Weight Management Program for Obese Preschool Children

Peking University

Status: Not yet enrolling

Conditions: Childhood Obesity

Treatments: Behavioral: Family engaged, enhanced Diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07126210

IRB00001052-25071

Details and patient eligibility

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

multicomponent intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Family engaged, enhanced Diet intervention

usual-care control

No Intervention group

Description:

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.