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

@article{oreilly2026bump2baby,
  title = {{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}},
  author = {Sharleen L. O’Reilly and Thérèse McDonnell and Linda Reme Sagedal and Mercedes G. Bermúdez and Florian Herrmann and Hanna Jasiak-Jóźwik and Nina Cecilie Øverby and Hilde Kristin Refvik Riise and Fionnuala McAuliffe and Helle T. Maindal and Laura Headley and Cristina Campoy and Sebastian Kwiatkowski and Ragnhild B. Strandberg and Anju Rawal and Katie Angotti and Hannah Foley and Lucy Murphy and Lin Chen and Quentin Le Cornu and Marjolein M. Iversen and Timothy Skinner},
  journal = {PLOS One},
  year = {2026},
  month = aug,
  doi = {10.1371/journal.pone.0354394},
  url = {https://doi.org/10.1371/journal.pone.0354394},
  note = {CC BY 4.0},
}

TY  - JOUR
TI  - 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
AU  - Sharleen L. O’Reilly
AU  - Thérèse McDonnell
AU  - Linda Reme Sagedal
AU  - Mercedes G. Bermúdez
AU  - Florian Herrmann
AU  - Hanna Jasiak-Jóźwik
AU  - Nina Cecilie Øverby
AU  - Hilde Kristin Refvik Riise
AU  - Fionnuala McAuliffe
AU  - Helle T. Maindal
AU  - Laura Headley
AU  - Cristina Campoy
AU  - Sebastian Kwiatkowski
AU  - Ragnhild B. Strandberg
AU  - Anju Rawal
AU  - Katie Angotti
AU  - Hannah Foley
AU  - Lucy Murphy
AU  - Lin Chen
AU  - Quentin Le Cornu
AU  - Marjolein M. Iversen
AU  - Timothy Skinner
PY  - 2026
DA  - 2026/08/31
JO  - PLOS One
DO  - 10.1371/journal.pone.0354394
UR  - https://doi.org/10.1371/journal.pone.0354394
AB  - 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.
SN  - 1932-6203
ER  -