Bump2Baby and Me: Protocol for a Randomized Trial of mHealth Coaching for Healthy Gestational Weight Gain and Better Postnatal Outcomes in High-Risk Women and Their Children


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Tests. Dec 28, 2021; 22 (1): 963. doi: 10.1186 / s13063-021-05892-4.

ABSTRACT

BACKGROUND: Gestational diabetes (GD) affects 8-18% of pregnancies and dramatically increases the risk for both mother and child of developing non-communicable diseases such as type 2 diabetes and obesity. While lifestyle interventions during pregnancy and postpartum reduce this risk, a research translation gap remains around the implementation of interventions that are achievable with adequate population penetration and participation. Impact Diabetes Bump2Baby is an evidence-based healthcare system implementation project for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomized controlled trial investigating the effectiveness of an mHealth coaching program during pregnancy and postpartum for women at high risk of developing GDM.

METHODS: Eight hundred women will be recruited during early pregnancy at 4 clinical sites in Ireland, UK, Spain and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be recruited from 12 to 24 weeks gestation and randomized on a 1: 1 basis to the intervention or control arm. In addition to usual care, the intervention involves mHealth coaching via a smartphone app, which uses a combination of synchronous and asynchronous video and text messaging, and allows personalized support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from the start of pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg / m2 at 12 months postpartum. Secondary outcomes for mother and infant include development of GDM, gestational weight gain, pregnancy outcomes, improved diet, physical activity, sleep, newborn weight, and patterns. infant growth. The 5-year project is funded by the European Commission Horizon 2020 and the Australian National Council for Health and Medical Research. Ethics approval has been received.

DISCUSSION: Previous interventions did not go beyond tightly controlled efficacy trials in routine service delivery. This project aims to provide sustainable, evidence-based support that could be integrated into usual care for women during pregnancy and postpartum. This study will provide evidence to inform the early prevention of noncommunicable diseases like obesity and diabetes in mothers and the next generation.

TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12620001240932. Recorded November 19, 2020.

PMID:34963483 | PMC:PMC8713543 | DO I:10.1186 / s13063-021-05892-4


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