Early-Life Strategies for Preventing Obesity in Preschool-aged Children

NCT07117149 | Active Not Recruiting

• 1 other identifier: N0.2025-042
• Study Type: interventional
• Target: 980
• Locations: 1 country
• Sites: 1

Brief Summary

The PKU-SMART is a cluster randomized controlled trial conducted in Jinan, Shandong Province, China. This preventive intervention study aims to develop and evaluate a comprehensive obesity intervention framework for preschool children that integrates digital health technologies, multi-sectoral collaboration, and tiered management strategies. The effectiveness and cost-effectiveness of this approach will be assessed.

Conditions

Childhood Obesity Prevention

Keywords

Prevention; Intervention; Obesity; Children; Preschool

Outcome Measures

Primary Outcomes (1)

• children's BMI-Z change

  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.

  at end of the 9-month intervention

Secondary Outcomes (11)

• children's BMI-Z change

  at 21-month follow-up

• Body Mass Index (BMI)

  at the end of the 9-month intervention; at 21-month follow-up.

• Waist Circumference

  at the end of the 9-month intervention; at 21-month follow-up.

• waist-to-Height Ratio, WHtR

  at the end of the 9-month intervention; at 21-month follow-up.

• Systolic and Diastolic Blood Pressures

  at the end of the 9-month intervention; at 21-month follow-up.

Study Arms (2)

multicomponent intervention

EXPERIMENTAL

This intervention adopts a multi-component, multi-setting approach. Interventions are delivered across kindergartens, families, and healthcare systems, with varying intensity and personalization. Kindergartens serve as the primary implementation site. Trained kindergarten teachers deliver structured health education sessions and conduct regular anthropometric monitoring. Parents play a crucial role in supporting and sustaining children's healthy behaviors. Family-focused components include both health education and behavior change techniques, delivered through offline meetings and the digital health platform. The intervention is supported by a digital health platform ("PKU-SMART Health Platform") where health professionals provide consultation and tailored advice to families. This component aims to reinforce health literacy and access to expert resources.

Behavioral: multicomponent, tiered intervention

usual-care control

NO INTERVENTION

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 have access to all intervention materials and health education resources developed for this project.

Interventions

multicomponent, tiered intervention BEHAVIORAL

Kindergarten: Train teachers and integrate healthy weight management into kindergarten health policies; deliver health education sessions for children; monitor extra dietary intake and physical activity; conduct monthly height and weight measurements. Family: Provide multi-format health education (lectures, short videos, articles) to communicate core intervention messages; set health behavior goals and deliver personalized feedback; conduct motivational interviewing in offline parent meetings or by phone. Hospital: Offer professional health guidance and medical services. PKU-SMART online platform: Health Education Module; Growth Monitoring Module; Health Behavior Module; Home-Kindergarden Partnership Module.

multicomponent intervention

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The kindergarten's principal or headmaster consents to participate in the study, and the school demonstrates a high level of cooperation. Required personnel, such as a school health care provider, are available.
• The total number of children in the middle and senior classes (approximately ages 4-6) exceeds 100.
• Teachers and parents of the selected classes demonstrate good compliance and willingness to cooperate with project implementation.

You may not qualify if:

• Special kindergartens, such as part-time institutions or schools for children with special needs.
• Kindergartens that have participated or plan to participate in other obesity-related intervention projects within the past year or upcoming year.
• Kindergartens scheduled for closure or relocation within the next two years.
• The child's primary caregivers can proficiently use smart phones.
• The child is expected to remain enrolled in the same kindergarten for at least one year.
• Parents or legal guardians provide written informed consent for participation.
• Obesity caused by genetic disorders, endocrine diseases, central nervous system damage, or long-term medication use.
• History of significant diseases affecting major organs such as the heart, lungs, liver, or kidneys (e.g., congenital heart disease, hypertension, asthma).
• Children on special diets, including vegetarianism.
• Children diagnosed with pathological eating disorders or conditions that impair physical activity.

Sponsors & Collaborators

• Peking University: lead
• Shandong Maternal and Child Health Hospital: collaborator

Study Sites (1)

Department of Maternal and Child Health, School of Public Health

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Haijun Wang, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed after the baseline survey. The assessors measuring childrens' health indicators will be blinded at follow-up phases.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Department of Maternal and Child Health, School of Public Health, Peking University

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 12, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)