The South Asian Heart Lifestyle Intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: Design and methods

Disseminating and implementing evidence-based, cardiovascular disease (CVD) prevention lifestyle interventions in community settings and in ethnic minority populations is a challenge. We describe the design and methods for the South Asian Heart Lifestyle Intervention (SAHELI) study, a pilot study designed to determine the feasibility and initial efficacy of a culturally-targeted, community-based lifestyle intervention to improve physical activity and diet behaviors among medically underserved South Asians (SAs). Participants with at least one CVD risk factor will be randomized to either a lifestyle intervention or a control group. Participants in both groups will be screened in a community setting and receive a primary care referral after randomization. Intervention participants will receive 6. weeks of group classes, followed by 12. weeks of individual telephone support where they will be encouraged to initiate and maintain a healthy lifestyle goal. Control participants will receive their screening results and monthly mailings on CVD prevention. Primary outcomes will be changes in moderate/vigorous physical activity and saturated fat intake between baseline, 3-, and 6-month follow-up. Secondary outcomes will be changes in weight, clinical risk factors, primary care visits, self-efficacy, and social support. This study will be one of the first to pilot-test a lifestyle intervention for SAs, one of the fastest growing racial/ethnic groups in the U.S. and one with disparate CVD risk. Results of this pilot study will provide preliminary data about the efficacy of a lifestyle intervention on CVD risk in SAs and inform community-engaged CVD prevention efforts in an increasingly diverse U.S. population.