Implementation and Evaluation of Bump2Baby and Me+ Programme for Gestational Diabetes Mellitus in Routine Maternity Care Setting.

Gestational diabetes mellitus (GDM) affects approximately 1 in 7 pregnancies globally and is associated with significant short and long-term health consequences for both mothers and infants. While lifestyle interventions during pregnancy can effectively reduce GDM risk and its complications, there is limited guidance on how to translate this evidence into routine antenatal and postpartum care. This project looks to address this gap by exploring the effectiveness of the B2B\&Me+ programme within regular maternity services across four European countries and how best to implement it. Women identified as being at higher risk of developing GDM using a GDM screening tool will receive access to the smartphone application that connects them with their health coach, who will provide personalised support about healthy eating, physical activity, mental wellbeing, and infant care from early pregnancy until 9 months after birth. The participants will be randomised initially to a specific referral pathway for the intervention.

NCT Number	NCT07189221
Lead Sponsor	University College Dublin Collaborators: National Maternity Hospital, Ireland, Aarhus University Hospital, Liva Healthcare A/S, Western Norway University of Applied Sciences, University of Agder, Pomeranian Medical University Szczecin, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental, Deakin University
Conditions	Gestational Diabetes Mellitus (GDM)
Enrollment	3,600 participants
Start Date	2025-12-01
Primary Completion	2027-12-01 (estimated)
Study Completion	2028-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-23