{
  "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.",
  "abstract_shown": true,
  "affiliations": [
    "School of Agriculture and Food Science, University College Dublin, Belfield, Dublin, Ireland",
    "UCD Perinatal Research Centre, University College Dublin and National Maternity Hospital, Dublin, Ireland",
    "Sørlandet Hospital Trust, Kristiansand, Norway",
    "Department of Paediatrics, School of Medicine, University of Granada, Granada, Spain",
    "Instituto de Investigación Biosanitaria de Granada, Granada, Spain",
    "Fundacion para la Investigacion Biosanitaria de Andalucia Oriental, Granada, Spain",
    "Pomeranian Medical University, Szczecin, Poland",
    "University of Agder, Kristiansand, Norway",
    "Western Norway University of Applied Sciences (Høgskulen på Vestlandet), Bergen, Norway",
    "School of Medicine, University College Dublin, Dublin, Ireland",
    "Department of Public Health, Aarhus University, Aarhus, Denmark",
    "Liva Healthcare A/S, Copenhagen, Denmark",
    "UCD School of Public Health, Physiotherapy and Sport Science, University College Dublin, Belfield, Dublin, Ireland"
  ],
  "article_type": "Study Protocol",
  "arxiv": null,
  "author_total": 22,
  "authors": [
    {
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        0
      ],
      "name": "Sharleen L. O’Reilly"
    },
    {
      "affs": [
        1
      ],
      "name": "Thérèse McDonnell"
    },
    {
      "affs": [
        2
      ],
      "name": "Linda Reme Sagedal"
    },
    {
      "affs": [
        3
      ],
      "name": "Mercedes G. Bermúdez"
    },
    {
      "affs": [
        4
      ],
      "name": "Florian Herrmann"
    },
    {
      "affs": [
        5
      ],
      "name": "Hanna Jasiak-Jóźwik"
    },
    {
      "affs": [
        6
      ],
      "name": "Nina Cecilie Øverby"
    },
    {
      "affs": [
        7
      ],
      "name": "Hilde Kristin Refvik Riise"
    },
    {
      "affs": [
        8
      ],
      "name": "Fionnuala McAuliffe"
    },
    {
      "affs": [
        9
      ],
      "name": "Helle T. Maindal"
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    {
      "affs": [
        10
      ],
      "name": "Laura Headley"
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    {
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        11
      ],
      "name": "Cristina Campoy"
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    {
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        12
      ],
      "name": "Sebastian Kwiatkowski"
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    {
      "name": "Ragnhild B. Strandberg"
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    {
      "name": "Anju Rawal"
    },
    {
      "name": "Katie Angotti"
    },
    {
      "name": "Hannah Foley"
    },
    {
      "name": "Lucy Murphy"
    },
    {
      "name": "Lin Chen"
    },
    {
      "name": "Quentin Le Cornu"
    },
    {
      "name": "Marjolein M. Iversen"
    },
    {
      "name": "Timothy Skinner"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/7kcdd4x94ttv3.bib",
  "cited_by": 0,
  "doi": "10.1371/journal.pone.0354394",
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  "licence_label": "CC BY 4.0",
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  "pmcid": null,
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  "published": "2026-08-31",
  "publisher": "Public Library of Science",
  "ris": "https://research.draconitic.com/paper/7kcdd4x94ttv3.ris",
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  "subjects": [
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      "origin": "plos:pediatrics",
      "subfield": "reproductive-child"
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  "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",
  "title_text": "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",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:18:02Z",
  "url": "https://research.draconitic.com/paper/7kcdd4x94ttv3",
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