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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

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
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

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.

culture, diet, education, ethnicity, lifestyle, type 2 diabetes
2044-6055
e023733
Goff, Louise M.
a55fb373-dbb5-4b5d-81db-90b3c430257f
Moore, Amanda P.
cc74a35b-cb3c-44ef-b7d2-fccf00b86fc9
Rivas, Carol
040bfbc1-0aef-4826-ab58-e85743fea9d4
Harding, Seeromanie
758456ca-c9f0-409a-9477-4565af0ae769
Goff, Louise M.
a55fb373-dbb5-4b5d-81db-90b3c430257f
Moore, Amanda P.
cc74a35b-cb3c-44ef-b7d2-fccf00b86fc9
Rivas, Carol
040bfbc1-0aef-4826-ab58-e85743fea9d4
Harding, Seeromanie
758456ca-c9f0-409a-9477-4565af0ae769

Goff, Louise M., Moore, Amanda P., Rivas, Carol and Harding, Seeromanie (2019) 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, 9 (2), e023733. (doi:10.1136/bmjopen-2018-023733).

Record type: Article

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.

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Accepted/In Press date: 8 January 2019
Published date: 1 March 2019
Keywords: culture, diet, education, ethnicity, lifestyle, type 2 diabetes

Identifiers

Local EPrints ID: 429016
URI: http://eprints.soton.ac.uk/id/eprint/429016
ISSN: 2044-6055
PURE UUID: 615f6788-4796-4b99-a89b-f147b93f7494

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Date deposited: 19 Mar 2019 17:30
Last modified: 06 Oct 2020 22:46

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