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NCT Number: NCT07117149

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Maternal and Child Health, School of Public Health

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. children's BMI-Z change

    Time frame: 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 outcomes

  1. children's BMI-Z change

    Time frame: 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.

  2. Body Mass Index (BMI)

    Time frame: at the end of the 9-month intervention; at 21-month follow-up.

    BMI is calculated from measured height and weight.

  3. Waist Circumference

    Time frame: 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.

  4. waist-to-Height Ratio, WHtR

    Time frame: 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.

  5. Systolic and Diastolic Blood Pressures

    Time frame: 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.

  6. Body Composition

    Time frame: at the end of the 9-month intervention

    Body fat percentage is assessed using a bioelectrical impedance analyzer (MC-780A, TANITA, Tokyo, Japan).

  7. Prevalence and Incidence of Overweight/Obesity

    Time frame: 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.

  8. Children's Eating Behaviors

    Time frame: 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.

  9. Parental Feeding Practices (CPCFBS)

    Time frame: 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.

  10. Time Spent in Physical Activity

    Time frame: 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.

  11. Time Spent in Sedentary Behavior

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • Shandong Maternal and Child Health Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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