Childhood Obesity Prevention
Conditions
Keywords
Prevention, Intervention, Obesity, Children, Preschool
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.
Interventions
BEHAVIORALmulticomponent, tiered intervention
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.
Sponsors
Peking University
Shandong Maternal and Child Health Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Randomization will be performed after the baseline survey. The assessors measuring childrens' health indicators will be blinded at follow-up phases.
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHaijun Wang, PhD
Peking University
Outcome results
None listed