Life sciences · Interventional Study
ClinicalTrials.gov · September 16, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07126210). This is a study registration, not published results. Lead sponsor: Peking University. Recruitment status: TERMINATED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 25 participants (ACTUAL). Conditions: Childhood Obesity. Interventions: BEHAVIORAL: Family engaged, enhanced Diet intervention. Primary outcome measures: children's BMI-Z change , at end of the 9-month intervention. Brief 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.