Healthy Eating & Active Lifestyles for Diabetes feasibility trial
Research type
Research Study
Full title
Healthy Eating and Active Lifestyles for Diabetes (HEAL-D): a feasibility trial with process evaluation
IRAS ID
233419
Contact name
Louise Goff
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
2086, Research Registry
Duration of Study in the UK
1 years, 3 months, 29 days
Research summary
In the UK people of African and Caribbean (AfC) ancestry are disproportionately affected by type 2 diabetes (T2D) and it occurs younger, with worse control at diagnosis and it is associated with higher morbidity and poorer outcomes. Healthcare access and engagement is poorer in AfC patients and a number of specific cultural barriers drive poor healthcare access, including deep-rooted trust of medical advice, a strong desire for non-pharmacological therapies and healthcare advice lacking cultural relevance. Robust trials have demonstrated the efficacy of lifestyle interventions in improving glycaemic control, promoting healthy body weight and reducing cardiovascular risk, thus lifestyle education forms the cornerstone of self-management. However, AfC patients report difficulty in translating the advice they receive into their daily lives, particularly regarding traditional foods, commonly consumed in this population. This study will evaluate a culturally tailored lifestyle intervention that has been co-designed over 18 months with AfC patients, in a feasibility trial. Process evaluation methods will be used to evaluate the main elements of the intervention.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/1954
Date of REC Opinion
28 Nov 2017
REC opinion
Favourable Opinion