Supplement for Community Translation of the South Asian Healthy Lifestyle Intervention (SAHELI)

项目摘要 南亚健康生活方式干预(Saheli)是一项正在进行的1型混合随机对照研究 该试验招募了550名有心血管危险因素的南亚裔美国成年人，并正在测试 为期16周的以社区为基础、适应文化的生活方式干预或简短的健康生活方式教育可以 显著改善心血管危险因素。该研究已完成注册，并寻求12个项目的资金 额外几个月以完成后续成果评估、执行评估、收尾、分析、 和演示文稿/出版物。本行政副刊由首席调查员(PI)Namratha领导 Kandula，医学博士，公共卫生硕士，将协调所有注册后的活动，以实现 学习。Saheli试验是南亚裔美国人中规模最大的生活方式干预试验 这具有不成比例的心血管疾病风险，而且预防干预措施无法达到这一点。 这项行政补编的经费将支持完成141个月的6个月和12个月的后续行动 研究参与者、持续收集执行结果、数据库锁定、研究分析 假设、报告、出版和向科学和社区利益相关者传播试验结果。 Saheli审判具体目的是：1)确定参与Saheli干预是否 与心血管疾病相关的临床风险因素显著改善相关(主要 收缩和舒张压、胆固醇、糖化血红蛋白和体重的结果)与 对照组，在12个月时接受关于健康生活方式的印刷教育材料；以及2)进行 多个利益攸关方实施评估，以评估萨赫里干预和社区为基础 参与式研究过程。在次级目标中，我们将确定萨赫利对行为和 心理社会结局，并检验干预效果的中介因素。对证据的需求还没有得到满足- 改善饮食和体力活动并降低老年人心血管疾病风险的干预措施 美国南亚人口。鉴于南亚缺乏有效和公平的生活方式干预措施 有心血管疾病风险的美国人，完成这项拟议的研究是科学和公众的 健康进口。

Project Summary The South Asian Healthy Lifestyle Intervention (SAHELI) is an ongoing Type 1 Hybrid randomized controlled trial that has enrolled 550 South Asian American adults with cardiovascular risk factors and is testing whether a 16-week community-based, culturally adapted lifestyle intervention or brief healthy lifestyle education can significantly improve cardiovascular risk factors. The study has completed enrollment and seeks funding for 12 additional months to complete follow-up outcome assessments, implementation evaluation, closeout, analysis, and presentations/publications. This administrative supplement is led by Principal Investigator (PI) Namratha Kandula, MD, MPH who will coordinate all post-enrollment activities to accomplish the scientific aims of the study. The SAHELI trial is the largest lifestyle intervention trial among South Asian Americans, a population that has a disproportionate risk of cardiovascular disease and is not being reached by prevention interventions. The funds from this administrative supplement will support completion of 6- and 12-month follow-up for 141 study participants, ongoing collection of implementation outcomes, database lock, analyses of study hypotheses, reporting, publication, and dissemination of trial results to scientific and community stakeholders. The Specific Aims of that SAHELI trial are to: 1) Determine whether participation in the SAHELI intervention is associated with significantly greater improvements in clinical risk factors associated with CVD (primary outcomes of systolic and diastolic blood pressure, cholesterol, glycated hemoglobin, and weight) relative to a comparison group that receives print education materials on healthy lifestyle at 12 months; and 2) Conduct a multi-stakeholder implementation evaluation to evaluate the SAHELI intervention and community-based participatory research process. In Secondary Aims, we will determine SAHELI's effect on behavioral and psychosocial outcomes, and examine mediators of intervention effect. There is an unmet need for evidence- based interventions that improve diet and physical activity and reduce cardiovascular disease risk among the U.S. South Asian population. Given the lack of effective and equitable lifestyle interventions for South Asian Americans at-risk for cardiovascular disease, completing the proposed research is of scientific and public health import.