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

StatusTerminated
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  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 sitesv4 Show all 4 changesShow less
    • 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
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jun 2025 to Jun 2027 · Start date changed from estimate of Jun 2024 to Feb 27, 2025 · Study sites: 0 to 2 · 3 morev3 Show all 7 changesShow less
    • Primary completion date: Jun 2025 to Jun 2027
    • Start date changed from estimate of Jun 2024 to Feb 27, 2025
    • Study sites: 0 to 2
    • Completion date: Aug 2026 to Jun 2027
    • Eligibility criteria revised
    • Collaborators reordered

    See this version in full on ClinicalTrials.gov ↗

  3. Lead sponsor: Hunter College of City University of New York to Tufts University Start date: Mar 2024 to Jun 2024 · Completion date: Jun 2025 to Aug 2026 · Study description shortened, about 20 words · 2 morev2 Show all 6 changesShow less
    • Start date: Mar 2024 to Jun 2024
    • Completion date: Jun 2025 to Aug 2026
    • Study description shortened, about 20 words
    • Collaborators: 5 to 6
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Tufts University
37 trials monitored
See 1 trial at risk
Obesity
3,560 trials monitored
See 142 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 Obesity, Childhood
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov