnings booklets and SMS mostly as nudges (SMS). There is a clear need for stage-based information, and supplemented modes of delivery i.e., text messages along with telephone calls; with text messages solely seen as nudges or reminders. However, individual preferences vary according to information needs at any given time, time constraints on new mothers and hence, multiple modes of information provision are recommended in order to reach a wider population and for better engagement. Choice and flexibility in mode of delivery has the potential to provide equitable access to information, empowering women with infants to practice recommended health behaviours for infant obesity prevention., Competing Interests: Researcher Description: All researchers of this research study were also part of a larger study evaluating the effectiveness of the CHAT RCT. Authors M.E., S.T., S.M., L.A.B., C.R., L.M.W. are public health researchers at various professional stages from early to senior career, experienced with evaluating early childhood obesity prevention interventions in populations. The researchers bring to this study expertise in quantitative and qualitative research skills, as well as diverse multi-disciplinary backgrounds in medicine, dietetics and science. To ensure the research team remained impartial, L.A.B. as the director of EPOCH CRE was not involved in the data collection or analysis. This study was conducted as part of M.E.’s doctoral research of process evaluation of the CHAT RCT. Detailed quality assessment against CoreQ in Appendix A.

Background: Recruitment of pregnant women into trials is a challenge exacerbated by a number of factors, including strict eligibility criteria. There has been little in-depth examination of the recruitment process to trials involving pregnant women. This paper presents the findings of a study conducted to identify facilitators and challenges in recruiting pregnant women to the Communicating Healthy Beginnings Advice by Telephone (CHAT) randomised controlled trial, which aims to reduce the prevalence of infant and childhood obesity., Methods: Data were collected from (1) administration of a short questionnaire to women at the time of recruitment exploring women's reasons for consent and non-consent; (2) interviews with recruiters to capture recruiters' experiences of the recruitment process; and (3) analysis of field notes taken by recruiters on the number of women approached/recruited and reasons as to why they did not consent to participate. Data obtained were triangulated to gain insights into the process of recruiting pregnant women., Results: A total of 1155 pregnant women (mean gestational age 31.5 weeks) were enrolled over 5 months. The main reasons for women consenting to participate in the study were convenience in programme delivery mode via telephone calls or text messages, altruism and because the programme was free of charge. The main reasons for women not consenting were lack of interest, language challenges/difficulty speaking English and some felt they did not need information and support due to prior experience as a mother. Facilitators included organisational support, rapport with recruiters and some women with no other children who needed advice. Despite the challenges, the mode of delivery of intervention via telephone calls or text messages, the minimal effort required of women to participate, organisational support from the lead site and recruiters' knowledge of and commitment towards the trial contributed towards successful recruitment., Conclusion: Despite some challenges in recruiting pregnant women to an infant obesity prevention programme, some of the facilitators in recruitment included mode of delivery of the intervention programme via telephone calls or text messages, the minimal effort required for women to participate, organisational support from the lead site, and recruiters' knowledge of and commitment towards the trial., Trial Registration: The CHAT RCT is registered with the Australian Clinical Trial Registry ( ACTRN12616001470482p ); Ethics Review Committee of Sydney Local Health District (Protocol No. X16-0360 & LNR/16/RPAH/495).