A Complex mHealth Coaching Intervention to Prevent Overweight, Obesity, and Diabetes in High-Risk Women in Antenatal Care: Protocol for a Hybrid Type 2 Effectiveness-Implementation Study

Abstract

Background Women with overweight and obesity are at higher risk of developing complications in pregnancy such as gestational diabetes and longer-term chronic conditions. Research concerning health behavior change interventions during pregnancy and postpartum shows promising effects, but implementation into routine services is sparsely investigated. Most interventions focus on the antenatal or postpartum life stages, failing to meet the needs of women. IMPACT DIABETES Bump2Baby is a multicenter project across 4 high-income countries developed to test the implementation of an antenatal and postpartum evidence-based mobile health (mHealth) coaching intervention called Bump2Baby and Me (B2B&Me) designed to sit alongside usual care in the perinatal period. Objective We aim to explore the feasibility and implementation of the B2B&Me intervention and investigate the effectiveness of this intervention in women at risk of gestational diabetes. Methods IMPACT DIABETES Bump2Baby is a hybrid type 2 effectiveness-implementation study, which integrates an evidence-based mHealth coaching app that includes personalized health behavior change coaching provided by health care professionals alongside antenatal care from the first antenatal visit to 12 months postpartum. The mHealth app offers the possibility of synchronous calls, asynchronous contact (including coach-participant text and video messaging exchanges tailored to the participant’s needs), and ongoing access to an extensive library of bespoke intervention materials. Participants will interact asynchronously with their health coach throughout the intervention via the app. This randomized controlled trial across 4 clinical sites within Ireland, the United Kingdom, Spain, and Australia will recruit 800 women in early pregnancy to evaluate the effectiveness on postpartum weight. The Exploration, Preparation, Implementation, and Sustainment implementation framework is the theoretical underpinning of the study. The implementation evaluation will be assessed at the individual, hospital staff, and broader community levels using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources for the RE-AIM evaluation will include app and platform analytics, screening and training records, participant medical records, key informant interviews, participant and partner exit interviews, cost data, study questionnaires, staff surveys, and blood sample analyses. Results The study was approved and registered with the Australian New Zealand Clinical Trials Registry on November 19, 2020. Recruitment commenced on February 9, 2021, and data collection is ongoing. Publication of the results is expected in 2024. Conclusions This is the first hybrid effectiveness-implementation study of an 18-month mHealth coaching intervention in at-risk women that we are aware of. As research aims to move toward real-world implementable solutions, it is critical that hybrid studies are conducted. The data from this large multicenter study will be useful in planning the potential implementation and scale-up of evidence-based perinatal health behavior change interventions. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12620001240932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380020&isReview=true International Registered Report Identifier (IRRID) DERR1-10.2196/51431

Protocol for cost-effectiveness analysis of a randomised trial of mHealth coaching (Bump2Baby and Me) compared with usual care for healthy gestational weight gain and postnatal outcomes in at-risk women and their offspring in the UK, Australia, Ireland and Spain

“…The control group receives usual care according to the maternity care at each site. 29 In addition, the control group participants will be provided with links to standard information sources on gestational diabetes and lifestyle. Both intervention and usual care will receive electronic newsletters updating them on the study’s progress.…”

Exploring the Intersection of Empathy and Behavior Change Techniques in Telehealth Coaching Messages: A Survey Study

“…To assess HC responses, we developed two different surveys to be completed in relation to 10 patient messages from the Bump2baby trial [34]. The rst round focused on the most appropriate techniques (BCTs, MITs, and SDTTs) that HCs would use in a written response according to their coaching background.…”

“…The Bump2Baby and Me trial [34], where the authors are authorized researchers, is the source of the dataset we used to obtain the 10 throughout the study's duration to ensure data anonymity. We administered the survey using SurveyXact® (Rambøll Group A/S, Copenhagen), and the platform automatically anonymised HCs' replies upon survey completion.…”

Implementing weight management during and after pregnancy to reduce diabetes and CVD risk in maternal and child populations

“…It will expand the health coaching provided during the first postpartum year to include healthy infant feeding and active play alongside healthy family meals. The study is underpinned by the EPIS framework and will use NPT to achieve better understanding of the factors that influenced normalisation of the intervention in both the healthcare setting and in the women (119) . The primary outcome of the randomised controlled trial is maternal weight at 12 months.…”

“…The primary outcome of the randomised controlled trial is maternal weight at 12 months. The RE-AIM evaluation framework will be used to explore implementation and fidelity aspects as secondary outcomes (119) .…”