RT Journal Article
SR Electronic
T1 Healthy Eating and Active Lifestyles for Diabetes (HEAL-D), a culturally tailored self-management education and support program for type 2 diabetes in black-British adults: a randomized controlled feasibility trial
JF BMJ Open Diabetes Research & Care
JO BMJ Open Diab Res Care
FD American Diabetes Association
SP e002438
DO 10.1136/bmjdrc-2021-002438
VO 9
IS 1
A1 Louise M Goff
A1 Carol Rivas
A1 Amanda Moore
A1 Nicholas Beckley-Hoelscher
A1 Fiona Reid
A1 Seeromanie Harding
YR 2021
UL http://drc.bmj.com/content/9/1/e002438.abstract
AB 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.Data are available upon reasonable request. Data are available upon request from the corresponding author.