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Implementation of a Peer Leader-facilitated Dyadic Intervention

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Study completion date changed from estimate of Jul 2025 to Jun 28, 2026 Show 9 more changesShow less
    • Results posted: Sep 24, 2026
    • Completed without a posted recruiting period
    • Final enrollment: 44 participants (planned 80)
    • Study sites: 0 to 1
    • Primary completion date changed from estimate of May 2025 to Jun 20, 2025
    • Start date changed from estimate of Feb 2025 to Mar 20, 2025
    • Secondary endpoints revised (8)
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 2 words
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
8,786 trials monitored
See 412 trials at risk
5,087 trials monitored
See 222 trials at risk
3,874 trials monitored
See 152 trials at risk
and 1 more disease
This Pilot Study Large Application builds upon the results of our prior work to 1) Implement and pilot test a peer leader-facilitated 12-week dyadic intervention (Community Health among Asian Indian immigrants (CHAI) Dyad study) using a cluster randomization design, to decrease cardiovascular disease (CVD) risk among first generation AI immigrants; and 2) Assess the feasibility/acceptability of a full-scale intervention. Twenty marital dyads from the site randomly assigned as the intervention site will receive the 12- week peer leader-facilitated dyadic intervention, while 20 dyads from the site randomly assigned as the "usual care" control group site will receive a basic cardiovascular lifestyle modification program. Both groups will meet weekly (90 min. classes) for 12 weeks in a hybrid format (a combination of face to face and remote learning). The intervention is designed to address factors that we identified in our previous study as contributing to a syndemic of cardiovascular disease among AI immigrants including acculturation stress, family history and genetic risk, physical inactivity, as well as a high fat, high-carbohydrate, high-calorie diet.
Trial Details
NCT Number NCT06643806
Lead Sponsor Rutgers, The State University of New Jersey
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Conditions
(from sponsor)
Cardiovascular Diseases, Type 2 Diabetes Mellitus in Obese, Hyperlipidemias
Related terms Cardiovascular Diseases, Hyperlipidemias
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov