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

NCT07361211 | Active Not Recruiting

• 1 other identifier: 86362525
• Study Type: interventional
• Target: 1,486
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intervention; Children; Obesity & Overweight

Keywords

Children; Obesity; Multifaceted intervention; Parents; Community - school - family - healthcare

Outcome Measures

Primary Outcomes (1)

• Healthy weight development

  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: %

  through study completion, an average of 1 year

Secondary Outcomes (9)

• Healthy weight development

  through study completion, an average of 1 year

• Child cardiovascular

  through study completion, an average of 1 year

• Child well-being

  through study completion, an average of 1 year

• Child eating habits

  through study completion, an average of 1 year

• Child physical activity

  through study completion, an average of 1 year

Study Arms (2)

the intervention group

EXPERIMENTAL

Based on the Social Ecological Model (SEM) and Social Cognitive Theory (SCT), this multi-component, school-based, and family-involved program adopts a "community-school-family-medical" integrated prevention model.The program implements targeted interventions at individual, family, school, community, and societal levels to address childhood obesity and influence preschool children's knowledge, attitudes, and behaviors. Interventions will also be carried out during holidays. Trained professionals will distribute health materials to children and organize a three-week check-in activity. During this period, children's daily habits-including diet (regular meals, adequate water intake, no sugary beverages), exercise (outdoor activities, sedentary time, screen time), and sleep patterns-will be recorded. The aim is to help children gradually develop healthy habits.

Behavioral: Student-focused activities; Behavioral: Activities towards parents (providing a supportive family environment); Behavioral: Activities towards schools (providing a supportive school environment); Behavioral: Activities towards community (providing a supportive community environment); Behavioral: Policy

Control

NO INTERVENTION

Interventions

Student-focused activities BEHAVIORAL

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.

the intervention group

Activities towards schools (providing a supportive school environment) BEHAVIORAL

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.

the intervention group

Activities towards community (providing a supportive community environment) BEHAVIORAL

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.

the intervention group

Policy BEHAVIORAL

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

the intervention group

Activities towards parents (providing a supportive family environment) BEHAVIORAL

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.

the intervention group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Soochow University: lead
• Suzhou Center for Disease Control and Prevention: collaborator

Study Sites (1)

Weight Management and Tracking for Children in Suzhou City

Suzhou, Jiangsu, 215123, China

Location

Related Publications (7)

• Sommer A, Twig G. The Impact of Childhood and Adolescent Obesity on Cardiovascular Risk in Adulthood: a Systematic Review. Curr Diab Rep. 2018 Aug 30;18(10):91. doi: 10.1007/s11892-018-1062-9.

  PMID: 30167798 BACKGROUND

• Skinner AC, Mayer ML, Flower K, Weinberger M. Health status and health care expenditures in a nationally representative sample: how do overweight and healthy-weight children compare? Pediatrics. 2008 Feb;121(2):e269-77. doi: 10.1542/peds.2007-0874. Epub 2008 Jan 14.

  PMID: 18195001 BACKGROUND

• Simmonds M, Llewellyn A, Owen CG, Woolacott N. Predicting adult obesity from childhood obesity: a systematic review and meta-analysis. Obes Rev. 2016 Feb;17(2):95-107. doi: 10.1111/obr.12334. Epub 2015 Dec 23.

  PMID: 26696565 BACKGROUND

• Perng W, Rifas-Shiman SL, Kramer MS, Haugaard LK, Oken E, Gillman MW, Belfort MB. Early Weight Gain, Linear Growth, and Mid-Childhood Blood Pressure: A Prospective Study in Project Viva. Hypertension. 2016 Feb;67(2):301-8. doi: 10.1161/HYPERTENSIONAHA.115.06635. Epub 2015 Dec 7.

  PMID: 26644238 BACKGROUND

• Ye F, Chen J, Hui Q, Liu D, Sun Q, Liu J, Zhang Q. Full title: prevalence and risk factors of overweight in Beijing infants basing generalized estimating equation: a longitudinal study. BMC Public Health. 2025 Feb 10;25(1):543. doi: 10.1186/s12889-025-21704-9.

  PMID: 39930450 BACKGROUND

• Global Nutrition Target Collaborators. Global, regional, and national progress towards the 2030 global nutrition targets and forecasts to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2025 Dec 21;404(10471):2543-2583. doi: 10.1016/S0140-6736(24)01821-X. Epub 2024 Dec 9.

  PMID: 39667386 BACKGROUND

• NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet. 2017 Dec 16;390(10113):2627-2642. doi: 10.1016/S0140-6736(17)32129-3. Epub 2017 Oct 10.

  PMID: 29029897 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Policy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 22, 2026
• Study Start: March 24, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

CN (1)