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

项目摘要 南亚人是美国人口增长第二快的民族，有较高的风险， 与非西班牙裔白人和其他亚洲人相比， 分组。最近的死亡率统计显示，南亚人的心脏病死亡率高于 这些其他种族/族裔群体，表明迫切需要有针对性的公共卫生工作。虽然 对于有心血管疾病风险的个体，建议进行强化饮食和体力活动咨询干预 我们之前的研究发现，现有的生活方式干预措施没有达到南亚人， 这些干预措施没有解决心血管健康的社会和文化决定因素。使用 基于社区的参与性研究，我们开发并试点测试了南亚健康生活方式 干预（SAHELI），一种理论驱动的生活方式干预，整合了基于证据的行为 根据社区的社会文化背景、需求和信仰改变技术。干预措施包括 每周的小组课程，体验活动和动机访谈，以增加自我的组成部分， 调节已被证明是最有效的诱发饮食和身体活动的变化。试点 一项研究（n=63）确定了SAHELI干预的可行性和可接受性，在以下条件下的留存率为100%： 6个月，并显示干预组的体重和血红蛋白A1 c显著改善， 参与者与对照组相比。本研究的目的是进行一项随机 对照试验，以测试SAHELI干预在更大，更普遍的南亚高危人群中的疗效 这是一个非常重要的任务，目的是在人口中进行干预，并收集有关干预措施在现实世界中实施潜力的信息。 我们的主要目的是：1）确定参与SAHELI干预是否与以下因素相关： 与CVD相关的临床危险因素的改善显著更大（收缩压和舒张压的主要结局）， 和舒张压、胆固醇、糖化血红蛋白和体重）与对照组相比， 收到关于健康生活方式的印刷教育材料;以及2）进行多方利益攸关方实施 评估SAHELI的干预措施和社区参与性研究进程。我们 假设SAHELI干预将导致临床风险因素的显著改善 than print打印education教育materials材料at 12 months月.在次要目标中，我们将确定SAHELI对 行为和心理社会结果，并检查干预效果的介质。拟定研究 通过使用有效性和初步实施（1型混合动力）扩展了我们先前的研究 设计，测试临床干预对相关结果的影响，同时观察和收集 关于初步实施的信息。由于缺乏证据表明对南方人的生活方式进行有效干预， 亚洲人有心血管疾病的风险，拟议的研究具有科学和公共卫生意义。

Project Summary South Asians, the second fastest growing ethnic group in the Unites States (U.S.), have an elevated risk of early and aggressive cardiovascular disease (CVD) compared to non-Hispanic Whites and other Asian subgroups. Recent mortality statistics show that South Asians have a higher heart disease mortality rate than these other racial/ethnic groups, suggesting an urgent need for targeted public health efforts. Although intensive diet and physical activity counseling interventions are recommended for individuals with CVD risk factors, our prior research identified that existing lifestyle interventions are not reaching South Asians because these interventions did not address the social and cultural determinants of cardiovascular health. Using community-based participatory research, we developed and pilot-tested the South Asian Healthy Lifestyle Intervention (SAHELI), a theoretically-driven lifestyle intervention that integrates evidence-based behavior change techniques with the community's sociocultural context, needs, and beliefs. The intervention includes weekly group classes, experiential activities, and motivational interviewing to increase the components of self- regulation that have been shown to be most effective for eliciting diet and physical activity changes. The pilot study (n=63) established feasibility and acceptability of the SAHELI intervention, had a 100% retention rate at 6 months, and showed significant improvements in weight and hemoglobin A1c among intervention participants compared to a control group. The goal of the proposed study is to conduct a randomized controlled trial to test the efficacy of the SAHELI intervention in a larger, more generalizable at-risk South Asian population and to collect information on the intervention's potential for implementation in real-world settings. Our Primary Aims 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; and 2) Conduct a multi-stakeholder implementation evaluation to evaluate the SAHELI intervention and community-based participatory research process. We hypothesize that the SAHELI intervention will result in significantly greater improvements in clinical risk factors than print education materials at 12 months. In Secondary Aims, we will determine SAHELI's effect on behavioral and psychosocial outcomes, and examine mediators of intervention effect. The proposed study expands on our prior research by using an effectiveness and preliminary implementation (type 1 hybrid) design, which tests the effects of a clinical intervention on relevant outcomes while observing and gathering information on initial implementation. Given the lack of evidence on effective lifestyle interventions for South Asians at-risk for CVD, the proposed research is of scientific and public health import.