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

Louise M Goff, Amanda P Moore, Carol Rivas, Seeromanie Harding, Louise M Goff, Amanda P Moore, Carol Rivas, Seeromanie Harding

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 and 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; codesign 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 with 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 and dissemination: This study is funded by a National Institute of Health Research Fellowship (CDF-2015-08-006) and approved by National Health Service 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 number: NCT03531177; Pre-results.

Keywords: culture; diet; education; ethnicity; lifestyle; type 2 diabetes.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Medical Research Council’s framework for the development and evaluation of complex interventions. Reproduced from Craig et al. British Medical Journal. 2008; 337:a1655.
Figure 2
Figure 2
Schematic diagram of phase I: development of HEAL-D using evidence synthesis and codesign methodology to design a culturally tailored self-management programme for T2D in African and Caribbean communities. HEAL-D, Healthy Eating & Active Lifestyles for Diabetes; T2D, type 2 diabetes.
Figure 3
Figure 3
The Capability, Opportunity, Motivation and Behaviour (COM-B) framework and behaviour change wheel; a framework for developing behavioural interventions. Reproduced from Michie S et al. Implementation Science. 2011; 6:42.
Figure 4
Figure 4
Applying the COM-B behaviour change framework to the development of the HEAL-D intervention; identifying theory of change. COM-B, Capability, Opportunity, Motivation and Behaviour; HEAL-D, Healthy Eating and Active Lifestyles for Diabetes.

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