Clinical trial
Weight Management Program for Obese Preschool Children
Opening soon · Not applicable · 1 countries · Registry ID NCT07126210
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
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.
Primary outcomes
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.
Study locations
1 locations were listed when this page was built. The first 40 are shown.