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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.

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.

SUBMITTER: Goff LM

PROVIDER: S-EPMC6398623 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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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.

Goff Louise M LM Moore Amanda P AP Rivas Carol C Harding Seeromanie S

BMJ open 20190301 2

<h4>Introduction</h4>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 ...[more]

PMID: 30826792

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Project description:BackgroundUK African and Caribbean (AfC) communities are disproportionately burdened by type 2 diabetes (T2D). Promoting healthy eating and physical activity through structured education is the cornerstone of T2D care, however cultural barriers may limit engagement in these communities. In addition, changes in lifestyle behaviour are shaped by normative influences within social groups and contextual factors need to be understood to facilitate healthful behaviour change. The Behaviour Change Wheel (BCW) and associated COM-B framework offer intervention designers a systematic approach to developing interventions. The aim of this study was to apply the BCW in the design of a culturally sensitive self-management support programme for T2D in UK AfC communities.MethodsAn intervention development study was conducted. Focus groups were held with 41 AfC patients with T2D to understand healthful weight-management, diet and physical activity behaviours. The COM-B framework and BCW were used to evaluate the qualitative data, identify appropriate behaviour change techniques and specify the intervention components.ResultsParticipants were motivated to avoid diabetes-related consequences although did not always understand the negative impact of their current health behaviours on long-term diabetes outcomes. Barriers to healthful behaviour included gaps in knowledge related to diet, physical activity and weight management guidance. In addition, motivation and social opportunity barriers included an acceptance of larger body sizes, rejection of body mass index for weight guidance and cultural identity being strongly linked to consumption of traditional starches. There was a lack of social opportunity to perform moderate to vigorous physical activity, although walking and dance were culturally acceptable. The resulting Healthy Eating & Active Lifestyles for Diabetes (HEAL-D) intervention uses social support, social comparison, credible sources and demonstration as key behaviour change techniques.ConclusionUse of COM-B and the BCW highlighted the need for an intervention to address motivational and social opportunity barriers to engaging in healthful behaviours, as well as addressing key gaps in knowledge. This framework facilitated the linkage of theoretical behaviour constructs with evidence-based behaviour change techniques, which will enable us to evaluate operationalisation of our chosen BCTs and their impact on behaviour change in a future feasibility study.

Project description:IntroductionBlack-British communities are disproportionately affected by type 2 diabetes (T2D). Structured education programs are a core component of T2D healthcare but they are less successful in people from minority ethnic groups. Culturally tailored T2D education has demonstrated greater benefits than usual care. The aim of our study was to evaluate acceptability, fidelity and trial feasibility of the Healthy Eating and Active Lifestyles for Diabetes ('HEAL-D') culturally tailored T2D self-management education and support (DSMES) program.Research design and methodsA mixed-methods randomized controlled feasibility trial in black-British adults with T2D was conducted. Participants were assigned to control (usual care) or intervention (HEAL-D; 7 sessions, 14 hours of group-based culturally tailored diet and lifestyle education, behavior change support and supervised physical activity), in a ratio of 1:1. Primary outcomes were recruitment and retention rates, intervention attendance and completion. Fidelity was assessed through observations and qualitative evaluation was undertaken with participants and educators.Results102 patients responded to invitation letters (n=1335); 63 were randomized but 8 were subsequently deemed ineligible due to high baseline glycosylated hemoglogin (HbA1c) requiring intensive medical management or missing baseline HbA1c measurement. Of the remaining 55 participants (27 intervention, 28 control), 69% were female, 47% were of African and 51% were of Caribbean ethnicity. 93% completed the trial, providing end point data. Intervention attendance was high; 85% completed the program (attendance at ≥5 sessions), and 74% attended ≥6 sessions. The intervention was delivered with acceptable fidelity, although the qualitative evaluations identified some areas of structure and format in need of refinement.ConclusionsWe have shown it is feasible to recruit and randomize black-British adults with T2D to a trial of a culturally tailored DSMES program. We have shown the intervention is highly acceptable for both patients and healthcare providers. A future trial should assess clinical and cost-effectiveness of HEAL-D.Trial registration numberNCT03531177.

Project description:BackgroundTargeting modifiable lifestyle factors including diet and physical activity represents a potentially cost-effective strategy that could support a growing population of colorectal cancer survivors and improve their health outcomes. Currently, effective, evidence-based interventions and resources helping people after bowel cancer to adopt new lifestyle habits are lacking. The aim of this trial is to test the Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL-ABC) intervention to inform a future definitive randomised controlled trial.Methods/designThis is a feasibility randomised controlled trial. A total of 72 survivors who have completed surgery and all anticancer treatments will be recruited. The intervention group will receive HEAL-ABC resources based on behaviour change theory combined with supportive telephone calls informed by motivational interviewing every 2 weeks during the 3-month intervention, and once a month for 6 months to follow-up. Participants in the control group will follow usual care and have access to resources available in the public domain. The study is testing feasibility of the intervention including adherence and ability to collect data on anthropometry, body composition, diet, physical activity, behaviour change, quality of life, blood markers, contact with healthcare services, morbidities and overall survival.DiscussionThe proposed study will add to the evidence base by addressing an area where there is a paucity of data. This study on lifestyle interventions for people after colorectal cancer follows the Medical Research Council guidance on evaluating complex interventions in clinical practice. It focuses on people living after treatment for colorectal cancer and targets an important research area identified by cancer survivors as a research priority reported by the National Cancer Institute and James Lind Alliance UK.Trial registrationClinicalTrials.gov NCT04227353 approved on the 13th of January 2020.

Dataset Information

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.

Publications

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.

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