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

NCT ID: NCT07117149

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 882 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-02
• Study Completion Date: 2027-06-30

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.

Detailed Description

In the past four decades, the number of children and adolescents with obesity worldwide has increased tenfold, making childhood overweight and obesity one of the most pressing public health issues. In China, the prevalence of overweight and obesity among children under six years old in China has reached 10.4%.

Children with obesity are more likely to develop health problems than their normal-weight peers. The health impacts of childhood obesity often persist into adulthood, significantly increasing the risk of cardiovascular diseases, endocrine and respiratory disorders, cancers, and other chronic conditions. Therefore, the prevention and management of childhood obesity are critical for promoting both immediate and long-term health.

However, current intervention strategies often face challenges such as inconsistent outcomes, poor adherence, and a lack of theoretical foundation. There is a pressing need to develop more effective, scalable, and sustainable approaches.

To address this gap, we propose an intervention(PeKing University Smart Monitoring And Responsive Technology for early childhood health, PKU-SMART), a cluster-randomized preventive trial targeting preschool children. This study will develop and evaluate an innovative, digital health-supported, multi-sector, tiered intervention system aimed at improving preschoolers' health behaviors, reducing obesity prevalence, and supporting long-term weight management.

Conditions

Childhood Obesity Prevention

Study Design

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

Study Groups

multicomponent intervention

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.

Group Type: EXPERIMENTAL

multicomponent, tiered intervention

Intervention Type: 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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

multicomponent, tiered intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

Exclusion Criteria

• 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.

• 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.

• 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

Other Identifiers

N0.2025-042

Identifier Type: -

Identifier Source: org_study_id