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NCT07117149Active, not recruiting

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

Peking University Smart Monitoring and Responsive Technology for Early Childhood Health (PKU-SMART)

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
980 (estimated)
First submitted
1 Aug 2025
Start date
2 Oct 2025
Primary completion date
30 Jun 2026
Lead sponsor
Peking University
Diseases
Obesity
NCT number
NCT07117149

What you commit to

  • Study type: Interventional
  • Planned participants: 980
  • From 2 Oct 2025 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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.

Age in the registry: 4 years to 6 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Maternal and Child Health, School of Public Health
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.