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South Asian Healthy Lifestyle Initiative (SAHELI)

Study acronym: SAHELI
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Results posted: Oct 15, 2026 Show 4 more changesShow less
    • Primary endpoints: 1 to 5
    • Eligibility criteria expanded, about 10 words
    • Collaborators: 5 to 6
    • Publications: details revised at 4 of 4 entries
  2. Minor Re-verified, no change to tracked fieldsv12
  3. Minor Study site revised
    • Publications: 2 to 4
    v11
  4. Minor Eligibility criteria shortened, about 1 wordv10
  5. Minor Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Mar 31, 2023 to Feb 11, 2023
    • Study completion date changed from estimate of May 31, 2023 to Feb 24, 2023
    • Start date: Mar 1, 2018 to Mar 15, 2018
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Primary completion date: May 31, 2022 to Mar 31, 2023v8
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  3. Notable Primary completion date: May 31, 2021 to May 31, 2022
    • Study completion date: May 31, 2021 to May 31, 2023
    • Publications: details revised at 1 of 2 entries
    v6
  4. Minor Re-verified, no change to tracked fieldsv5
  5. Minor Eligibility criteria expanded, about 19 wordsv4
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  7. Minor Eligibility criteria expanded, about 1 wordv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03336255
Lead Sponsor Northwestern University
Collaborators: Metropolitan Asian Family Services, Skokie Health Department, Endeavor Health, Case Western Reserve University, Shirley Ryan AbilityLab, National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Cardiovascular Risk Factor
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov