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

Peking University

Status: Active, not recruiting

Conditions: Childhood Obesity Prevention

Treatments: Behavioral: multicomponent, tiered intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07117149

N0.2025-042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 882 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Kindergarten-Level 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.

Kindergarten-Level 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.

Child-Level Inclusion Criteria:

• 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.

Child-Level Exclusion Criteria:

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

882 participants in 2 patient groups

multicomponent intervention

Experimental group

Description:

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.

Treatment:

Behavioral: multicomponent, tiered 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 have access to all intervention materials and health education resources developed for this project.