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Childhood Obesity PreventionNCT07117149

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

A study testing multicomponent, tiered intervention in people with Childhood Obesity Prevention, run by Peking University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 4 to 6 years
Conditions the study is for
Childhood Obesity Prevention
What is being tested?
multicomponent, tiered intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
980 participants
Where
1 siteChina
Study dates
2 Oct 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Maternal and Child Health, School of Public Health

    Beijing, Beijing Municipality, 100191

Other trials in China

About this study

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

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.

Read the 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.

Being tested
multicomponent, tiered intervention
Keywords
Prevention, Intervention, Obesity, Children, Preschool
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multicomponent, tiered interventionBehavioural

    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.

Study groups in NCT07117149
Study groupRoleWhat they receive
multicomponent interventionExperimentalThis 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.
Receives: Behavioral: multicomponent, tiered intervention
usual-care controlNo interventionIn 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at end of the 9-month intervention

Secondary outcomes (11)

  1. 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.

    Measured: at 21-month follow-up

  2. Body Mass Index (BMI)

    BMI is calculated from measured height and weight.

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

  3. 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.

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

  4. waist-to-Height Ratio, WHtR

    Calculated by dividing waist circumference by height, used as an indicator of fat distribution and risk for metabolic complications.

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

  5. Systolic and Diastolic Blood Pressures

    Blood pressure is measured using an electronic sphygmomanometer with the child seated after resting, to assess cardiovascular health.

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

  6. Body Composition

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

    Measured: at the end of the 9-month intervention

  7. 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.

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

  8. Children's Eating Behaviors

    Assessed using the Children's Eating Behavior Questionnaire (CEBQ), measuring dimensions such as food responsiveness, satiety responsiveness, and emotional eating.

    Measured: at the end of the 9-month intervention

  9. 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.

    Measured: at the end of the 9-month intervention

  10. 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.

    Measured: at the end of the 9-month intervention

  11. 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.

    Measured: at the end of the 9-month intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start2 Oct 2025
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
980 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07117149
Sponsor's protocol ID
N0.2025-042
Status last verified
Sep 2026
First submitted
1 Aug 2025
Last updated
16 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Zhang L, Yan S, Yin C, Zhang Y, Liu H, Gao M, Zhang Z, Duan X, Wang H, Li Y. Protocol for a digital health-assisted cluster randomised controlled trial to prevent obesity in preschool children in Jinan, China. BMJ Open. 2026 Jul 13;16(7):e115136. doi: 10.1136/bmjopen-2025-115136.

    PubMed 42442808

Questions about this trial

What is this clinical trial studying?

A study testing multicomponent, tiered intervention in people with Childhood Obesity Prevention, run by Peking University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

children's BMI-Z change (time frame: at end of the 9-month intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07117149, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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