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NOT YET RECRUITING
NCT07126210
NA

Weight Management Program for Obese Preschool Children

Sponsor: Peking University

View on ClinicalTrials.gov

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.

Official title: Peking University-Family Engaged, Enhanced Diet, for Kids (PKU-FeeD)

Key Details

Gender

All

Age Range

4 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-09-15

Completion Date

2027-06-30

Last Updated

2025-08-17

Healthy Volunteers

No

Interventions

BEHAVIORAL

Family engaged, enhanced Diet intervention

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.

Locations (1)

Department of Maternal and Child Health, School of Public Health

Beijing, Beijing Municipality, China