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.
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
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)
Sequential
Life Style Intervention
BehavioralThe 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
Penetration and participation rates in early pregnancy GDM screening and intervention
The primary analysis will compare penetration across the different blocks (A vs B), participation rates and different referral methods within Block B. This will be analysed using chi-square tests for categorical data and t-tests or ANOVA for continuous data.
Maternal Weight and BMI at baby's birth
Maternal weight (kg) and Body Mass Index (gestational weight gain)
GDM incidence at baby's birth.
GDM incidence rate.
Adverse Birth Outcomes
Rates of adverse birth outcomes (pre-eclampsia, preterm birth, birth weight ≥4000g, birth trauma, neonatal respiratory distress, phototherapy, stillbirth/neonatal death, NICU admission or shoulder dystocia, caesarean section/interventions)
Breastfeeding Initiation.
Breastfeeding initiation rates and on discharge
Click on the lead sponsor to view all of their trials.
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
This trial is not recruiting at the moment. You can still explore other options:
