Implementation Study Design
Study Type: Hybrid type 3 implementation-effectiveness trial
Design: Non-randomised, ABA intervention design within longitudinal cohort
Primary Endpoint: Penetration and participation in early pregnancy gestational diabetes risk screening and Bump2Baby and Me Plus mHealth coaching.
Study Sites and Participants
Four Implementation Sites:
- Dublin, Ireland (National Maternity Hospital)
- Kristiansand, Norway (Sørlandet Hospital Trust)
- Granada, Spain (University Hospital San Cecilio)
- Szczecin, Poland (Pomeranian Medical University)
Target Participants: 3,600 participants across all sites (300 per site per block)
The ABA Design
Block A (3 months): Usual care data collection Block B (3 months): B2B&Me+ intervention with mHealth coaching offered to all women who screen as being at risk of developing gestational diabetes Block A (3 months): Usual care data collection
Screening and Referral
Monash Machine Learning Gestational Diabetes Screening Tool (MMLGDST)
- Machine learning used to improve the original screening tool’s algorithm and predictive performance
- Categorises women into higher or lower risk of developing gestational diabetes and who would benefit from a lifestyle intervention to reduce that risk
- Women screened in the higher risk category will be eligible for the B2B&Me+ mHealth coaching
Referral Methods
The trial will explore whether different referral methods change the number of women participating in the mHealth coaching. To test this, we will randomise the following methods:
- Point-of-care active support only
- Leaflet only
- Point-of-care with phone follow-up
- Leaflet with phone follow-up
Outcome Measurements
Primary Outcome:
- Penetration and participation rates
Secondary Outcomes:
- Gestational diabetes development reduction
- Maternal BMI reduction at 9 months postpartum
- Gestational weight gain
- Adverse pregnancy outcomes
- Healthcare system costs
- Infant growth and development
- Implementation measures (reach, adoption, maintenance)
The B2B&Me+ Support Programme
What Each Woman in Block B at Risk of Gestational diabetes will Receive:
- Personalised mHealth coaching app
- Health coach support from a trained health professional (not AI)
- Evidence-based guidance on healthy eating, physical activity and mental health
- Support from early pregnancy through nine months postpartum
- Bluetooth scales for weight monitoring
Content Areas Covered
- Healthy eating during pregnancy and postpartum
- Physical activity and exercise
- Weight management strategies after birth
- Breastfeeding and infant feeding support
- Support for mothers and babies on sleep
- Active play and development for babies
- Stress management