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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Family engaged, enhanced Diet intervention
BehavioralThe family component includes health education via books, lectures, and short videos, parenting skills training, regular monitoring of child growth, and behavior goal setting through the mobile health platform. Motivational interviewing via telephone provides tailored behavioral support. Kindergartens assist in health education, supervise dietary intake and physical activity, monitor children's growth monthly, and maintain communication with families. Hospitals provide targeted health counseling and facilitate clinic access as needed. The mobile health platform integrates modules for health education, smart growth curve tracking, behavior goal management, and home-school-hospital collaboration.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: multicomponent interventionExperimental treatment 1 intervention
Group B: usual-care controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
children's BMI-Z change
Calculated based on height and weight using WHO standards. The primary outcome is the difference between two arms in the change of children's BMI-Z scores from baseline to the end of the intervention.
Time frame
at end of the 9-month interventionSecondary outcomes
1
children's BMI-Z change
Calculated based on height and weight using WHO standards. The primary outcome is the difference between two arms in the change of children's BMI-Z scores from baseline to follow-up.
Time frame
at 21-month follow-up.2
Body Mass Index (BMI)
BMI is calculated from measured height and weight.
Time frame
at the end of the 9-month intervention; at 21-month follow-up.3
Waist Circumference
Waist circumference is measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest to evaluate central adiposity.
Time frame
at the end of the 9-month intervention; at 21-month follow-up4
waist-to-Height Ratio, WHtR
Calculated by dividing waist circumference by height, used as an indicator of fat distribution and risk for metabolic complications.
Time frame
at the end of the 9-month intervention; at 21-month follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University
Lead sponsor
Shandong Maternal and Child Health Hospital
Collaborator
Source ClinicalTrials.gov
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