CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 550 enrolled / 550 target
Drug / intervention
South Asian Healthy Lifestyle Initiative (SAHELI)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03336255
NCT03336255N/ACompletedHigh Momentum (5.5/mo)Completion was 40mo ago

Community Translation of the South Asian Healthy Lifestyle Intervention

Northwestern University·interventional·Posted Nov 8, 2017·Updated Jun 25, 2026

In Brief

A clinical study evaluating South Asian Healthy Lifestyle Initiative (SAHELI) for Cardiovascular Risk Factor. Completed, enrolled 550 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

Research show that South Asians (SA) have a high burden of Cardiovascular Disease (CVD) risk factors of which, poor diet and physical inactivity remain the major lifestyle risk factors in SA. Intensive diet and physical activity behavioral interventions have been shown to yield improvements across a variety of intermediate cardiovascular health outcomes (blood pressure, cholesterol, glycated hemoglobin, weight) in persons with CVD risk factors and are recommended by national guidelines. However, the investigators prior research found that existing interventions are not reaching SA. First, the usual framing of behavioral risk factor interventions in terms of the biomedical model of CVD is mismatched to SA explanatory models, which emphasize psychosocial causes of CVD. Next, few interventions are tailored to the sociocultural patterns shared by much of the SA community. Interventions that address the individual and shared sociocultural drivers of CVD risk are needed to maximize reach and effectiveness in the high risk and rapidly growing SA population. The proposed study builds on the strong foundation of the South Asian Healthy Lifestyle Initiative (SAHELI), which has a 9-year history of using community-based participatory research to design and test culturally tailored, community-based interventions to reduce CVD disparities in SA. To date, SAHELI has engaged multi-sectoral partners, established relationships of trust, and defined mutually beneficial goals. The investigators also culturally adapted the SAHELI lifestyle intervention to (a) address the individual and sociocultural determinants of CVD risk in SA; and (b) increase components of self-regulation (motivation, self-monitoring, goal setting) that are most effective in eliciting diet and physical activity changes. Hence, the SAHELI intervention integrates evidence-based behavior change techniques with the shared the sociocultural processes salient to SA. A pilot study (n=63) established feasibility of the SAHELI intervention, had a 100% retention rate, and reduced glycated hemoglobin and weight among intervention participants compared to a control group. The proposed study is based on the pilot study and will use a hybrid trial type 1 design to evaluate the clinical effectiveness and implementation potential of the culturally tailored, community-based lifestyle intervention in a larger, more generalizable at-risk SA population. Study team is uniquely positioned to fill a critical gap in work (a) demonstrating the cultural adaptation of evidence-based lifestyle interventions, and (b) evaluating the effectiveness of the SAHELI intervention in reducing CVD risk in SA living in the U.S.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 8, 2017
Enrollment StartMar 15, 2018
Primary CompletionFeb 11, 2023
Study CompletionFeb 24, 2023
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.7 years ago

Arms & Interventions

Print Health Educationno_intervention

Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.

SAHELI Interventionexperimental

Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 16 to 20 participants who will attend 16 weekly, 90 minute group education sessions at Metropolitan Asian Family Services or Skokie Health Department. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management.

Behavioral: South Asian Healthy Lifestyle Initiative (SAHELI)

Interventions

South Asian Healthy Lifestyle Initiative (SAHELI)behavioral

Culturally tailored lifestyle intervention for South Asians.