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NCT03336255 · ClinicalTrials.gov registry record · NA
South Asian Healthy Lifestyle Initiative (SAHELI)
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 550
- Enrollment target
NCT03336255: Completed NA study, sponsored by Northwestern University.
NCT03336255 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 550 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03336255, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 550 participants
- Enrollment target
Study 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 SAH
Primary Outcome
Total 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.
Interventions
- BEHAVIORAL South Asian Healthy Lifestyle Initiative (SAHELI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2018-03-15 |
| Est. Completion | 2023-02-24 |
| Phase | NA |
What the finished NCT03336255 record still lists
NCT03336255 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which South Asian Healthy Lifestyle Initiative (SAHELI) is the first listed.
NCT03336255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03336255 about?
NCT03336255 is a clinical study titled "South Asian Healthy Lifestyle Initiative (SAHELI)". 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...
What is the current status of trial NCT03336255?
This trial is currently completed. It is a NA study. The enrollment target is 550 participants. The study started on 2018-03-15. Estimated completion is 2023-02-24.
What interventions are being tested in trial NCT03336255?
The interventions under investigation include: South Asian Healthy Lifestyle Initiative (SAHELI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03336255?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03336255's enrollment target sits among peer trials
550 184th of 2000 higher than 1,815 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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