SEARCHRCTobstetrics and gynecology, endocrinology

RCT·obstetrics and gynecology, endocrinology, public health, clinical trial, nutrition·PMC10546269

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

JMIR Research Protocols · 14 authors, 12 centres

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TL;DR

The study aims to evaluate both the effectiveness of the intervention on postpartum weight and the feasibility of its implementation in routine services across four countries.

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The study will recruit 800 women in early pregnancy to a randomized controlled trial evaluating an 18-month mHealth coaching intervention (B2B&Me) designed to sit alongside usual perinatal care. The study aims to address the gap between evidence for behavior change interventions and their routine implementation. Limitations include potential recruitment bias inherent to RCTs and variation across participating countries. As this is a protocol, no effectiveness results are available; the study is ongoing with data collection expected to complete in 2024. The findings are anticipated to inform the potential scale-up of such interventions.

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RCT

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obstetrics and gynecology

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ORIGINAL PAPER

PMC10546269

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

JMIR Research Protocols

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ABSTRACT

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 Keywords: hybrid type 2 effectiveness-implementation, gestational diabetes, obesity, mHealth, mobile health, health behavior change, pregnancy, postpartum, weight management, health coaching, maternal health

CITATION EXPORT

Sharleen L O'Reilly, Rachel Laws, Helle Terkildsen Maindal et al.. 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. JMIR Research Protocols. (2023). https://doi.org/10.2196/51431

AUTHORS

14 · 12 CENTRES

Sharleen L O'Reilly, Rachel Laws, Helle Terkildsen Maindal, Helena Teede, Cheryce Harrison, Fionnuala M McAuliffe, Aisling Geraghty, Cristina Campoy, Mercedes G Bermúdez, Laura Pirhonen, Christy Burden, Anna Davies, Ditte Hjorth Laursen, Timothy Skinner

1School of Agriculture and Food Science, University College Dublin, Dublin, Ireland
2University College Dublin Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland
3School of Exercise and Nutrition Science, Deakin University, Burwood, Australia
4Department of Public Health, Aarhus University, Aarhus, Denmark
5Monash Centre for Health Research and Implementation, Monash University, Melbourne, Australia
6Department of Paediatrics, School of Medicine, EURISTIKOS Excellence Centre for Paediatric Research, University of Granada, Granada, Spain
7Instituto de Investigación Biosanitaria, Health Sciences Technological Park, Granada, Spain
8Institute of Psychology, University of Copenhagen, Copenhagen, Denmark
9Bristol Medical School, University of Bristol, Bristol, United Kingdom
10Liva Healthcare, Copenhagen, Denmark
11Australian Centre for Behavioural Research in Diabetes, Deakin University, Geelong, Australia
12See Acknowledgements