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 O'Reilly, Sharleen L. Campoy Folgoso, Cristina García Bermúdez, María Mercedes IMPACT DIABETES B2B Consortium Hybrid type 2 effectiveness-implementation Gestational diabetes Obesity MHealth Mobile health Health behavior change Pregnancy Postpartum Weight management Health coaching Maternal health This project is funded by the European Union Commission Horizon 2020 grant entitled "Implementation Action to Prevent Diabetes from Bump 2 Baby (IMPACT DIABETES B2B) " under grant agreement 847984, with collaborative National Health and Medical Research Council, Australia co -funding under grant number APP1194234. The project is sponsored by University College Dublin. The funders and the sponsor have no role in the design of the study, the collection, analysis, and interpretation of data, or in the writing of the manuscript or decision to publish. The contributors associated with IMPACT DIABETES B2B Consortium1 are as follows: Janine Wirth, School of Agriculture and Food Science, University College Dublin, Dublin, Ireland; Mary Codd, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland; Ricardo Segurado, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland; Jacqueline Boyle, Eastern Health Clinical School, Monash University, Melbourne, Australia; Georgia Soldartis, Monash Health, Melbourne, Australia; Alberto Puertas, School of Medicine, University of Granada, Granada, Spain; Francisca S Molina, School of Medicine, University of Granada, Granada, Spain; Maria Garcia-Ricobaraza, School of Medicine, University of Granada, Granada, Spain; Nanna Husted Jensen, Department of Public Health, Aarhus University, Aarhus, Denmarkv; Elena Rey Velasco, Liva Healthcare, Copenhagen, Denmark. 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. 2023-11-28T10:50:47Z 2023-11-28T10:50:47Z 2023-09-18 journal article O'Reilly SL, Laws R, Maindal HT, Teede H, Harrison C, McAuliffe FM, Geraghty A, Campoy C, Bermúdez MG, Pirhonen L, Burden C, Davies A, Laursen DH, Skinner T, IMPACT DIABETES B2B Consortium 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 Res Protoc 2023;12:e51431. [doi: 10.2196/51431] https://hdl.handle.net/10481/85893 10.2196/51431 eng info:eu-repo/grantAgreement/EC/H2020/847984 http://creativecommons.org/licenses/by/4.0/ open access Atribución 4.0 Internacional JMIR Publications