Feinberg School of Medicine, Division of General Internal Medicine, Northwestern University, Chicago, IL, United States; Feinberg School of Medicine, Department of Preventive Medicine, Northwestern University, Chicago, IL, United States.
Feinberg School of Medicine, Division of General Internal Medicine, Northwestern University, Chicago, IL, United States.
Contemp Clin Trials. 2020 May;92:105995. doi: 10.1016/j.cct.2020.105995. Epub 2020 Mar 24.
Intensive lifestyle interventions targeting diet and physical activity are recommended for reducing atherosclerotic cardiovascular disease (ASCVD) risk in adults. However, existing interventions often do not reach immigrant populations because of a mismatch between the social, cultural, and environmental context of immigrants and Western bio behavioral models which underpin evidence-based lifestyle interventions. The South Asian Healthy Lifestyle Intervention (SAHELI) study is a type 1 hybrid design randomized controlled trial aimed at reducing ASCVD risk in South Asian Americans, a group at higher ASCVD risk than whites and other Asian Americans. The objective is to evaluate the clinical effectiveness and implementation potential of a community-based, culturally-adapted lifestyle intervention for South Asian adults. Participants (n = 550) will be randomized to printed healthy lifestyle education materials or SAHELI, a group-based lifestyle change program that includes weekly classes for 16 weeks and 4 booster classes though month 11. SAHELI integrates evidence-based behavior change strategies with culturally-adapted strategies and group motivational interviewing to improve diet, physical activity, and stress management. Follow-up assessments will occur at 6 and 12 months. We hypothesize that the SAHELI intervention group will have greater improvements in clinical ASCVD risk factors (weight, blood pressure, glycated hemoglobin, and lipids), physical activity, and psychosocial outcomes than the print material group at 6- and 12- months. We will use mixed-methods to examine SAHELI's potential for reach, adoption, implementation, and maintenance from the perspective of multiple stakeholders. This study offers the potential to increase the reach and effectiveness of evidence-based lifestyle interventions for South Asian adults at increased risk for ASCVD.
针对饮食和身体活动的强化生活方式干预措施被推荐用于降低成年人的动脉粥样硬化性心血管疾病（ASCVD）风险。然而，由于移民的社会、文化和环境背景与基于证据的生活方式干预措施所依据的西方生物行为模式之间存在不匹配，现有的干预措施往往无法覆盖移民群体。南亚健康生活方式干预（SAHELI）研究是一项 1 型混合设计随机对照试验，旨在降低南亚裔美国人的 ASCVD 风险，该人群的 ASCVD 风险高于白人和其他亚裔美国人。目的是评估基于社区的、文化适应的生活方式干预措施对南亚成年人降低 ASCVD 风险的临床效果和实施潜力。参与者（n=550）将被随机分配到接受印刷的健康生活方式教育材料或 SAHELI，SAHELI 是一种基于群体的生活方式改变计划，包括 16 周的每周课程和 4 次强化课程，直到第 11 个月。SAHELI 将基于证据的行为改变策略与文化适应策略和群体动机性访谈相结合，以改善饮食、身体活动和压力管理。随访评估将在 6 个月和 12 个月时进行。我们假设，与接受印刷材料的组相比，SAHELI 干预组在 6 个月和 12 个月时，临床 ASCVD 风险因素（体重、血压、糖化血红蛋白和血脂）、身体活动和心理社会结局的改善幅度更大。我们将采用混合方法，从多个利益相关者的角度评估 SAHELI 的可及性、采用、实施和维持的潜力。这项研究有可能提高针对 ASCVD 风险增加的南亚成年人的基于证据的生活方式干预措施的可及性和有效性。
