Early-Life Strategies for Preventing Obesity in Preschool-aged Children (NCT07117149) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early-Life Strategies for Preventing Obesity in Preschool-aged Children
China980 participantsStarted 2025-10-02
Plain-language 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.
Who can participate
Age range4 Years – 6 Years
SexALL
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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.
* Chi…