Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 31, 2023
Date Accepted: Aug 16, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Implementing a mHealth coaching intervention to prevent overweight, obesity and diabetes in high-risk women in perinatal care: an implementation protocol
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 behaviour change interventions during pregnancy and postpartum show 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 Bump 2 Baby (B2B) is a multi-centre project across four 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 the B2B&Me intervention in women at risk of gestational diabetes.
Methods:
IDB2B is a hybrid type two effectiveness-implementation study, which integrates an evidence-based mHealth coaching app that includes personalised health coaching provided by healthcare professionals alongside antenatal care to twelve months postpartum. This randomised controlled trial across four clinical sites within Ireland, UK, Spain, and Australia will recruit 800 women in early pregnancy to evaluate effectiveness on postpartum weight. The Exploration, Preparation, Implementation, Sustainment (EPIS) implementation framework is the theoretical underpinning of the study. The implementation evaluation will be assessed at individual, hospital staff, and broader community levels using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.
Results:
The study was approved and registered with the Australian New Zealand Clinical Trials Registry on 19th November 2020. Recruitment commenced on 9th February 2021 and data collection is ongoing. Publication of the results are 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 towards real-world implementable solutions, it is critical that hybrid studies are conducted. The data from this large multi-centre study will be useful in planning the implementation and scale-up of evidence-based perinatal health behaviour change interventions. Clinical Trial: Australian New Zealand Clinical Trials Registry ACTRN12620001240932. Registered on 19th November 2020.
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