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

Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children

Sharleen L O'Reilly  1   2 , Christy Burden  3 , Cristina Campoy  4 , Fionnuala M McAuliffe  2 , Helena Teede  5 , Jesper Andresen  6 , Karen J Campbell  7 , Aisling A Geraghty  1   2 , Cheryce L Harrison  5 , Rachel Laws  7 , Jane E Norman  3 , Helle T Maindal  8 , Karsten Vrangbæk  9 , Ricardo Segurado  10 , Vincent L Versace  11 , Timothy C Skinner  12   13 ; IMPACT DIABETES B2B Collaboration Group
Affiliations

Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children

Sharleen L O'Reilly et al. Trials. .

Abstract

Background: Gestational diabetes (GDM) impacts 8-18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM.

Methods: Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks' gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early 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 maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received.

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

Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12620001240932 . Registered on 19 November 2020.

Keywords: Foetal programming; Gestational diabetes; Health coaching; Implementation; Maternal health; Obesity; Postpartum; Pregnancy; Weight management; mHealth.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart with an overview of the time points and data collected in the Bump2Baby and Me study
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) timeline providing information about participant enrolment, intervention, and outcomes evaluated during the trial according to SPIRIT recommendations
Fig. 3
Fig. 3
Summary of the Bump2Baby and Me intervention components and frequency of each in the app
See this image and copyright information in PMC

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