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

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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.