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Terminated NCT07126210

Weight Management Program for Obese Preschool Children

Conditions: Childhood Obesity

Sex: All
Ages: 4 Years – 6 Years
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Peking University

Location: Department of Maternal and Child Health, School of Public Health Beijing Beijing Municipality

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.

Eligibility Criteria

Inclusion Criteria: * The child's primary caregivers can proficiently use smart phones. * Child is expected to remain in the same kindergarten for at least one year. * No use of antibiotics or probiotic supplements, no acute stress events (e.g., trauma or severe infection), gastrointestinal symptoms (e.g., abdominal pain, constipation, diarrhea), or vaccinations within the 3 months prior to stool sample collection. * Parents voluntarily agree to participate in the study and provide written informed consent. Exclusion Criteria: * Obesity caused by genetic factors, diseases (e.g., endocrine disorders, central nervous system damage), or medication use. * History of major organ diseases, including cardiovascular, pulmonary, hepatic, or renal conditions (e.g., heart disease, hypertension, asthma). * Children following special diets (e.g., vegetarians). * Children with pathological eating disorders or medical conditions that limit physical activity.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07126210). StuddyBuddy aggregates publicly available trial information.