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Randomized Controlled Trial
. 2013 Nov;36(2):479-87.
doi: 10.1016/j.cct.2013.09.007. Epub 2013 Sep 21.

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

Namratha R Kandula  1 , Yasin Patel, Swapna Dave, Paola Seguil, Santosh Kumar, David W Baker, Bonnie Spring, Juned Siddique
Affiliations
Randomized Controlled Trial

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

Namratha R Kandula et al. Contemp Clin Trials. 2013 Nov.

Abstract

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 6weeks of group classes, followed by 12weeks 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.

Trial registration: ClinicalTrials.gov NCT01647438.

Keywords: Cardiovascular disease prevention; Culture; Lifestyle intervention; Randomized control trial; South Asian.

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Figures

Figure 1
Figure 1
Multidimensional framework used to develop the South Asian Heart Lifestyle Intervention (SAHELI). Adapted from: Glass TA, McAtee MJ. Behavioral science at the crossroads in public health: Extending horizons, envisioning the future. Social Science & Medicine. 2006;62(7):1650–1671
Figure 2
Figure 2
Study overview.
See this image and copyright information in PMC

References

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