Status:
NOT_YET_RECRUITING
Implementation and Evaluation of Bump2Baby and Me+ Programme for Gestational Diabetes Mellitus in Routine Maternity Care Setting.
Lead Sponsor:
University College Dublin
Collaborating Sponsors:
National Maternity Hospital, Ireland
Aarhus University Hospital
Conditions:
Gestational Diabetes Mellitus (GDM)
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 lif...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- Additional for the intervention group (Block B):
- Identified as higher risk for GDM using the MMLGDST
- Ownership of a smartphone compatible with the B2B\&Me+ app
Exclusion
- 24 weeks gestation or higher
- Multiple pregnancy (twins, triplets, etc.)
- Additional for the intervention group (Block B):
- 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)
- Severe mental illness, drug or alcohol abuse that would impair ability to participate
- Cancer (not in remission)
- Myocardial infarction in the last three months
- Pre-existing diabetes (Type 1 or Type 2), or early GDM.
- Not owning a smartphone capable of hosting the intervention app
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
3600 Patients enrolled
Trial Details
Trial ID
NCT07189221
Start Date
December 1 2025
End Date
May 31 2028
Last Update
September 23 2025
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