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

Not Applicable

Not yet recruiting

• Conditions: Childhood Obesity Prevention

• Registration Number: NCT07117149
• Lead Sponsor: Peking University

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-10
• Last Update Submitted: 2025-08-10
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Study Start: 2025-09-15
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Time Spent in Sedentary Behavior	at the end of the 9-month intervention	Evaluated using the Children's Leisure Activities Study Survey (CLASS), assessing the amount and type of physical activity and sedentary behavior, including screen time.
children's BMI-Z change	at 21-month follow-up	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.
Prevalence and Incidence of Overweight/Obesity	at the end of the 9-month intervention; at 21-month follow-up.	The proportion of children classified as overweight or obese according to WHO and Chinese standards, including newly identified cases at follow-up.
Children's Eating Behaviors	at the end of the 9-month intervention	Assessed using the Children's Eating Behavior Questionnaire (CEBQ), measuring dimensions such as food responsiveness, satiety responsiveness, and emotional eating.
Parental Feeding Practices (CPCFBS)	at the end of the 9-month intervention	Measured using the Chinese Preschooler's Caregivers Feeding Behavior Scale (CPCFBS), evaluating dimensions such as monitoring, pressure to eat, and food restriction.
Body Mass Index (BMI)	at the end of the 9-month intervention; at 21-month follow-up.	BMI is calculated from measured height and weight.
waist-to-Height Ratio, WHtR	at the end of the 9-month intervention; at 21-month follow-up.	Calculated by dividing waist circumference by height, used as an indicator of fat distribution and risk for metabolic complications.
Systolic and Diastolic Blood Pressures	at the end of the 9-month intervention; at 21-month follow-up.	Blood pressure is measured using an electronic sphygmomanometer with the child seated after resting, to assess cardiovascular health.
Time Spent in Physical Activity	at the end of the 9-month intervention	Evaluated using the Children's Leisure Activities Study Survey (CLASS), assessing the amount and type of physical activity and sedentary behavior, including screen time.
Waist Circumference	at the end of the 9-month intervention; at 21-month follow-up.	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.
Body Composition	at the end of the 9-month intervention	Body fat percentage is assessed using a bioelectrical impedance analyzer (MC-780A, TANITA, Tokyo, Japan).

Trial Locations

Locations (1)

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