Periodic Reporting for period 3 - IMPACT DIABETES B2B (Implementation Action to prevent Diabetes from Bump 2 Baby (IMPACT DIABETES B2B): a low-resource system of care intervention for appropriate gestational weight gain and improved postnatal outcomes)
Reporting period: 2023-01-01 to 2024-06-30
Gestational diabetes (GDM) is the most common pregnancy complication women experience (1 in 8). About half of those women will develop type 2 diabetes (T2D) within 5-10 years after delivery making it a powerful T2D warning flag. Their children are also at future risk of T2D or obesity later in life. Obesity is a global health problem - ~1 in 2 women now enter pregnancy with overweight or obesity. Obesity/overweight greatly increases a woman’s GDM risk and risk for other complications e.g. stillbirth. Health behaviour change programmes are effective in helping women manage their weight and reduce their diabetes risk, but they are normally delivered outside of pregnancy to older age groups and are costly to run. Health systems are currently not able to provide the necessary support for these women at high risk of developing GDM and future ill health. This created the need to find a low-cost solution that can be run alongside and add value to normal hospital services. The Impact Diabetes Bump2Baby (IDB2B) project is a five-year study focused on supporting women and their babies during and after pregnancy with healthy eating, being active, and getting children off to the best start in life. The project partners span 5 countries (Ireland, the UK, Spain, Denmark, Australia). At the project centre is the ‘Bump2Baby and Me’ (B2B&Me) randomised controlled trial (RCT), which tests an innovative personalised health coaching application and screening process, and its suitability for delivery within routine health service care.
IDB2B’s main objective is to contribute to the early prevention of maternal/child diabetes, overweight/obesity and other chronic health issues (high blood pressure, heart disease, behavioural and learning problems). B2B&Me RCT will enable the collection of important information on: mother and baby health; the project fit within maternity services; its cost; and women's thoughts on the trial. This information is critical to collect and share widely if IDB2B is to be rolled out more widely. We hope the intervention will provide the support that women need at the right time and ultimately deliver improved mother and baby outcomes.
IDB2B’s main objective is to contribute to the early prevention of maternal/child diabetes, overweight/obesity and other chronic health issues (high blood pressure, heart disease, behavioural and learning problems). B2B&Me RCT will enable the collection of important information on: mother and baby health; the project fit within maternity services; its cost; and women's thoughts on the trial. This information is critical to collect and share widely if IDB2B is to be rolled out more widely. We hope the intervention will provide the support that women need at the right time and ultimately deliver improved mother and baby outcomes.
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.
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.
IDB2B aims to demonstrate that the B2B&Me intervention helps to:
● Identify those at highest risk of GDM earlier and support them to better manage their pregnancy
● Support women to improve nutrition and have appropriate GWG
● Enable women in rural and remote settings to access the same care as those women in populated settings
● Reduce GDM-associated risk (e.g. birth complications, stillbirth, maternal morbidity such as hypertensive complications of pre-eclampsia and eclampsia, caesarean section, mortality)
● Reduce maternal obesity risk (e.g. mortality) and associated offspring risks (e.g. macrosomia, intrauterine death, stillbirth)
● Reduce T2D risk
1. IDB2B is unique in integrating evidence-based programmes from existing published interventions into an evidence-based app that can deliver a seamless intervention. This integration is exceptional in the field, builds on the €44.2M global investment in >100 RCTs to date and represents incredible value.
2. The B2B&Me health coaching platform/app delivered focused support to facilitate breastfeeding and health behaviour change, which was lacking in this field. The B2B&Me platform monitored health coach engagement and had the potential to flag declining emotional wellbeing or increasing stress. Health coaches could then preempt these issues and support anticipatory coping resource implementation.
3. The evidence synthesis work from WP1 created a substantial, cutting-edge repository of behaviour change strategies and optimal study designs that have been shared through publication and will continue to be built on with the wider academic communities and health services.
4. High-risk women are the intervention effort focus, and the intervention will have better return on investment than a generic intervention in all pregnant women.
The study will result in 4 key outputs:
● Innovative Healthcare Intervention: the B2B&Me mHealth coaching programme provides coaching for weight management via a smartphone app and real-life health coach
● Implementation Toolkit: information and resources to support B2B&Me implementation and scale up
● Economic model: cost-benefit analysis justification for B2B&Me implementation
● Policy Options: to inform future policy on maternal and early life interventions in the context of GWG and GDM.
The B2B&Me RCT that supports the IDB2B main outputs only finished in October 2023 and the data analysis is ongoing so the key exploitable results are not available yet.
● Identify those at highest risk of GDM earlier and support them to better manage their pregnancy
● Support women to improve nutrition and have appropriate GWG
● Enable women in rural and remote settings to access the same care as those women in populated settings
● Reduce GDM-associated risk (e.g. birth complications, stillbirth, maternal morbidity such as hypertensive complications of pre-eclampsia and eclampsia, caesarean section, mortality)
● Reduce maternal obesity risk (e.g. mortality) and associated offspring risks (e.g. macrosomia, intrauterine death, stillbirth)
● Reduce T2D risk
1. IDB2B is unique in integrating evidence-based programmes from existing published interventions into an evidence-based app that can deliver a seamless intervention. This integration is exceptional in the field, builds on the €44.2M global investment in >100 RCTs to date and represents incredible value.
2. The B2B&Me health coaching platform/app delivered focused support to facilitate breastfeeding and health behaviour change, which was lacking in this field. The B2B&Me platform monitored health coach engagement and had the potential to flag declining emotional wellbeing or increasing stress. Health coaches could then preempt these issues and support anticipatory coping resource implementation.
3. The evidence synthesis work from WP1 created a substantial, cutting-edge repository of behaviour change strategies and optimal study designs that have been shared through publication and will continue to be built on with the wider academic communities and health services.
4. High-risk women are the intervention effort focus, and the intervention will have better return on investment than a generic intervention in all pregnant women.
The study will result in 4 key outputs:
● Innovative Healthcare Intervention: the B2B&Me mHealth coaching programme provides coaching for weight management via a smartphone app and real-life health coach
● Implementation Toolkit: information and resources to support B2B&Me implementation and scale up
● Economic model: cost-benefit analysis justification for B2B&Me implementation
● Policy Options: to inform future policy on maternal and early life interventions in the context of GWG and GDM.
The B2B&Me RCT that supports the IDB2B main outputs only finished in October 2023 and the data analysis is ongoing so the key exploitable results are not available yet.