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South Asian Healthy Lifestyle Initiative (SAHELI)

Community Translation of the South Asian Healthy Lifestyle Intervention

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03336255
Acronym
SAHELI
Enrollment
550
Registered
2017-11-08
Start date
2018-03-15
Completion date
2023-02-24
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor

Brief 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.

Interventions

BEHAVIORALSouth Asian Healthy Lifestyle Initiative (SAHELI)

Culturally tailored lifestyle intervention for South Asians.

Sponsors

Northwestern University
Lead SponsorOTHER
Metropolitan Asian Family Services
CollaboratorUNKNOWN
Skokie Health Department
CollaboratorUNKNOWN
Endeavor Health
CollaboratorOTHER
Case Western Reserve University
CollaboratorOTHER
Shirley Ryan AbilityLab
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* South Asian adults (18-65 years) * Living within the 22 square mile study area * Ability to understand Hindi, Urdu, Gujarati or English. AND Body Mass Index of 25 and over and a diagnosis by a doctor of high cholesterol or pre-diabetes/Diabetes, or High blood pressure. OR Body Mass Index of 23 to 24.9 and one clinical risk factors for Cardiovascular Disease (CVD) (CVD risk factors are: Hypertension (Systolic blood pressure \>=130 or diastolic blood pressure \>=80), abnormal cholesterol (Total cholesterol ≥200, triglycerides \>=150),pre-diabetes (A1c between 5.7-6.4%), or diabetes (A1c 6.5 to 10.9),

Exclusion criteria

* History of a CVD event (stroke or heart attack) * Being on insulin * Blood pressure ≥180/100 mmHg * HbA1c ≥11% BMI ≥ 40 * Current pregnancy * Being ≤ 12 months postpartum * Any underlying diseases likely to limit lifespan and/or affects ability to exercise.

Design outcomes

Primary

MeasureTime frameDescription
Participants who receive SAHELI intervention may show greater reduction in clinical risk factors for cardiovascular disease compared to the control group.12 monthsTotal of 550 participants with 50% randomized to SAHELI intervention arm will show significantly greater improvements in clinical risk factors associated with Cardio Vascular Disease (primary outcomes of systolic and diastolic blood pressure, cholesterol, glycated hemoglobin, and weight) relative to a comparison group that receives print education materials on healthy lifestyle.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNamratha Kandula, MD,MPH

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026