{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T18:13:56Z","timestamp":1788200036890,"version":"build-2803163510"},"reference-count":39,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T00:00:00Z","timestamp":1788134400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Transforming Health and Care Systems, EU Horizon Europe Research and Innovation Programme.","award":["EU Horizon Europe Research and Innovation Programme."],"award-info":[{"award-number":["EU Horizon Europe Research and Innovation Programme."]}]},{"DOI":"10.13039\/100010414","name":"Health Research Board","doi-asserted-by":"publisher","award":["THCS-2024-1"],"award-info":[{"award-number":["THCS-2024-1"]}],"id":[{"id":"10.13039\/100010414","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100012774","name":"Innovation Fund Denmark","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100012774","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100005632","name":"Narodowe Centrum Bada\u0144 i Rozwoju","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005632","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100005416","name":"Norges Forskningsr\u00e5d","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005416","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100023731","name":"Consejer\u00eda de Salud y Consumo, Junta de Andaluc\u00eda","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100023731","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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&amp;Me) was a mobile health (mHealth) coaching intervention provided to women at-risk of GDM from early pregnancy through to 1-year postpartum. B2B&amp;Me Plus (B2B&amp;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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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\u2019s primary objective is to evaluate reach, adoption, implementation and maintenance of the B2B&amp;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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                    <jats:p>\n                      This study was registered with ClinicalTrials.gov (NCT07189221) on 28 August 2025 (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT07189221?cond=diabetes\" xlink:type=\"simple\">https:\/\/clinicaltrials.gov\/study\/NCT07189221?cond=diabetes<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0354394","type":"journal-article","created":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T17:24:31Z","timestamp":1788197071000},"page":"e0354394","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Bump2Baby &amp; Me+ (B2B&amp;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"],"prefix":"10.1371","volume":"21","author":[{"given":"Sharleen L.","family":"O\u2019Reilly","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5890-3689","authenticated-orcid":true,"given":"Th\u00e9r\u00e8se","family":"McDonnell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Reme Sagedal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mercedes G.","family":"Berm\u00fadez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3383-0874","authenticated-orcid":true,"given":"Florian","family":"Herrmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2007-9011","authenticated-orcid":true,"given":"Hanna","family":"Jasiak-J\u00f3\u017awik","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1871-041X","authenticated-orcid":true,"given":"Nina Cecilie","family":"\u00d8verby","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilde Kristin","family":"Refvik Riise","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fionnuala","family":"McAuliffe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helle T.","family":"Maindal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Headley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Campoy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Kwiatkowski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ragnhild B.","family":"Strandberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-7500-4009","authenticated-orcid":true,"given":"Anju","family":"Rawal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Angotti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Foley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Murphy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-9362-8734","authenticated-orcid":true,"given":"Quentin","family":"Le Cornu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9954-171X","authenticated-orcid":true,"given":"Marjolein M.","family":"Iversen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"Skinner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2026,8,31]]},"reference":[{"issue":"5","key":"pone.0354394.ref001","doi-asserted-by":"crossref","first-page":"1196","DOI":"10.1111\/dom.14966","article-title":"Lifestyle intervention for the prevention of type 2 diabetes in women with prior gestational diabetes: A systematic review and meta-analysis","volume":"25","author":"M Retnakaran","year":"2023","journal-title":"Diabetes Obes Metab"},{"key":"pone.0354394.ref002","unstructured":"International Diabetes Federation. Diabetes Atlas. 2025."},{"key":"pone.0354394.ref003","article-title":"Progression to type 2 diabetes in women with a known history of gestational diabetes: systematic review and meta-analysis","volume":"369","author":"E Vounzoulaki","year":"2020","journal-title":"BMJ"},{"key":"pone.0354394.ref004","doi-asserted-by":"crossref","DOI":"10.3945\/ajcn.110.001032","article-title":"Effect of dietary and lifestyle factors on the risk of gestational diabetes: review of epidemiologic evidence","volume":"94","author":"C Zhang","year":"2011","journal-title":"Am J Clin Nutr"},{"issue":"12","key":"pone.0354394.ref005","article-title":"Overweight and obesity are associated with clustering of metabolic risk factors in early pregnancy and the risk of GDM","volume":"14","author":"IW Yen","year":"2019","journal-title":"PLoS One"},{"issue":"6","key":"pone.0354394.ref006","doi-asserted-by":"crossref","first-page":"1357","DOI":"10.1097\/01.AOG.0000188387.88032.41","article-title":"Maternal outcomes in 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Centre for Health Research and Implementation. Personal GDM for lifestyle intervention: A Web-Based, Data-Driven Prediction Tool. 2025. Available from: https:\/\/lifestyle.personalgdm.com\/"},{"issue":"10","key":"pone.0354394.ref022","doi-asserted-by":"crossref","DOI":"10.2196\/28622","article-title":"Reach Outcomes and Costs of Different Physician Referral Strategies for a Weight Management Program Among Rural Primary Care Patients: Type 3 Hybrid Effectiveness-Implementation Trial","volume":"5","author":"G Porter","year":"2021","journal-title":"JMIR Form Res"},{"issue":"3","key":"pone.0354394.ref023","doi-asserted-by":"crossref","first-page":"535","DOI":"10.1177\/0038038509103208","article-title":"Implementing, embedding, and integrating practices: an outline of normalization process theory","volume":"43","author":"C May","year":"2009","journal-title":"Sociology"},{"issue":"10491","key":"pone.0354394.ref024","article-title":"SPIRIT 2025 statement: updated guideline for protocols of randomised trials","volume":"405","author":"A-W Chan","year":"2025","journal-title":"Lancet"},{"key":"pone.0354394.ref025","article-title":"Standards for Reporting Implementation Studies (StaRI) Statement","volume":"356","author":"H Pinnock","year":"2017","journal-title":"BMJ"},{"key":"pone.0354394.ref026","doi-asserted-by":"crossref","first-page":"112630","DOI":"10.1016\/j.psychres.2019.112630","article-title":"Reprint of: An introduction to effectiveness-implementation hybrid designs","volume":"283","author":"SJ Landes","year":"2020","journal-title":"Psychiatry Res"},{"key":"pone.0354394.ref027","unstructured":"Medisana GmbH. BS 444 connect body analysis scale."},{"key":"pone.0354394.ref028","doi-asserted-by":"crossref","first-page":"248","DOI":"10.1016\/0749-5978(91)90022-L","article-title":"Social cognitive theory of self-regulation","volume":"50","author":"A Bandura","year":"1991","journal-title":"Organ Behav Hum Decis Process"},{"issue":"1","key":"pone.0354394.ref029","doi-asserted-by":"crossref","first-page":"68","DOI":"10.1037\/0003-066X.55.1.68","article-title":"Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being","volume":"55","author":"RM Ryan","year":"2000","journal-title":"Am Psychol"},{"issue":"3","key":"pone.0354394.ref030","doi-asserted-by":"crossref","first-page":"276","DOI":"10.1037\/h0088437","article-title":"Transtheoretical therapy: Toward a more integrative model of change","volume":"19","author":"JO Prochaska","year":"1982","journal-title":"Psychotherapy Theor Res Pract"},{"key":"pone.0354394.ref031","unstructured":"Re-AIM. Why Use Re-AIM? Available from: https:\/\/re-aim.org\/learn\/why-use-re-aim\/"},{"key":"pone.0354394.ref032","volume-title":"A costing guidebook for implementation scientists","author":"J Cronin","year":"2023"},{"key":"pone.0354394.ref033","doi-asserted-by":"crossref","DOI":"10.1093\/oso\/9780195108248.001.0001","volume-title":"Cost-effectiveness in health and medicine","author":"MR Gold","year":"1996"},{"key":"pone.0354394.ref034","doi-asserted-by":"crossref","unstructured":"Raghavan R, Brownson R, Colditz G, Proctor E. The role of economic evaluation in dissemination and implementation research. Dissemination and implementation research in health: Translating science to practice. 2012. p. 113.","DOI":"10.1093\/acprof:oso\/9780199751877.003.0005"},{"issue":"1","key":"pone.0354394.ref035","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1186\/s13012-021-01172-6","article-title":"Cost data in implementation science: categories and approaches to costing","volume":"17","author":"HT Gold","year":"2022","journal-title":"Implement Sci"},{"key":"pone.0354394.ref036","doi-asserted-by":"crossref","first-page":"112433","DOI":"10.1016\/j.psychres.2019.06.008","article-title":"Economic evaluation in implementation science: Making the business case for implementation strategies","volume":"283","author":"AB Eisman","year":"2020","journal-title":"Psychiatry Res"},{"issue":"1","key":"pone.0354394.ref037","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1186\/s13012-021-01143-x","article-title":"Implementation science issues in understanding, collecting, and using cost estimates: a multi-stakeholder perspective","volume":"16","author":"AB Eisman","year":"2021","journal-title":"Implement Sci"},{"issue":"6","key":"pone.0354394.ref038","first-page":"470","article-title":"The burden of the \u201cfalse\u2010negatives\u201d in clinical development: analyses of current and alternative scenarios and corrective measures","volume":"10","author":"T Burt","year":"2017","journal-title":"Clin Transl Res"},{"key":"pone.0354394.ref039","unstructured":"European Medicines Agency. 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