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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

Research output: Contribution to journalArticle

Original languageEnglish
Pages (from-to)e023733
JournalBMJ Open
Volume9
Issue number2
Early online date1 Mar 2019
DOIs
Publication statusPublished - Jun 2019

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King's Authors

Abstract

Introduction Black-British communities are disproportionately burdened by type 2 diabetes (T2D) and its complications. Tackling these inequalities is a priority for healthcare providers and patients. Culturally-tailored diabetes education provides long-term benefits superior to standard care but to date such programmes have only been developed in the USA. The current programme of research aims to develop the Healthy Eating and Active Lifestyles for Diabetes (HEAL-D) culturally-tailored T2D self-management programme for Black-British communities; and to evaluate its delivery, acceptability and the feasibility of conducting a future effectiveness trial of HEAL-D. Methods & analysis Informed by Medical Research Council Complex Interventions guidance this research will rigorously develop and evaluate the implementation of the HEAL-D intervention to understand the feasibility of conducting a full-scale effectiveness trial. In Phase 1 the intervention will be developed. The intervention curriculum will be based on existing evidence-based T2D guidelines for diet and lifestyle management; co-design methods will be used to foster community engagement, identify the intervention’s underpinning theory; identify the optimal structure, format and delivery methods, ascertain adaptations that are needed to ensure cultural sensitivity, and understand issues of implementation. In Phase 2 the intervention will be delivered and compared to usual care in a feasibility trial. Process evaluation methods will evaluate the delivery and acceptability of HEAL-D. The effect size of potential primary outcomes, such as HbA1c and body weight will be estimated. The feasibility of conducting a future effectiveness trial will also be evaluated, particularly feasibility of randomisation, recruitment, retention, and contamination. Ethics & dissemination This study is funded by a National Institute of Health Research Fellowship (CDF-2015-08-006), and approved by NHS Research Ethics Committee (17-LO-1954). Dissemination will be through national and international conferences, peer-reviewed publications and local and national clinical diabetes networks. Trial Registration: this trial is registered with www.clinicaltrials.gov, identifier: NCT03531177.

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