HEAL-D Trial: evaluation of clinical and cost effectiveness

In the summer of 2023, we will commence a multicentre, randomised controlled trial of HEAL-D.

Research question: In adults of Black-African and Black-Caribbean ethnicity living with type 2 diabetes (T2D), is a culturally tailored diabetes self-management education and support programme provided in person or online effective and cost-effective, in comparison with standard diabetes education programmes, at improving glycaemic control (HbA1c) at 12-months follow-up?

Background: T2D is a chronic, progressive condition that causes disabling and life-threatening complications. People of Black-African and Black-Caribbean ethnicity are 2-4 times more likely to develop T2D and to have poorer outcomes than people of White ethnicity. diabetes self-management education and support 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 ethnic groups, with lower participation and limited benefit to HbA1c. Culturally tailored diabetes self-management education and support programmes are shown to result in greater improvements in HbA1c, knowledge and quality of life than standard programmes but there have been no programmes in the UK for people of Black-African and Black-Caribbean ethnicity. Healthy Eating & Active Lifestyles for Diabetes (‘HEAL-D’) is a culturally tailored diabetes self-management education and support programme for Black-African and Black-Caribbean adults 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 diabetes education programmes for improving HbA1c in adults of Black-African and Black-Caribbean ethnicity living with T2D.

1. To run an internal pilot study, with clear progression criteria, primarily to test recruitment systems;
2. To test the effectiveness of HEAL-D, compared with standard education programmes, 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 randomised controlled trial recruiting 300 adults of Black-African and Black-Caribbean ethnicity with T2D from London, Manchester and the West Midlands. Participants will be individually randomised to HEAL-D or the standard programme that is commissioned locally; following allocation participants will choose which mode of attendance, F2F or online, they wish to receive. An internal pilot in the first 6 months of the trial will assess recruitment and engagement. The primary outcome will be assessed at 12 months follow-up and secondary outcomes at 6 and 24 months. Process evaluation will assess intervention delivery, fidelity and implementation. Health economic evaluation will be conducted to assess incremental cost effectiveness of both F2F and online delivery of HEAL-D and the cost effectiveness of delivering the programme at scale.