Healthy Eating & Active Lifestyles for Diabetes (HEAL-D): protocol for a multicentre, pragmatic randomised controlled trial of culturally tailored versus standard diabetes self-management education and support programmes in black African and black Caribbean adults with type 2 diabetes (Preprint)
Authors: Goff Louise M. , Johnson Drusus A , Bell Vicky , Blyden Susan A. , Bower Peter , Dale Jeremy , Harris Tess , Healey Andy , Hoverd Eleanor , Jin Huajie , Kelly Tony , Rivas Carol , Robinson Clare , Thorpe Jayne , Tomlinson Sandra , Ussher Michael , Wahlich Charlotte , McGowan Barbara 
Published: February 2025

BACKGROUND

People of black African and black Caribbean ethnicity experience higher rates and poorer outcomes of type 2 diabetes (T2D) than people of white European ethnicity; these inequalities are compounded by poor healthcare access. Cultural tailoring of diabetes self-management education and support (DSMES) programmes has the potential to improve healthcare engagement and clinical outcomes for minority ethnic groups. Healthy Eating & Active Lifestyles for Diabetes (HEAL-D) is a co-designed culturally tailored DSMES programme for adults of black African and black Caribbean ethnicity. HEAL-D provides group-based education, behaviour change support and participatory physical activity sessions, delivered either face-to-face (F2F) or online. Initial assessments of HEAL-D have demonstrated patient acceptability, but the clinical and cost effectiveness of HEAL-D have yet to be examined.

OBJECTIVE

To evaluate the effectiveness of the HEAL-D intervention, compared to standard DSMES programmes, on glycaemic control (assessed via HbA1c) at 12-months in black African and black Caribbean adults living with T2D.

METHODS

A 24-month, multi-centre, open-label, 2-arm, parallel-group, individually randomised group treatment trial will be conducted, with primary endpoint (HbA1c) assessment at 12-months. Black African and black Caribbean adults with T2D (n=300), recruited from 3-5 centres in the UK (including London, West Midlands and Greater Manchester), will be randomised in a 1:1 ratio to HEAL-D (intervention) or a standard DSMES programme (control). Baseline and follow-up visits (6, 12 and 24-months) will involve collection/measurement of HbA1c, blood lipids, anthropometric outcomes, blood pressure, physical activity, and patient reported outcome measures relating to psychological wellbeing and self-management support, lifestyle behaviours, and health economics. An internal feasibility assessment of recruitment, allocation and treatment engagement will occur in the first 6 months. Cost-effectiveness will be assessed through a cost-utility analysis conducted from a health and social care perspective. A mixed methods process evaluation will provide a formative evaluation of delivery, intervention fidelity and implementation of HEAL-D, and an embedded study within a project (SWAP) will assess the impact of multiple long-term conditions (MLTC) on uptake of HEAL-D, engagement with HEAL-D, and the impact of HEAL-D on MLTC.

RESULTS

The trial received Health Research Authority approval on 22 April 2024. Site ‘green light’ was received on 15 August 2024 for London and 29 November 2024 for Manchester; approvals in the West Midlands are expected January 2025. Recruitment commenced in August 2024 and is due to complete by May 2025. As of 28 January 2025, 36 participants have consented. Last patient, last visit is expected in June 2027; final results are anticipated to be available in September 2027, and publication is expected by the end of 2027.

CONCLUSIONS

The HEAL-D trial will address whether a culturally tailored DSMES programme, provided in-person or online, is clinically and cost-effective compared to standard DSMES at improving diabetes management in black African and black Caribbean adults. If effective, this would provide an evidence-based model of equitable DSMES services and improve the implementation of healthcare programmes for minority ethnic groups.

CLINICALTRIAL

ISCRTN 45319 (24/05/2024).