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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 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 550 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03336255
The ClinicalTrials.gov registry entry for NCT03336255 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which South Asian Healthy Lifestyle Initiative (SAHELI) is the first listed.
NCT03336255 reports 0 study locations.
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.
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