Clinical Trial

Weight Management Program for Obese Preschool Children

Not Yet Recruiting
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Record status
This record was last updated August 17, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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 Childhood Obesity
Enrollment 200 participants
Start Date 2025-09-15
Primary Completion 2026-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-17