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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity College Dublin

About this trial

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.

Eligibility criteria

Qualifiers

Pregnant women attending their first/early antenatal appointments at participating sites

Gestation less than 24 weeks at enrolment

Age 18 years or older

Ability to provide informed consent

Disqualifiers

24 weeks gestation or higher

Multiple pregnancy (twins, triplets, etc.)

Participation in another health behaviour change intervention study during pregnancy

Inability to understand the language of the intervention (English in Ireland, Spanish in Spain, Norwegian in Norway, Polish in Poland)

Trial design

Treatments tested in this trial

  • Life Style Intervention

Treatment groups

3,600 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University College Dublin

Lead sponsor

National Maternity Hospital, Ireland

Collaborator

Aarhus University Hospital

Collaborator

Liva Healthcare A/S

Collaborator

Western Norway University of Applied Sciences

Collaborator

University of Agder

Collaborator

Pomeranian Medical University Szczecin

Collaborator

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Collaborator

Deakin University

Collaborator