A Complex mHealth Coaching Intervention to Prevent Overweight, Obesity, and Diabetes in High-Risk Women in Antenatal Care: Protocol for a Hybrid Type 2 Effectiveness-Implementation Study

Background Women with overweight and obesity are at higher risk of developing complications in pregnancy such as gestational diabetes and longer-term chronic conditions. Research concerning health behavior change interventions during pregnancy and postpartum shows promising effects, but implementation into routine services is sparsely investigated. Most interventions focus on the antenatal or postpartum life stages, failing to meet the needs of women. IMPACT DIABETES Bump2Baby is a multicenter project across 4 high-income countries developed to test the implementation of an antenatal and postpartum evidence-based mobile health (mHealth) coaching intervention called Bump2Baby and Me (B2B&Me) designed to sit alongside usual care in the perinatal period. Objective We aim to explore the feasibility and implementation of the B2B&Me intervention and investigate the effectiveness of this intervention in women at risk of gestational diabetes. Methods IMPACT DIABETES Bump2Baby is a hybrid type 2 effectiveness-implementation study, which integrates an evidence-based mHealth coaching app that includes personalized health behavior change coaching provided by health care professionals alongside antenatal care from the first antenatal visit to 12 months postpartum. The mHealth app offers the possibility of synchronous calls, asynchronous contact (including coach-participant text and video messaging exchanges tailored to the participant’s needs), and ongoing access to an extensive library of bespoke intervention materials. Participants will interact asynchronously with their health coach throughout the intervention via the app. This randomized controlled trial across 4 clinical sites within Ireland, the United Kingdom, Spain, and Australia will recruit 800 women in early pregnancy to evaluate the effectiveness on postpartum weight. The Exploration, Preparation, Implementation, and Sustainment implementation framework is the theoretical underpinning of the study. The implementation evaluation will be assessed at the individual, hospital staff, and broader community levels using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources for the RE-AIM evaluation will include app and platform analytics, screening and training records, participant medical records, key informant interviews, participant and partner exit interviews, cost data, study questionnaires, staff surveys, and blood sample analyses. Results The study was approved and registered with the Australian New Zealand Clinical Trials Registry on November 19, 2020. Recruitment commenced on February 9, 2021, and data collection is ongoing. Publication of the results is expected in 2024. Conclusions This is the first hybrid effectiveness-implementation study of an 18-month mHealth coaching intervention in at-risk women that we are aware of. As research aims to move toward real-world implementable solutions, it is critical that hybrid studies are conducted. The data from this large multicenter study will be useful in planning the potential implementation and scale-up of evidence-based perinatal health behavior change interventions. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12620001240932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380020&isReview=true International Registered Report Identifier (IRRID) DERR1-10.2196/51431

IMPACT DIABETES B2B will demonstrate the real-world implementation of an evidence-based, low-resource system-level intervention for healthy gestational weight gain and early prevention of maternal and child diabetes, overweight and obesity when delivered 'at scale' across antenatal settings.Gestational diabetes affects up to 18% of pregnancies worldwide and is an increasing health problem for both mothers and babies.By identifying those most at risk of developing gestational diabetes and working with them through personalised health coaching delivered via smartphone App, this project will engage, motivate and empower this target group to lead healthier lives for improved wellbeing and pregnancy outcomes.This project will demonstrate implementation within 3 European countries and Australia with clear line-of-sight on future scale-up across different contexts and resource settings via its innovative implementation toolkit and workshops for dissemination and exploitation.Pregnancy is a unique time in life with potential to influence maternal health, and the health of the next generation.IMPACT DIABETES B2B delivers breakthrough research in nutrition, exercise and behaviour change leading to an implementable low-resource system-level intervention.The personalised feedback will empower women to manage their health, delivering cost-effective management of excess gestational and post-pregnancy weight gain to: improve pregnancy and postpartum outcomes; improve utilisation of healthcare services; and encourage ongoing maternal health with sustainable impact for mother and family.Expertise in implementation science, lifestyle change, health psychology, mHealth technology, health economics and health service delivery will lead this mixed methods project.The project will co-design the intervention system, with end-user context and management explored throughout.The work will evaluate clinical, economic and implementation outcomes to inform future practice and policy.The proposal addresses the criterion very well, but with a small number of shortcomings.The proposal is in line with the call and is important for the improvement of maternal and child health.The objectives of the proposal are welldefined.The concept is sound, novel and practical.The proposed methodology is strong.There is a clear interdisciplinary approach, with a solid evaluation plan.All cross-cutting priorities are generally very well addressed.All intervention components are previously tested and the risk screening tool has been validated.The different intervention components build on already available evidence and go beyond the state of the art.Nevertheless, the proposal did not provide sufficient details on the potential role that men/partners might have in the decision-making process related to pregnancy.It was unclear whether local cultures and gender dynamics would be explored as a potential barrier or facilitator.There was a lack of details on and rationale for the cost-effectiveness analysis, given the lack of clear hypotheses on savings and QALY gains.

Evaluation Summary Report
Criterion 2 -Impact Score: 4.00 (Threshold: 4/5.00 , Weight: -) The following aspects will be taken into account: The extent to which the outputs of the project would contribute to each of the expected impacts mentioned in the work The proposal has a developed and credible dissemination and communication plan that reaches all target audiences (from end-users to policy makers) and includes open access, IPR management, and data management.However, equity was not sufficiently addressed, without a specific focus on the needs of disadvantaged or vulnerable groups.Additionally to different languages, the structural factors at macro-, meso-and micro-levels such as cultural differences and different policies should have been better addressed and as such, the transferability of findings to non-High Income Countries remains insufficiently described in the proposal.The sustainability of the intervention after the project end was unclear.
Criterion 3 -Quality and efficiency of the implementation Score: 4.50 (Threshold: 3/5.00 , Weight: -) The following aspects will be taken into account: Quality and effectiveness of the work plan, including extent to which the resources assigned to work packages are in line with their objectives and deliverables Appropriateness of the management structures and procedures, including risk and innovation management Complementarity of the participants and extent to which the consortium as a whole brings together the necessary expertise Appropriateness of the allocation of tasks, ensuring that all participants have a valid role and adequate resources in the project to fulfil that role The proposal addresses the criterion very well, but with small shortcomings.The proposed implementation plan is almost excellent.The team proposed a solid, multi-level intervention with partners of proven expertise in the field.The activities to implement the proposed project are laid out clearly in nine work packages, the sequence and approach of each being well grounded in implementation research theory.The consortium as a whole has the expertise and wide experience in similar complex interventions, with a well-established distribution of leads and tasks.The roles and responsibilities of each consortium member are wellarticulated across these work packages.Gender balance and management structure are appropriate and sufficiently described.
For the allocation of roles and resources, the estimated person months for WP 2 may not be enough to develop the main technology platform (App and Health Coaching Library) needed for the proposed project.This document is digitally sealed.The digital sealing mechanism uniquely binds the document to the modules of the Funding & Tenders Portal of the European Commission, to the transaction for which it was generated and ensures its integrity and authenticity.

Scope of the proposal
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The proposal fails to address the criterion or cannot be assessed due to missing or incomplete information.1 Poor.The criterion is inadequately addressed, or there are serious inherent weaknesses.2Fair.The proposal broadly addresses the criterion, but there are significant weaknesses.3 Good.The proposal addresses the criterion well, but a number of shortcomings are present.4 Very good.The proposal addresses the criterion very well, but a small number of shortcomings are present.5 Excellent.The proposal successfully addresses all relevant aspects of the criterion.Any shortcomings are minor.Ref. Ares(2019)4951190 -29/07/2019 Score: 4.00 (Threshold: 4/5.00 , Weight: -) The following aspects will be taken into account, to the extent that the proposed work corresponds to the topic description in the work programme: Clarity and pertinence of the objectives Soundness of the concept, and credibility of the proposed methodology Extent that proposed work is beyond the state of the art, and demonstrates innovation potential (e.g.ground-breaking objectives, novel concepts and approaches, new products, services or business and organisational models) Appropriate consideration of interdisciplinary approaches and, where relevant, use of stakeholder knowledge and gender dimension in research and innovation content case the proposal is out of scope) Not provided Operational Capacity Status: Operational Capacity: Yes If No, please list the concerned partner(s), the reasons for the rejection, and the requested amount.Ref. Ares(2019)4951190 -29/07/2019 Exceptional funding of third country participants/international organisationsA third country participant/international organisation not listed in General Annex A to the Main Work Programme may exceptionally receive funding if their participation is essential for carrying out the project (for instance due to outstanding expertise, access to unique know-how, access to research infrastructure, access to particular geographical environments, possibility to involve key partners in emerging markets, access to data, etc.).( For more information, see the Online Manual )Based on the information provided in the proposal, we consider that the following participant(s)/international organisation(s) that requested funding should exceptionally be funded: (Please list the Name and acronym of the applicant, Reasons for exceptional funding and the Requested grant amount.)NotprovidedBased on the information provided in the proposal, we consider that the following participant(s)/international organisation(s) that requested funding should NOT be funded: (Please list the Name and acronym of the applicant, Reasons for exceptional funding and the Requested grant amount.)state whether the use of hESC is, or is not, in your opinion, necessary to achieve the scientific objectives of the proposal and the reasons why.Alternatively, please state if it cannot be assessed whether the use of hESC is necessary or not because of a lack of information.Ref.Ares(2019)4951190 -29/07/2019 Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË -Tel.+32 22991111

programme under the relevant topic Any substantial impacts not mentioned in the work programme, that would enhance innovation capacity, create new market opportunities, strengthen competitiveness and growth of companies, address issues related to climate change or the environment, or bring other important benefits for society Quality of the proposed measures to: -exploit and disseminate the project results (including management of IPR), and to manage research data where relevant -communicate the project activities to different target audiences
The proposal addresses the criterion very well, although certain improvements are still possible.The expected impacts are generally well addressed.Overall, the proposal addresses effectively the knowledge-do gap of interventions for decreasing Body Mass Index (BMI) in pregnant and postpartum women up to one year.The proposed approach is considered innovative.The focus across the 1000 days is permitting a continuity of care from pregnancy into the postpartum period.The project will provide a good understanding of what works and what does not when implementing the intervention.The engagement strategy and segmentation of the target key audiences were clearly described.It directly contributes to the achievement of SDG2 and SDG3.