Bump2 baby and me: protocol for a randomised control trial of mhealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their offspring

Introduction: The prevalence of obesity in pregnancy has been increasing in high‐income countries. This increases the risk of pregnancy complications, such as gestational diabetes (GDM), and adverse outcomes including large for gestational age births, and increased weight retention postpartum for the mother. GDM affects up to 18% of pregnancies and also increases both the woman's and child's risk of developing non‐communicable diseases such as type 2 diabetes. IMPACT DIABETES B2B will demonstrate the real‐world implementation of an evidence‐based, effective system of care for prevention of diabetes, overweight, and obesity when delivered 'at scale' across antenatal settings. Bump2Baby and Me is the multicentre randomised controlled trial central to the project that aims to investigate a mHealth coaching program for women who are at high risk of developing GDM. Methods: 800 women will be recruited in early pregnancy from 4 clinical sites within Ireland, UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled at approximately 12 weeks' gestation and randomised on a 1:1 basis into the intervention or usual care arm. The intervention group will receive mHealth coaching via a smartphone application, which will use a mixture of synchronous and asynchronous video and text messaging and allow for personalised support and goal setting with a health coach. The usual care arm of the study is standard information provision as part of usual antenatal care. Results: The Bump2Baby and Me study will assess the effectiveness and cost‐efficiency of a low‐cost health coaching lifestyle behaviour change app on weight and health outcomes for both mother and child through pregnancy and the first year following birth. The primary outcome will be change in maternal weight at 12 months postpartum. Secondary maternal and infant health outcomes will include development of GDM, weight management in pregnancy, diet, physical activity, sleep, infant health and growth patterns. Conclusion: There is a large research translation gap around delivering implementable interventions with adequate population penetration and participation, and this project aims to address this through implementation into routine service delivery. It is anticipated that this study will contribute to early prevention of maternal and child diabetes, overweight, obesity, and other non‐communicable diseases.