Clinical trial

Weight Management Program for Obese Preschool Children

Opening soon · Not applicable · 1 countries · Registry ID NCT07126210

Opening soonNot applicableInterventional

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age4 Years to 6 Years
SexAll
Healthy volunteersNot accepted
ConditionChildhood Obesity

Full registry criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Treatments and study arms

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.

Primary outcomes

children's BMI-Z changeat end of the 9-month intervention

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.

Department of Maternal and Child Health, School of Public Health🇨🇳 Beijing, Beijing Municipality, China
Shiyu Yan, PhDContact