Weight Management Program for Obese Preschool Children

NCT ID: NCT07126210

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-06-30

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.

Detailed Description

Childhood obesity has become a global public health challenge, and early prevention and management are crucial to curbing its epidemic. However, compared to school-aged children, evidence on effective obesity interventions for preschoolers remains limited and inconsistent. While preventive approaches may have broader population-level implications, targeted management interventions may be more cost-effective in settings with lower obesity prevalence but rising trends, providing foundational evidence for future preventive strategies.

The gut microbiota plays a key role in host energy metabolism and metabolic homeostasis, and its dysbiosis is strongly linked to obesity. Diet and physical activity, as core components of lifestyle interventions, may significantly shape gut microbial ecology, potentially influencing host metabolism and obesity-related outcomes. However, due to challenges in sample collection, existing studies on gut microbiota in children are scarce, with small sample sizes, and few intervention studies have established causal relationships. The interplay between healthy lifestyle interventions, gut microbiota, and childhood obesity remains understudied, and the underlying mechanisms require further exploration. Thus, this trial seeks to: 1) determine effectiveness of a digital health-supported, comprehensive intervention for preschool obesity management. 2) Elucidate causal relationships between dietary behaviors, gut microbiota, and obesity in preschoolers.

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

multicomponent intervention

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.

Group Type: EXPERIMENTAL

Family engaged, enhanced Diet intervention

Intervention Type: 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.

usual-care control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Maternal and Child Health Hospital

UNKNOWN

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Hai-Jun Wang

Professor in Department of Maternal and Child Health, School of Public Health, Peking University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haijun Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University

Locations

Department of Maternal and Child Health, School of Public Health

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Shiyu Yan, PhD

Role: CONTACT

yan_sy@bjmu.edu.cn

+8618888923314

Facility Contacts

Shiyu Yan, PhD

Role: primary

yan_sy@bjmu.edu.cn

+8618888923314

Other Identifiers

IRB00001052-25071

Identifier Type: -

Identifier Source: org_study_id