HEAL-D (Healthy Eating & Active Lifestyles for Diabetes): a multicentre, pragmatic randomised controlled trial comparing effectiveness and cost-effectiveness of culturally tailored versus standard diabetes self-management programmes in Black-African and Black-Caribbean adults with type 2 diabetes

Research question: In adults of African and Caribbean heritage living with type 2 diabetes (T2D), is a culturally tailored diabetes self-management education and support (DSMES) programme provided in person or online effective and cost-effective, in comparison with standard DSMES, at improving glycaemic control (HbA1c) at 12-month follow-up? Background: T2D is a chronic, progressive condition that causes disabling and life-threatening complications. People of African and Caribbean heritage are 2-4 times more likely to develop T2D and to have poorer outcomes than people of White ethnicity. DSMES programmes, provided routinely within NHS care, aim to support people living with T2D to adopt healthful self-management practices. However, they are considerably less successful in minority ethnicities, with lower participation and limited benefit to HbA1c. Culturally tailored DSMES is shown to result in greater improvements in HbA1c, knowledge and quality of life than standard DSMES but there have been no programmes in the UK for people of African and Caribbean heritage. Healthy Eating & Active Lifestyles for Diabetes (‘HEAL-D’) is a culturally tailored DSMES programme for adults of African and Caribbean heritage living with T2D, recently developed with NIHR funding. Aims & objectives: To undertake a pragmatic trial, with internal pilot, comparing HEAL-D, delivered face-to-face (F2F) or online, with standard DSMES for improving HbA1c in adults of African and Caribbean heritage living with T2D. 1. To run an internal pilot study, with clear stop/go trial embedded criteria, primarily to test recruitment systems; 2. To test the effectiveness of HEAL-D, compared with standard DSMES, by comparing HbA1c at 12 months between trial arms; 3. To assess the impact of HEAL-D on secondary outcomes including blood pressure, blood lipids, weight, waist circumference, body fat, quality of life, depressive symptoms, diabetes knowledge, self-efficacy, physical activity, and dietary intake at 6, 12 and 24 months; 4. To assess cost effectiveness of HEAL-D; 5. To assess delivery, implementation, and fidelity in an embedded mixed-methods process evaluation; 6. To assess the impact of multiple long-term conditions (MLTC) on recruitment, engagement with the HEAL-D intervention and the impact of the intervention on MLTC, in an embedded mixed-methods study within a project (SWAP). Methods: pragmatic RCT recruiting 300 adults of African and Caribbean heritage with T2D from London, Greater Manchester and the West Midlands, with an internal pilot, health economic evaluation and process evaluation. Timelines: Total duration 48 months: 5-mth study set-up; 11-mth recruitment; 29-mth follow-up; and 6-mth analysis and dissemination. Anticipated impact & dissemination: we will definitively test the clinical and cost-effectiveness of HEAL-D. If effective, HEAL-D has unique potential to improve NHS DSMES service provision and the health and well-being of people of African and Caribbean heritage living with T2D. We will make recommendations for future implementation and facilitate NHS adoption of HEAL-D, if effective. Results will be disseminated at international conferences and leading journals to reach academic experts, disseminated through NHS networks to reach commissioners/policy makers, and via social media, public engagement events, charity networks and community organisations to reach African and Caribbean communities living with T2D and the general public.