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][1]. Data are available upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03531177&atom=%2Fbmjdrc%2F9%2F1%2Fe002438.atom

中文翻译：

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糖尿病健康饮食和积极生活方式 (HEAL-D)，一项针对英国黑人成人 2 型糖尿病的文化定制自我管理教育和支持计划：一项随机对照可行性试验

简介 英国黑人社区受 2 型糖尿病 (T2D) 的影响尤为严重。结构化教育计划是 T2D 医疗保健的核心组成部分，但在少数民族人群中效果不佳。因文化而定制的 T2D 教育已证明比常规护理有更大的益处。我们研究的目的是评估糖尿病健康饮食和积极生活方式（“HEAL-D”）文化定制的 T2D 自我管理教育和支持（DSMES）计划的可接受性、保真度和试验可行性。研究设计和方法 在患有 T2D 的英国黑人成人中进行了一项混合方法随机对照可行性试验。参与者按照 1:1 的比例被分配到对照组（常规护理）或干预组（HEAL-D；7 次疗程、14 小时的基于小组文化的定制饮食和生活方式教育、行为改变支持和监督身体活动）。主要结果是招募率和保留率、干预出勤率和完成率。通过观察来评估忠诚度，并与参与者和教育工作者进行定性评估。结果 102 名患者回复邀请函（n=1335）；63 人被随机分配，但 8 人随后因高基线糖化血红蛋白 (HbA1c) 需要强化医疗管理或缺少基线 HbA1c 测量而被视为不符合资格。其余 55 名参与者（27 名干预组，28 名对照组）中，69% 为女性，47% 为非洲人，51% 为加勒比裔。93% 完成了试验，并提供了终点数据。干预出席率很高；85% 完成了该计划（参加 ≥5 次课程），74% 参加 ≥6 次课程。尽管定性评估确定了一些需要改进的结构和格式领域，但干预措施的保真度可以接受。结论 我们已经证明，招募并随机分组患有 T2D 的英国黑人成年人来试验针对文化的 DSMES 计划是可行的。我们已经证明这种干预对于患者和医疗保健提供者来说都是高度可接受的。未来的试验应该评估 HEAL-D 的临床和成本效益。试用注册号[NCT03531177][1]。数据可根据合理要求提供。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03531177&atom=%2Fbmjdrc%2F9%2F1%2Fe002438.atom