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