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

Background The rising prevalence of obesity among preschool children has become a critical public health concern in Suzhou, China. Nevertheless, evidence-based, personalized, and multicomponent intervention strategies tailored to children with overweight or obesity remain inadequately established in current practice. Objective This study aims to investigate the prevalence and pathogenic factors of obesity among preschool children in Suzhou and to develop a comprehensive and multifaceted integrated intervention program. Through systematic assessment of its short-term effectiveness and long-term sustainability in improving obesity-related indicators and preventing overweight, it provides a scientific basis for obesity prevention and control. Methods This cluster randomized controlled trial is being conducted among children aged 3 to 6 years in Suzhou City, Jiangsu Province. Children from 3 kindergartens were randomly assigned to the intervention group and children from 3 other kindergartens were assigned to the control group. The 1-year intervention includes health education, dietary guidance, and increased physical activity, adopting a multilevel approach that engages children, families, schools, communities, and society. Children participate in health education and physical activity courses in the kindergarten, while parents receive educational materials online. Parental education and regular assessment of knowledge, attitudes, and practices are key components of the family-based intervention. Body measurements will be taken at baseline, 6 months, 12 months, and thereafter, alongside questionnaires for both parents and children to evaluate their own health behaviors. The primary outcome will be the difference in BMI, BMI z scores, and body fat percentage between the 2 groups of children at the end of the intervention. Results The study received ethical approval in March 2025. Baseline assessments were conducted from March to June 2025, followed by the initiation of the intervention, which will be completed by June 2026. Participants will then enter a noninterventional long-term follow-up until June 2032, with annual surveys conducted during this period. Conclusions This program will test the effectiveness of comprehensive multifaceted 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.