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
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