The project started by collecting, extracting, and synthesising all current evidence from the literature to inform B2B&Me RCT development. This resulted in an integrated antenatal and postnatal framework to support the trial implementation. Qualitative interviews with key healthcare professionals investigated GDM and appropriate gestational weight gain (GWG) knowledge and challenges for each country. A co-created B2B&Me RCT version of the LIVA platform was developed with a comprehensive health coaching manual and content library in both English and Spanish. A mapping protocol and tool for the Exploration Preparation Implementation Sustainment (EPIS) framework assessment was developed and applied to the contextual mapping of sites, which analysed the factors with potential to influence IDB2B implementation. An online survey of antenatal and postnatal maternity services healthcare professionals (HCPs) was conducted to gather data on standard practice and protocols for identifying and managing women with GDM and ensuring appropriate GWG. Survey data analysis and dissemination plans are underway. Fidelity monitoring processes were established and will continue for the trial duration. The RCT protocol was published in Trials, the implementation protocol in JMIR Research Protocols and the health economic analysis protocol in BMJ Open. The integrated data analysis plan for the trial was submitted as a deliverable to the EU.
During reporting period (RP) 3, the independent trial monitor (UCPH) completed the monitoring of ethical compliance as all clinical sites (Ireland, UK, Spain, and Australia) closed out the RCT during 2023. The final number of completed RCT participants is 585. Data collection was completed on the NUID UCD secure online platform by early 2024 following the completion of the blood samples analyses. NUID UCD locked the database and completed the data cleaning. Numerous materials were developed to facilitate IDB2B communications, dissemination and exploitation (B2B&Me logo/branding, project website, Twitter, YouTube and LinkedIn accounts, standard slides with key messages/graphics, infographics, language guide, and HCP flyer). The project has continued to raise stakeholder awareness via social media posts, articles, blogs, participant newsletters and conference presentations. During RP3, the IDB2B exploitation plan was updated, and the tools/materials continue to be refined. Two successful implementation forums were held to engage policy and healthcare stakeholders during RP3. All required project documents were delivered to a high standard and all partners were supported with timely deliverables submission and milestone achievement.
