Title: Healthy Eating and Active Lifestyle for Diabetes (HEAL-D): development, implementation and process evaluation of a culturally appropriate diabetes lifestyle intervention
Funder: Department of Health and Social Care

Abstract: Background In the UK people of African and Caribbean (AfC) ancestry are disproportionately affected by type 2 diabetes (T2D); it occurs younger, with worse control at diagnosis and is associated with higher morbidity and poorer outcomes. Diet and lifestyle education forms the cornerstone of T2D management in primary care however specific cultural barriers may limit healthcare access and contribute to poorer outcomes for AfC patients. Culturally appropriate healthcare that is respectful of, and responsive to, the health beliefs, practices and needs of diverse patients is proposed as a principal way to address healthcare disparities and is identified as a priority by patients. Culturally-tailored lifestyle programmes are more effective in T2D management than standard education but to date have only been developed for Black communities in the USA. Aims This research aims to develop and evaluate the feasibility of delivering an evidence-based, culturally-tailored, community-based diet and lifestyle intervention for managing T2D among AfC patients in primary care, prior to the design of a full-scale trial. Design and methods A two-phase programme of research is proposed using a mixed-methods approach. In Phase 1 the intervention will be developed; participatory methods (focus groups, interviews and workshops) will be used to engage and establish collaboration with key stakeholders (patients, care providers and community leaders) in the intervention planning process. The intervention will aim to deliver a programme of education and behaviour change counselling based on the UK evidence-based nutrition guidelines and the general structure of the programme will be drawn from successful interventions in America. Participatory methods will identify the adaptations that are needed to ensure cultural sensitisation of the intervention by working with key stakeholders to identify the barriers and facilitators to motivating and engaging AfC patients in health education and behaviour change. In Phase 2 the culturally-tailored diet and lifestyle intervention will be delivered and evaluated in a small feasibility trial. Eighty patients with T2D will be recruited from GP practices, and randomly assigned to either the intervention (40 patients) or control (standard care; 40 patients). A range of outcome measures (HbA1c, lipids, body weight, blood pressure, diet and activity practices and knowledge) will be assessed at baseline and endpoint to inform sample size calculations for a subsequent trial. Process evaluation, guided by the RE-AIM framework, will be undertaken using quantitative and qualitative data to understand successful and unsuccessful components of the intervention,assess fidelity and quality of the intervention, and identify contextual factors associated with variation in outcomes, implementation and patient responses. The findings will be used to inform the design of, and funding application for, a subsequent full-scale trial of culturally-appropriate lifestyle versus standard care for T2D in AfC patients. Potential benefits for patients and the NHS This research is based on the overarching hypothesis that culturally-tailored lifestyle interventions will improve patient acceptability and be more effective in achieving T2D management targets in AfC patients than standard care. Tackling inequalities in health and improving healthcare access for high risk, hard to reach' communities is a NHS priority; this research aims to address this need and develop a programme of lifestyle education and behaviour change support specifically tailored to engage AfC communities, that will improve the T2D self-management practices of AfC patients.

Lay abstract: In the UK rates of type 2 diabetes (T2D) are particularly high in people of African and Caribbean (AfC) ethnicity, and these patients are more likely to experience complications of diabetes. Diet and lifestyle education are a core part of diabetes care however there is evidence that cultural barriers exist that result in AfC patients being less likely than other patients to access available healthcare, which may contribute to their poorer diabetes outcomes. Diet and lifestyle education that has been adapted to specific cultural health beliefs and practices has been shown to be more effective than standard education in diabetes management in Black communities in America; such programmes have not yet been developed in the UK but are identified as a priority by patient groups. This research aims to develop a culturally-tailored diet and lifestyle intervention for diabetes, specifically for AfC patients, and assess the feasibility of delivering it in primary care. The intervention will aim to deliver a programme of education and behaviour change counselling based on the UK evidence-based nutrition guidelines and the general structure of the programme will be drawn from successful interventions in America. A two-phase programme of research will be conducted. The first phase is a development phase in which patients, GPs, nurses, dietitians and leaders from AfC community groups in Lambeth, Southwark and Lewisham will participate in focus groups, interviews and workshops aiming to foster collaboration and engagement in planning and developing the intervention; these methods have been previously shown to improve engagement of hard to reach' communities. Participants will be encouraged to discuss what factors motivate, and what factors are barriers to making lifestyle changes and what adaptations are needed to ensure the intervention is culturally tailored and acceptable to AfC patients. In the workshops details of the intervention will be developed, considering where and how the intervention will be delivered and what are the best ways to engage patients with health education and behaviour change. The second phase will consist of a small pilot' study to assess the feasibility of delivering the intervention to AfC T2D patients in primary care prior to designing a full-scale definitive trial. Eighty patients with T2D will be recruited from GP practices, and randomly assigned to receive either the intervention (40 patients) or continue receiving standard care (40 patients). Patients will have measures of diabetes control, cardiovascular risk, body weight, diet and activity behaviours and knowledge, and quality of life collected at the start and end of the study to evaluate the effects of the intervention. Additionally data will be collected to assist the researchers in understanding the successful and unsuccessful components of the intervention, for example who did and did not participate, what factors were barriers and what factors facilitated participation, to help in planning a larger scale study. It is anticipated that a culturally-adapted programme of diet and lifestyle advice for T2D will increase patient acceptability and engagement, bringing about healthful behaviours and improved diabetes management.

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: METABOLIC AND ENDOCRINE