HEAL-D
Study title
Healthy Eating & Active Lifestyles for Diabetes in African and Caribbean communities (HEAl-D).
Funding and sponsorship
This project is funded by the National Institute of Health Research (NIHR) under its Programme Grants for Applied Research. Additionally, the project is sponsored by University of Leicester.
Background
Type 2 diabetes (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.
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.
To run an internal pilot study, with clear progression criteria, primarily to test recruitment systems;
To test the effectiveness of HEAL-D, compared with standard education programmes, by comparing HbA1c at 12 months between trial arms;
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;
To assess cost effectiveness of HEAL-D;
To assess delivery, implementation, and fidelity in an embedded mixed-methods process evaluation;
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).
Study aims
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.
Study method
Study progress
The study is currently recruiting participants in London.
Study publications
Moore AP, Rivas CA, Harding S, Goff LM. Misalignment: Understanding the challenge of self-management for people living with diabetes in UK Black African and Caribbean communities. Health Education Journal. 2022; 81(6): 679-692. https://doi.org/10.1177/00178969221108563
Goff LM, Rivas C, Moore A, Beckley-Hoelscher N, Reid F, Harding S. Healthy Eating and Active Lifestyles for Diabetes (HEAL-D), a culturally tailored self-management education and support programme for type 2 diabetes in Black-British adults: a randomised controlled feasibility trial. BMJ Open Diab Res Care. 2021 ;9:e002438. https://doi.org/10.1136/bmjdrc-2021-002438
Goff LM, Moore AP, Harding S, Rivas C. Development of Healthy Eating and Active Lifestyles for Diabetes (HEAL-D), a culturally-tailored diabetes self-management education and support programme for black-British adults: a participatory research approach. Diabetic Medicine. 2021;00:e14594. https://doi.org/10.1111/dme.14594
Goff LM, Moore AP, Harding S, Rivas C. Providing culturally sensitive diabetes self-management education and support for Black African and Caribbean communities: a qualitative exploration of the challenges experienced by healthcare practitioners in inner London. BMJ Open Diab Res Care. 2020. 8, 2, e001818. https://doi.org/10.1136/bmjdrc-2020-001818.
Moore AP, Rivas CA, Stanton-Fay S, Harding S, Goff LM. Designing the Healthy Eating and Active Lifestyles for Diabetes (HEAL-D) self-management and support programme for UK African and Caribbean communities: a culturally tailored, complex intervention under-pinned by behaviour change theory. BMC Public Health. 2019. Aug 20;19(1):1146. https://dx.doi.org/10.1186%2Fs12889-019-7411-z
Goff LM, Moore AP, Rivas C, Harding S. Healthy Eating and Active Lifestyles for Diabetes (HEAL-D): study protocol for the design and feasibility trial, with process evaluation, of a culturally-tailored diabetes self-management programme for African-Caribbean communities. BMJ Open. 2019. Mar 1;9(2):e023733. http://dx.doi.org/10.1136/bmjopen-2018-023733.
Lowry S, Goff L, Irwin S, Brady O, Curran N, Lelliott Z, Sevdalis N, Walker A. Mixed-methods implementation study of a virtual culturally tailored diabetes self-management programme for African and Caribbean communities (HEAL-D) in south London and its scaling up across NHS regions in England: study protocol. BMJ Open 2022;12:e067161. http://dx.doi.org/10.1136/bmjopen-2022-067161
Data Protection
Chief Investigator – Professor Louise Goff.
To find out more about our research please contact us at HEAL-D_Study@leicester.ac.uk
For general enquiries please contact us at ldcimplementation@uhl-tr.nhs.uk
Visit the study website: www.heal-d.org