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Weight Management Program for Obese Preschool Children

StatusTerminated
PhaseNot applicable
Started
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Record History

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  1. Stopped Trial status changed: Not Yet Recruiting → Terminated Sponsor's reason: Study terminated prematurely due to poor accrual. The actual number of eligible children recruited from kindergartens was far lower than expected, making the study unfeasible. Show 7 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Final enrollment: 25 participants (planned 200)
    • Primary completion date changed from estimate of Jun 30, 2026 to Nov 30, 2025
    • Start date changed from estimate of Sep 15, 2025 to Oct 1, 2025
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 8 of 13 entries
    • Site contact updated
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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The PKU-FeeD trial is a cluster-randomized controlled trial conducted in Jinan, Shandong Province, China. This study aims to: 1) Develop and evaluate a digital health-assisted, multidisciplinary intervention for preschool children with obesity, assessing its effectiveness and cost-effectiveness. 2) Investigate how lifestyle-based interventions influence the composition and function of the gut microbiota in obese preschoolers, and elucidate the mechanisms by which these interventions may modulate gut microbiota to affect obesity-related metabolic phenotypes.
Trial Details
NCT Number NCT07126210
Lead Sponsor Peking University
Collaborators: Shandong Maternal and Child Health Hospital
Conditions
(from sponsor)
Childhood Obesity
Related terms Obesity, Pediatric Obesity
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov