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

南亚健康生活方式干预 (SAHELI) 社区翻译补充材料

• 批准号: 10588670
• 负责人: NAMRATHA R KANDULA
• 金额: $ 15.46万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10588670
• 关键词: Administrative Supplement; Adult; Asian Americans; Asian population; Behavioral; Cholesterol; Collection; Communities; Data; Databases; Diastolic blood pressure; Diet; Education; Enrollment; Evidence based intervention; Funding; Glycosylated Hemoglobin; Hybrids; Intervention; Intervention Studies; Intervention Trial; Knowledge; Mediator of activation protein; Outcome; Outcome Assessment; Participant; Physical activity; Population; Principal Investigator; Process; Public Health; Publications; Randomized Controlled Trials; Reporting; Research; Risk Factors; South Asian; Testing; Translations; Weight; base; cardiovascular disorder risk; cardiovascular health; cardiovascular risk factor; clinical risk; community based participatory research; comparison group; ethnic minority; follow-up; health equity; healthy lifestyle; high risk; implementation evaluation; implementation outcomes; improved; intervention effect; lifestyle intervention; preventive intervention; primary outcome; psychosocial; racial minority

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.

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， 这项试验招募了550名有心血管危险因素的南亚裔美国成年人， 16-一周基于社区的、适应文化的生活方式干预或简短的健康生活方式教育， 显著改善心血管危险因素。该研究已完成招募，并寻求资助12 额外几个月完成后续成果评估、执行情况评价、收尾、分析， 和出版物。本行政补充材料由主要研究者（PI）Namratha负责 Kandula，医学博士，公共卫生硕士，他将协调所有入学后的活动，以实现本项目的科学目标。 study. SAHELI试验是在南亚裔美国人中进行的最大的生活方式干预试验， 这类人群患心血管疾病的风险过高，预防干预措施尚未触及。 这笔行政补助金的资金将支持完成141名患者的6个月和12个月随访。 研究参与者、持续收集实施结果、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试验的具体目的是：1）确定是否参与SAHELI干预， 与CVD相关的临床风险因素（原发性 收缩压和舒张压、胆固醇、糖化血红蛋白和体重）相对于 在12个月时接受健康生活方式印刷教育材料的对照组;以及2）进行 多方利益攸关方执行情况评价，以评价SAHELI干预措施和基于社区的 参与式研究过程。在次要目标中，我们将确定SAHELI对行为和 心理社会结果，并检查干预效果的调解人。对证据的需求还没有得到满足- 改善饮食和身体活动，降低心血管疾病风险的干预措施 美国南亚人口。由于缺乏有效和公平的生活方式干预， 美国人在心血管疾病的风险，完成拟议的研究是科学和公共 健康进口。