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A Multifaceted Intervention to Reduce Obesity Among Preschool Children: Study Protocol for a Randomized Controlled Trial in Suzhou City

NCT07361211 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-03-24
Last updated
2026-07-27

Condition(s) studied

ChildrenObesity & OverweightIntervention

Investigational drug(s) / intervention(s)

Student-focused activitiesActivities towards parents (providing a supportive family environment)Activities towards schools (providing a supportive school environment)Activities towards community (providing a supportive community environment)Policy

Student-focused activities: 1. Pre-school children will receive health education lessons, delivered by a trained teacher every month, which consists of 10 lessons. The core content of the program is to recognize obesity and prevent it (including healthy diet, regular exercise, reducing snack intake, and getting sufficient sleep). 2. Physical Education teachers will increase the amount or duration of exercise (mainly aerobic exercise) for more than 60 minutes in accordance with expert advice. Three to four specialized physical education classes will be held each month to encourage children to participate in more sports activities. When the weather is inclement, teachers will guide children to do relevant alternative activities to maintain their physical activities, e.g. ice skating in winter, indoor games in rainy days.

Activities towards parents (providing a supportive family environment): 1. Parents should rationalize their children's diet according to the "Dietary Guidelines on Childhood and Adolescent Obesity", have regular meals every day, try not to eat in restaurants, reduce the consumption of sugary carbonated beverages, increase the intake of vegetables and reduce the purchase of unhealthy snacks. 2. Parents should take their children to do some appropriate outdoor activities every day according to the "Physical Education and Sports Guidebook", and encourage them to engage in more games and communication with their peers. Limit children's screen time, including not watching TV during meals. 3. Parents of overweight and obese children will all join a move more club, and the teachers in the club will provide additional guidance and assistance regarding weight management.

Activities towards schools (providing a supportive school environment): 1. A professional dietitian will evaluate the meal pattern of each child based on a questionnaire, make recommendations, and help the cafeteria staff to adjust the school lunch and afternoon tea once a month. 2. Reward obese or overweight children whose BMI has dropped significantly by selecting little masters of weight management or little stars of weight control to encourage them. 3. School administrators need to post posters and wall posters on weight management outside the classroom, not set up vending machines for sugary drinks outside the classroom, and provide water fountains to encourage drinking more water. 4. Increase the number of sports facilities and playing fields, and organize fun sports activities every semester to attract children's interest. 5. Create a positive school climate and avoid stressors associated with a poor school climate such as bullying, personal safety, peer behavior and weight stereotyping.

Activities towards community (providing a supportive community environment): 1. Health education seminars are held twice a semester with the participation of teaching specialists, physical education teachers and parents. Professional knowledge and health manuals are provided, and after the seminars, the program professionals are added to the parents' group to facilitate communication. 2. Medical check-ups and assessments of children are conducted by professionals every six months, and medical assessments and guidance are provided. 3. Posters of health knowledge will be put up on community bulletin boards, the media will publicize healthy food, and official WeChat public account will publish two high-quality scientific articles each month, accompanied by animated videos and case studies, in line with the slogan 'Eat wisely, move wisely, prevent obesity.'. 4. The community need to provide sports facilities for both adults and children to facilitate leisure sports for parents and children after work to enhance parent-child bonding.

Policy: 1. Establish cross-sectoral collaboration, setting up a multi-departmental joint system of the Ministry of Education, the Health Planning Commission, and the General Administration of Market Supervision and Regulation, and jointly issuing the "Guidelines for Prevention and Control of Obesity in Preschool Children" to clarify the responsibilities of kindergartens, families, and communities. 2. Incorporate "child-friendly exercise space" into neighborhood renovation indicators, and require the addition of physical training facilities for young children. 3. Establish mandatory health standards, require kindergartens to ensure preschool children's activity levels and meals, and incorporate obesity prevention and control into kindergarten grade assessments

Study summary

This study aimed to develop a comprehensive, multi-faceted intervention program for weight control and systematically evaluated its effectiveness on indicators of adiposity.

Eligibility

Sex
ALL
Min age
3 Years
Max age
6 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Children were eligible for inclusion if they were between 3 and 6 years old and their guardians had been informed and provided consent to participate in the study. Exclusion Criteria: * Exclusion criteria included: a history of heart disease, hypertension, diabetes mellitus, asthma, viral hepatitis, or nephritis; obesity due to endocrine disease or medication; abnormal physical development or deformities; inability to participate in school sports; or recent weight loss due to vomiting or medication use within the past three months.

Primary outcome measure(s)

  • Healthy weight development — through study completion, an average of 1 year
    Child BMI, child BMI z-score, child body fat percentage Child BMI: Use the automatic height and weight measuring device to measure height and weight. The subject should wear light clothing and stand barefoot, facing away from the pillar and standing on the base plate of the height gauge with the trunk naturally straight and the head upright, looking straight ahead. Height is measured in centimeters, with a test error not exceeding 0.5 centimeters. Weight is measured in kilograms, with a test error not exceeding 0.1 kilograms. BMI will be calculated as weight (kg) divided by height squared (m²). Child BMI z-score: Use the WHO child growth standards, taking into account the child's gender and age. Child body fat percentage: Use the InBody 570 body composition analyzer to measure the body fat percentage of children. Use InBody wet wipes to wipe hands and feet, which helps to increase the conductivity of the current. Stand on the InBody to measure the body fat percentage.Unit: %

Trial sites (1)

FacilityCityRegionStatus
Weight Management and Tracking for Children in Suzhou City Suzhou Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07361211 on ClinicalTrials.gov ↗ ← All trials in China