Bump2Baby & Me+ (B2B&Me+): Protocol for a multi-country, European hybrid type 3 implementation-effectiveness study to reduce the incidence of gestational diabetes mellitus and improve maternal and child health
Abstract
Background: Gestational diabetes mellitus (GDM) affects 1-in-7 pregnancies globally and is associated with significant short- and long-term health consequences. Although health behaviour change interventions can effectively reduce these risks, a significant implementation gap exists in translating this evidence into routine practice. Bump2Baby and Me (B2B&Me) was a mobile health (mHealth) coaching intervention provided to women at-risk of GDM from early pregnancy through to 1-year postpartum. B2B&Me Plus (B2B&Me+) aims to refine, implement and evaluate the implementation of this personalised intervention across 4 countries (Ireland, Spain, Poland and Norway) with differing health systems and population profiles.
Methods: This study employs a hybrid type 3 implementation-effectiveness design using a non-randomised ABA block approach within a longitudinal cohort. Participants will be screened using the Monash machine learning GDM screening tool (MMLGDST). During the intervention (Block B), women at risk of developing GDM will be offered access to a smartphone-based coaching application featuring 1:1 synchronous sessions, asynchronous text and video messaging along with a Bluetooth-enabled weighing scale for self-monitoring. Support continues from early pregnancy through to nine months postpartum. The study's primary objective is to evaluate reach, adoption, implementation and maintenance of the B2B&Me+ intervention programme when delivered within routine maternity care.…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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