Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07117149

Active, not recruitingNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age4 Years to 6 Years
SexAll
Healthy volunteersNot accepted
ConditionChildhood Obesity Prevention

Full registry 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.

Treatments and study arms

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.

Primary outcomes

children's BMI-Z changeat 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Department of Maternal and Child Health, School of Public Health🇨🇳 Beijing, Beijing Municipality, China