Work

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

Year: 2026

Type: article

Abstract: 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. Implementation success will be assessed using the RE-AIM framework, while secondary outcomes will assess intervention effectiveness. The study will examine population-level uptake at each site, evaluate the benefits and costs of implementation across varying contexts, and analyse how four different referral methods, randomised at the site level, affect uptake. In addition, a European implementation toolkit will be developed to provide health services with scalable strategies to bridge the evidence-to-practice gap. Discussion This study will contribute to a growing literature on the implementation of a successfully trialled mHealth intervention in a real-world context. Understanding variation in both intervention and implementation success within a routine maternity care context across diverse settings will inform the development of an implementation toolkit to support health services in reducing the incidence of GDM and improving maternal and child health outcomes. This study was registered with ClinicalTrials.gov ( NCT07189221 ) on 28 August 2025 ( https://clinicaltrials.gov/study/NCT07189221?cond=diabetes ) Contributions to the literature B2B&Me+ is the first multi-site European study testing how a mobile health coaching programme for women at-risk of gestational diabetes can be delivered within routine maternity care across four countries. The study tests four strategies for inviting women to join the programme, with the intent to identify which strategy most effectively reaches and engages them in practice. Using established implementation science frameworks, B2B&Me+ examines what drives or hinders delivery across four diverse European health systems, generating evidence applicable beyond the study settings. Findings will directly inform a practical European toolkit to support maternity services in adopting the programme at scale.

Source: PLoS ONE

DOI: 10.1371/journal.pone.0354394