Weight Management Program for Obese Preschool Children

NCT07126210 | Not Yet Recruiting

• 1 other identifier: IRB00001052-25071
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Obesity

Keywords

Obesity; Intervention; Preschool; Management; Children

Outcome Measures

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.

  at end of the 9-month intervention

Secondary Outcomes (13)

• children's BMI-Z change

  at 21-month follow-up.

• Body Mass Index (BMI)

  at the end of the 9-month intervention; at 21-month follow-up.

• Waist Circumference

  at the end of the 9-month intervention; at 21-month follow-up

• waist-to-Height Ratio, WHtR

  at the end of the 9-month intervention; at 21-month follow-up.

• Systolic and Diastolic Blood Pressures

  at the end of the 9-month intervention; at 21-month follow-up.

Study Arms (2)

multicomponent intervention

EXPERIMENTAL

This study adopts a multicomponent intervention based on the "3 Less, 2 More, 1 Team" approach-Less fried/fatty foods, less sugar, less overeating; More colorful foods, more physical activity; and One team (family working together to raise a healthy child). The intervention is family-centered, supported by kindergartens and hospitals, with digital health technology.

Behavioral: Family engaged, enhanced Diet intervention

usual-care control

NO INTERVENTION

In the control group, participating preschools will receive no intervention during the study period and will continue their routine educational and management practices without modification. After the study is fully completed, control group preschools will receive access to all intervention materials and health education resources developed for this project.

Interventions

Family engaged, enhanced Diet intervention BEHAVIORAL

The 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.

multicomponent intervention

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Shandong Maternal and Child Health Hospital: collaborator

Study Sites (1)

Department of Maternal and Child Health, School of Public Health

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Haijun Wang, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiyu Yan, PhD

CONTACT

+8618888923314; yan_sy@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed after the baseline survey. The assessors measuring childrens' health indicators will be blinded at follow-up phases.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Department of Maternal and Child Health, School of Public Health, Peking University

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 17, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)