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. 2020 May:92:105995.
doi: 10.1016/j.cct.2020.105995. Epub 2020 Mar 24.

The South Asian Healthy Lifestyle Intervention (SAHELI) trial: Protocol for a mixed-methods, hybrid effectiveness implementation trial for reducing cardiovascular risk in South Asians in the United States

Namratha R Kandula  1 , Veronica Bernard  2 , Swapna Dave  3 , Linda Ehrlich-Jones  4 , Catherine Counard  5 , Nirav Shah  6 , Santosh Kumar  7 , Goutham Rao  8 , Ronald Ackermann  9 , Bonnie Spring  10 , Juned Siddique  11
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The South Asian Healthy Lifestyle Intervention (SAHELI) trial: Protocol for a mixed-methods, hybrid effectiveness implementation trial for reducing cardiovascular risk in South Asians in the United States

Namratha R Kandula et al. Contemp Clin Trials. 2020 May.

Abstract

Intensive lifestyle interventions targeting diet and physical activity are recommended for reducing atherosclerotic cardiovascular disease (ASCVD) risk in adults. However, existing interventions often do not reach immigrant populations because of a mismatch between the social, cultural, and environmental context of immigrants and Western bio behavioral models which underpin evidence-based lifestyle interventions. The South Asian Healthy Lifestyle Intervention (SAHELI) study is a type 1 hybrid design randomized controlled trial aimed at reducing ASCVD risk in South Asian Americans, a group at higher ASCVD risk than whites and other Asian Americans. The objective is to evaluate the clinical effectiveness and implementation potential of a community-based, culturally-adapted lifestyle intervention for South Asian adults. Participants (n = 550) will be randomized to printed healthy lifestyle education materials or SAHELI, a group-based lifestyle change program that includes weekly classes for 16 weeks and 4 booster classes though month 11. SAHELI integrates evidence-based behavior change strategies with culturally-adapted strategies and group motivational interviewing to improve diet, physical activity, and stress management. Follow-up assessments will occur at 6 and 12 months. We hypothesize that the SAHELI intervention group will have greater improvements in clinical ASCVD risk factors (weight, blood pressure, glycated hemoglobin, and lipids), physical activity, and psychosocial outcomes than the print material group at 6- and 12- months. We will use mixed-methods to examine SAHELI's potential for reach, adoption, implementation, and maintenance from the perspective of multiple stakeholders. This study offers the potential to increase the reach and effectiveness of evidence-based lifestyle interventions for South Asian adults at increased risk for ASCVD.

Trial registration: ClinicalTrials.gov NCT03336255.

Keywords: Cardiovascular; Clinical trial; Implementation; Lifestyle intervention; Mixed-methods; Prevention; South Asian.

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Figures

Fig. 1.
Fig. 1.
Multilevel Drivers of Cardiovascular Risk in South Asians in the United States
Fig. 2.
Fig. 2.
Study Flow and Procedures
See this image and copyright information in PMC

References

    1. South Asian Americans Leading Together: A Demographic Snapshot of South Asians in the United States. http://saalt.org/wp-content/uploads/2012/09/Demographic-Snapshot-Asian-A... In.; Accessed on 9/18/18.
    1. Volgman: Atherosclerotic Cardiovascular Disease in South Asians in the United States: Epidemiology, Risk Factors, and Treatments: A Scientific Statement From the American Heart Association (vol 138, pg e1, 2018). Circulation 2018, 138(5):E76–E76. - PubMed
    1. Gujral UP, Vittinghoff E, Mongraw-Chaffin M, Vaidya D, Kandula NR, Allison M, Carr J, Liu K, Narayan KMV, Kanaya AM: Cardiometabolic Abnormalities Among Normal-Weight Persons From Five Racial/Ethnic Groups in the United States: A Cross-sectional Analysis of Two Cohort Studies. Ann Intern Med 2017, 166(9):628–636. - PMC - PubMed
    1. Kanaya AM, Herrington D, Vittinghoff E, Ewing SK, Liu K, Blaha MJ, Dave SS, Qureshi F, Kandula NR: Understanding the high prevalence of diabetes in U.S. south Asians compared with four racial/ethnic groups: the MASALA and MESA studies. Diabetes care 2014, 37(6):1621–1628. - PMC - PubMed
    1. Talegawkar SA, Jin Y, Kandula NR, Kanaya AM: Cardiovascular health metrics among South Asian adults in the United States: Prevalence and associations with subclinical atherosclerosis. Prev Med 2017, 96:79–84. - PMC - PubMed

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