NCT07361211

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,486 (actual)
• Sponsor: Soochow University · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The rising prevalence of obesity among preschool children has become a critical public health concern in Suzhou of China. Nevertheless, evidence-based, personalized, and multi-component intervention strategies tailored to overweight and obese children remain inadequately established in current practice. This is a cluster randomized controlled trial conducted among children in Suzhou City, Jiangsu Province. Children from junior and middle classes (aged 3 to 6) were recruited from six kindergartens. Three kindergartens were assigned to the intervention group and three to the control group. The one-year intervention includes health education, dietary guidance, and increased physical activity. The program takes a multi-level approach, engaging children, families, schools, communities, and society. Parental education and ongoing tracking of knowledge, attitudes, and practices are key components of the family-based intervention. Assessments will be conducted at 6 months, 12 months and subsequent follow-up periods after the baseline. The primary outcome will be the difference in body mass index (BMI) and body fat percentage between the two groups of children at the end of the intervention. This program will test the effectiveness of comprehensive multi-faceted interventions on children. The results of this study will provide scientific evidence for formulating effective intervention strategies for childhood overweight and obesity, and are also expected to offer crucial practical references for the formulation and improvement of treatment guidelines for childhood obesity in China.

Conditions

• Children
• Obesity & Overweight
• Intervention

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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

Timeline

• Start date: 2025-03-24
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: China