Weight Management Program for Obese Preschool Children
ConditionChildhood Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorPeking University
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Family engaged, enhanced Diet intervention
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peking University
Lead sponsor
Shandong Maternal and Child Health Hospital
Collaborator
Source ClinicalTrials.gov