NCT07126210Terminated
Weight Management Program for Obese Preschool Children
Peking University-Family Engaged, Enhanced Diet, for Kids (PKU-FeeD)
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 1 Aug 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Peking University
- Diseases
- Obesity
- NCT number
- NCT07126210
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 with pathological eating disorders or medical conditions that limit physical activity.
Other
- Children following special diets (e.g., vegetarians).
Who the study is looking for
- 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.
Age in the registry: 4 years to 6 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Maternal and Child Health, School of Public Health | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.