Department of General Internal Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, 10th Floor, Chicago, IL 60611, USA.
Contemp Clin Trials. 2013 Nov;36(2):479-87. doi: 10.1016/j.cct.2013.09.007. Epub 2013 Sep 21.
Disseminating and implementing evidence-based, cardiovascular disease (CVD) prevention lifestyle interventions in community settings and in ethnic minority populations is a challenge. We describe the design and methods for the South Asian Heart Lifestyle Intervention (SAHELI) study, a pilot study designed to determine the feasibility and initial efficacy of a culturally-targeted, community-based lifestyle intervention to improve physical activity and diet behaviors among medically underserved South Asians (SAs). Participants with at least one CVD risk factor will be randomized to either a lifestyle intervention or a control group. Participants in both groups will be screened in a community setting and receive a primary care referral after randomization. Intervention participants will receive 6weeks of group classes, followed by 12weeks of individual telephone support where they will be encouraged to initiate and maintain a healthy lifestyle goal. Control participants will receive their screening results and monthly mailings on CVD prevention. Primary outcomes will be changes in moderate/vigorous physical activity and saturated fat intake between baseline, 3-, and 6-month follow-up. Secondary outcomes will be changes in weight, clinical risk factors, primary care visits, self-efficacy, and social support. This study will be one of the first to pilot-test a lifestyle intervention for SAs, one of the fastest growing racial/ethnic groups in the U.S. and one with disparate CVD risk. Results of this pilot study will provide preliminary data about the efficacy of a lifestyle intervention on CVD risk in SAs and inform community-engaged CVD prevention efforts in an increasingly diverse U.S. population.
在社区环境和少数民族群体中传播和实施基于证据的心血管疾病（CVD）预防生活方式干预是一项挑战。我们描述了南亚心脏生活方式干预（SAHELI）研究的设计和方法，该研究是一项旨在确定针对特定文化的、基于社区的生活方式干预措施在改善医疗服务不足的南亚人（SAs）的身体活动和饮食行为方面的可行性和初步效果的试点研究。至少有一个 CVD 风险因素的参与者将被随机分配到生活方式干预组或对照组。两组参与者都将在社区环境中进行筛查，并在随机分组后接受初级保健转诊。干预组参与者将接受 6 周的小组课程，然后接受 12 周的个人电话支持，鼓励他们开始并维持健康的生活方式目标。对照组参与者将收到他们的筛查结果和每月关于 CVD 预防的邮件。主要结果将是基线、3 个月和 6 个月随访时中度/剧烈体力活动和饱和脂肪摄入量的变化。次要结果将是体重、临床风险因素、初级保健就诊、自我效能和社会支持的变化。这项研究将是第一个针对南亚人进行生活方式干预的试点研究之一，南亚人是美国增长最快的种族/族裔群体之一，他们的 CVD 风险存在差异。这项试点研究的结果将提供关于生活方式干预对南亚人 CVD 风险影响的初步数据，并为美国日益多样化的人口中的社区参与 CVD 预防工作提供信息。
