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. Building on the successful Horizon2020-funded Bump2Baby and Me trial, this implementation project seeks to address this gap by testing the real-world effectiveness of the B2B&Me+ programme within regular maternity services across four European countries.
This is a hybrid type 3 implementation-effectiveness study using a non-randomised, ABA intervention design nested within a longitudinal cohort. As a type 3 hybrid, focus is primarily on implementation outcomes while also collecting effectiveness outcomes as they relate to uptake or fidelity of the intervention. The study will compare the delivery of the Monash machine learning GDM screening tool (MMLGDST)12 and mHealth coaching referral during a 3-month intervention block (B) with two 3-month blocks of usual care, before and after the intervention (A blocks).
Block A (Usual care phases): The research staff will briefly explain the data collection aspect of the study and provide an information leaflet. Women will be informed that the study involves collecting anonymised data from their medical records for research purposes, with no additional procedures or interventions beyond their standard care.
Within the intervention block (B), different referral methods will be tested every 2 weeks:
- Point-of-care (POC) active referral only
- POC with follow-up phone call
- Leaflet provided at time of consent with follow-up phone call
- Leaflet referral only This real-world implementation design will allow us to evaluate not only the clinical effectiveness of the intervention but also the implementation processes, contextual factors, and sustainability of the programme within routine care.
The intervention (B2B&Me+ programme) involved is a lifestyle intervention comprised of the following 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 at enrolment and 6-8 weeks postpartum.
III. Asynchronous mHealth coaching that uses a combination of text and video messaging exchanges between the mHealth coach and participant.
IV. Automated push notifications are sent out to participants. V. Participants will receive personalised educational content from their mHealth coach during the asynchronous coaching sessions.
VI. Participants will receive automated push notifications referring to additional content available in the B2B&Me+ app.
VII. Participants will also have access to a virtual social network, through the mHealth coaching app, with other women participating in the study.
