Introduction Black-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 methods A 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.
Results 102 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.
Conclusions We 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 number NCT03531177.
- type 2 diabetes
Data availability statement
Data are available upon reasonable request. Data are available upon request from the corresponding author.
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Contributors All authors have made substantial contributions to this study. LMG, CR and SH were responsible for the conception and design of the study. LMG, CR, SH and AM developed the protocol and study approach. LMG and AM undertook data collection. LMG, CR and AM undertook qualitative data analysis. FR and NB-H undertook statistical analysis. LMG drafted the manuscript. All authors read, revised and approved the final manuscript. LMG is guarantor.
Funding This report is independent research arising from a Career Development Fellowship (Louise M. Goff, CDF-2015-08-006) supported by the National Institute for Health Research. LMG and AM are supported by the National Institute for Health Research (NIHR) Applied Research Collaboration South London at King’s College Hospital NHS Foundation Trust. FR and NB-H are supported by the NIHR Biomedical Research Centre based at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London.
Disclaimer The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. The funder had no role in the study design, data collection, data analysis, data interpretation or writing of the report.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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