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.
Study 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.
Eligibility
Sex
ALL
Min age
4 Years
Max age
6 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
children's BMI-Z change — at end of the 9-month intervention 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.
Trial sites (1)
Facility
City
Region
Status
Department of Maternal and Child Health, School of Public Health
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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