An interventional study of multicomponent, tiered intervention in Childhood Obesity Prevention, sponsored by Peking University. Active, not recruiting at 1 site in China. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Peking University · Not applicable, Interventional, and Prevention
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 980 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.
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Kindergarten-Level Inclusion Criteria:
Kindergarten-Level Exclusion Criteria:
Child-Level Inclusion Criteria:
Child-Level Exclusion Criteria:
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.
Behavioral: multicomponent, tiered intervention
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.
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.
children's BMI-Z change
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.
Time frame: at end of the 9-month intervention
children's BMI-Z change
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 follow-up.
Time frame: at 21-month follow-up
Body Mass Index (BMI)
BMI is calculated from measured height and weight.
Time frame: at the end of the 9-month intervention; at 21-month follow-up.
Waist Circumference
Waist circumference is measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest to evaluate central adiposity.
Time frame: at the end of the 9-month intervention; at 21-month follow-up.
waist-to-Height Ratio, WHtR
Calculated by dividing waist circumference by height, used as an indicator of fat distribution and risk for metabolic complications.
Time frame: at the end of the 9-month intervention; at 21-month follow-up.
Systolic and Diastolic Blood Pressures
Blood pressure is measured using an electronic sphygmomanometer with the child seated after resting, to assess cardiovascular health.
Time frame: at the end of the 9-month intervention; at 21-month follow-up.
Body Composition
Body fat percentage is assessed using a bioelectrical impedance analyzer (MC-780A, TANITA, Tokyo, Japan).
Time frame: at the end of the 9-month intervention
Prevalence and Incidence of Overweight/Obesity
The proportion of children classified as overweight or obese according to WHO and Chinese standards, including newly identified cases at follow-up.
Time frame: at the end of the 9-month intervention; at 21-month follow-up.
Children's Eating Behaviors
Assessed using the Children's Eating Behavior Questionnaire (CEBQ), measuring dimensions such as food responsiveness, satiety responsiveness, and emotional eating.
Time frame: at the end of the 9-month intervention
Parental Feeding Practices (CPCFBS)
Measured using the Chinese Preschooler's Caregivers Feeding Behavior Scale (CPCFBS), evaluating dimensions such as monitoring, pressure to eat, and food restriction.
Time frame: at the end of the 9-month intervention
Time Spent in Physical Activity
Evaluated using the Children's Leisure Activities Study Survey (CLASS), assessing the amount and type of physical activity and sedentary behavior, including screen time.
Time frame: at the end of the 9-month intervention
Time Spent in Sedentary Behavior
Evaluated using the Children's Leisure Activities Study Survey (CLASS), assessing the amount and type of physical activity and sedentary behavior, including screen time.
Time frame: at the end of the 9-month intervention
Plan to share: No — Individual participant data (IPD) will not be shared publicly due to ethical considerations. In accordance with the study's ethical approval and informed consent procedures, the data contain potentially sensitive personal health information and are protected to ensure participant confidentiality and privacy. Data access is therefore restricted to authorized research personnel only and cannot be made publicly available.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Peking University