TY - JOUR
T1 - The South Asian Healthy Lifestyle Intervention (SAHELI) trial
T2 - Protocol for a mixed-methods, hybrid effectiveness implementation trial for reducing cardiovascular risk in South Asians in the United States
AU - Kandula, Namratha R.
AU - Bernard, Veronica
AU - Dave, Swapna
AU - Ehrlich-Jones, Linda
AU - Counard, Catherine
AU - Shah, Nirav
AU - Kumar, Santosh
AU - Rao, Goutham
AU - Ackermann, Ronald
AU - Spring, Bonnie
AU - Siddique, Juned
N1 - Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/5
Y1 - 2020/5
N2 - 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.
AB - 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.
KW - Cardiovascular
KW - Clinical trial
KW - Implementation
KW - Lifestyle intervention
KW - Mixed-methods
KW - Prevention
KW - South Asian
UR - http://www.scopus.com/inward/record.url?scp=85083290251&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85083290251&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2020.105995
DO - 10.1016/j.cct.2020.105995
M3 - Article
C2 - 32220632
AN - SCOPUS:85083290251
SN - 1551-7144
VL - 92
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 105995
ER -