ImportanceSouth Asian adults in the US experience excess cardiovascular disease (CVD) compared with other racial and ethnic groups. The effectiveness and reach of guideline-recommended lifestyle interventions have not been evaluated in this population.ObjectiveTo evaluate whether a culturally adapted, group lifestyle intervention will improve CVD risk factors more effectively than written health education materials among US South Asian adults.Design, Setting, and ParticipantsThis single-blind randomized clinical trial was conducted from March 6, 2018, to February 11, 2023 at community sites in the Chicago, Illinois, metropolitan area. South Asian adults aged 18 to 65 years who were overweight or obese, had no history of CVD events, and had at least 1 additional CVD risk factor (hypertension, dyslipidemia, prediabetes, or diabetes) were eligible for inclusion.InterventionA 16-week, culturally adapted, group-based lifestyle intervention led by community health coaches. Lifestyle modification counseling was delivered in English, Gujarati, Hindi, and Urdu. Participants tracked their diet and physical activity (PA) and received 4 optional group maintenance sessions between months 5 and 11 of follow-up. The intervention was delivered in person prior to the onset of the COVID-19 pandemic and via videoconference starting in March 2020. The control group received written health education materials, delivered monthly.Main Outcomes and MeasuresPrimary outcomes were the between-group differences in CVD risk factor changes from baseline to 12 months, including weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), glycated hemoglobin (HbA1c), and total cholesterol, estimated using multivariate mixed-effects regression models. Secondary outcomes were self-reported diet quality, PA, and self-efficacy, estimated using univariate mixed-effects regression models.ResultsAmong 549 randomized participants, 318 (57.9%) were women, and mean (SD) participant age was 49.2 (9.5) years. Mean differences in CVD risk factor changes from baseline to 12 months in the intervention vs control group were calculated for weight (mean difference, −0.07 kg; 95% CI, −0.55 to 0.42), SBP (mean difference, 0.47 mm Hg; 95% CI, −1.85 to 2.79), DBP (mean difference, 0.44 mm Hg; 95% CI, −1.06 to 1.95), cholesterol (mean difference, −2.47 mg/dL; 95% CI, −8.51 to 3.57), and HbA1c (mean difference, −0.07%; 95% CI −0.20% to 0.07%). Intervention participation was associated with greater improvements in dietary quality, PA, and self-efficacy than control.Conclusions and RelevanceIn the SAHELI randomized clinical trial, a culturally adapted, group lifestyle intervention was not more effective than written health education materials for CVD risk factor reduction among US South Asian adults, but the intervention was associated with small improvements in self-reported health behaviors. Effective CVD prevention interventions for this elevated-risk population require further investigation.Trial RegistrationClinicalTrials.gov Identifier: NCT03336255

中文翻译：

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针对有心血管危险因素的南亚成年人的文化适应生活方式干预


重要性与其他种族和族裔群体相比，美国的南亚成年人患有超额心血管疾病 （CVD）。尚未在该人群中评估指南推荐的生活方式干预的有效性和范围。目的评估在美国南亚成年人中，文化适应的集体生活方式干预是否比书面健康教育材料更有效地改善 CVD 危险因素。设计、设置和参与者这项单盲随机临床试验于 2018 年 3 月 6 日至 2023 年 2 月 11 日在伊利诺伊州芝加哥大都会区的社区站点进行。年龄在 18 至 65 岁之间、超重或肥胖、无 CVD 事件史且至少有 1 个其他 CVD 危险因素（高血压、血脂异常、糖尿病前期或糖尿病）的南亚成年人符合纳入条件。干预由社区健康教练领导的为期 16 周、适应文化、以团体为基础的生活方式干预。生活方式改变咨询以英语、古吉拉特语、印地语和乌尔都语提供。参与者跟踪他们的饮食和身体活动 （PA），并在随访的第 5 个月和第 11 个月之间接受了 4 次可选的小组维护课程。该干预是在 COVID-19 大流行开始之前亲自进行的，并从 2020 年 3 月开始通过视频会议进行。对照组每月收到书面健康教育材料。主要结局和指标主要结局是 CVD 危险因素变化从基线到 12 个月的组间差异，包括体重、收缩压 （SBP）、舒张压 （DBP）、糖化血红蛋白 （HbA1c） 和总胆固醇，使用多变量混合效应回归模型估计。 次要结局是自我报告的饮食质量、 PA 和自我效能感，使用单变量混合效应回归模型估计。结果在 549 名随机参与者中，318 名 （57.9%） 为女性，平均 （SD） 参与者年龄为 49.2 （9.5） 岁。计算干预组与对照组从基线到 12 个月 CVD 危险因素变化的平均差异，包括体重（平均差，-0.07 kg;95% CI，-0.55 至 0.42）、收缩压（平均差，0.47 毫米汞柱;95% CI，-1.85 至 2.79）、DBP（平均差，0.44 毫米汞柱;95% CI，-1.06 至 1.95）、胆固醇（平均差、 −2.47 毫克/分升;95% CI，-8.51 至 3.57）和 HbA1c（平均差，-0.07%;95% CI -0.20% 至 0.07%）。与对照组相比，干预参与与饮食质量、PA 和自我效能感的更大改善相关。结论和相关性在 SAHELI 随机临床试验中，在美国南亚成年人中，文化适应的团体生活方式干预在降低 CVD 危险因素方面并不比书面健康教育材料更有效，但该干预与自我报告的健康行为的小幅改善相关。针对这一高危人群的有效 CVD 预防干预措施需要进一步研究。试验注册临床试验。gov 标识符： NCT03336255