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

Summary

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.

Conditions

• Gestational Diabetes Mellitus (GDM)

Interventions

BEHAVIORAL

Life Style Intervention

The intervention consists of seven related components: I. A Bluetooth-enabled weighing scale that syncs with the app to facilitate self-monitoring of weight. II. Synchronous coaching sessions conducted on a 1:1 basis between the mHealth coach and participants. There will be 2 synchronous sessions, the first at enrolment and the second between 6-8 weeks postpartum. These sessions typically last 45-50 minutes in length with a follow-up summary video message of the goals discussed and, at the beginning of the mother's journey, the establishing of a change agreement. This is mediated through the live-video feature in the B2B\&Me+ mHealth coaching app, but the length and thus number of these sessions is determined by the woman. If the woman is diagnosed with GDM, there will be an opportunity for a third 15-minute synchronous coaching session to review and adjust any lifestyle goals to align with the individual's diabetes management plan. III. Asynchronous mHealth coaching that uses a combi

Sponsors & Collaborators

• National Maternity Hospital, Ireland

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Liva Healthcare A/S

  collaborator UNKNOWN

• Western Norway University of Applied Sciences

  collaborator OTHER

• University of Agder

  collaborator OTHER

• Pomeranian Medical University Szczecin

  collaborator OTHER

• Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

  collaborator OTHER

• Deakin University

  collaborator OTHER

• University College Dublin

  lead OTHER

Principal Investigators

• Sharleen O'Reilly · University College Dublin

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2027-12-01

Completion

2028-05-31