Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents

StatusTerminated
PhaseNot applicable
Started

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Record History

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  1. Trial terminated Sponsor's reason: The study was terminated early after the study funder issued a Notice of Non-Award, resulting in loss of funding to continue study activities.
    • Final enrollment: 40 participants (planned 200)
    • Primary completion date changed from estimate of Jun 2027 to Aug 31, 2026
    • Site details revised at 2 of 2 sites
    v4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Primary and study completion dates pushed to Jun 2027
    • Start date changed from estimate of Jun 2024 to Feb 27, 2025
    • Study sites: 0 to 2
    • Eligibility criteria revised
    • Collaborators reordered
  3. Lead sponsor: Hunter College of City University of New York to Tufts Universityv2 Show 5 more changesShow less
    • Start date: Mar 2024 to Jun 2024
    • Study completion date: Jun 2025 to Aug 2026
    • Study description shortened, about 20 words
    • Collaborators: 5 to 6
    • Eligibility criteria expanded, about 1 word
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Tufts University
37 trials monitored
See 1 trial at risk
Obesity
3,909 trials monitored
See 165 trials at risk
Using a two-group randomized study design, this study aims to evaluate the effectiveness of the adapted family-centered mHealth tool on child BMI z-score (primary outcome), child dietary behaviors, and parental feeding practices, from baseline to 12-month follow-up, among 200 child-parent dyads. It is hypothesized that children in the experimental group will demonstrate larger BMI-z score improvements between baseline and 12-month follow-up compared to children in the comparison group.
Trial Details
NCT Number NCT05935592
Lead Sponsor Tufts University
Collaborators: Children's Aid, New York City, Washington University School of Medicine, Agency for Healthcare Research and Quality (AHRQ), Hunter College of City University of New York, City University of New York, School of Public Health, University of Massachusetts, Amherst
Conditions
(from sponsor)		 Obesity, Childhood
Related terms Pediatric Obesity
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov