Prevention and Intervention of Overweight and Obesity in Preschool Children
NCT Number: NCT06562465
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overweight and Obesity
Interventions: PROCEDURE: dietary and exercise management|PROCEDURE: no dietary and exercise management
Sponsor: Chen Li
Collaborators: Children's Hospital of Chongqing Medical University|China Soong Ching Ling Foundation
Sex: ALL
Age: CHILD
Enrollment: 174
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-03-01
Completion Date: 2025-09-30
Locations: Growth,Development and Mental Health of Children and Adolescents Center, Chongqing, Chongqing, 400014, China|Children's Hospital of Chongqing Medical University, Chongqing, China

Summary:
Obesity is an important public health problem, which is directly related to the risk of childhood complications and the increase of incidence rate and mortality of adult complications. The consequences are more serious than malnutrition such as low weight. Since the 1980s, the obesity rate among children in China has gradually increased. Currently, overweight and obesity are important health issues for children in rural and urban areas of China, with obesity rates in many large cities approaching or exceeding those in developed countries. The Report on Nutrition and Chronic Disease Status of Chinese Residents (2020) shows that the overweight and obesity rate among children aged 6-17 in China has approached 20%, with 10% of children under 6 years old. The imbalance between energy intake and expenditure is the direct cause of individual overweight and obesity. The 2021 "Healthy Children Action Plan (2021-2025)" explicitly requires the implementation of early screening, early diagnosis, and early treatment prevention and control strategies for risk factors such as obesity that seriously endanger children's health, reducing disease burden, promoting children's health, emphasizing the principle of prevention first and combining prevention and treatment. Given the current status of children's nutrition and health in China, it is an urgent need to establish a standardized and regulated monitoring and management system for obesity and overweight in preschool children, as well as service standards, for the development of children's health. This project aims to establish a complete prevention, improvement, and intervention promotion plan for obesity and overweight in preschool children, as well as a comprehensive monitoring and management system that combines medicine, education, home, and community. It will strengthen children's nutrition feeding and exercise guidance, reduce sedentary time, promote food and movement balance, and prevent and reduce childhood overweight and obesity. Provide children with comprehensive, full process, and warm children's healthcare clothing, and provide small-scale policy research references for the implementation of support systems for children's nutrition improvement projects.

Primary Outcome Measures: BMI, Changes in BMI between the experimental group and intervention group at the beginning and end of the project, 3-4 months
Secondary Outcome Measures: Body composition--Fat (%), Changes in Body composition including Fat (%) between the experimental group and intervention group at the beginning and end of the project., 3-4 months|Body composition--Body fat index (BFMI), Changes in Body composition including Body fat index (BFMI) between the experimental group and intervention group at the beginning and end of the project., 3-4 months|Body composition--Fat-free mass index (FFMI), Changes in Body composition including Fat-free mass index (FFMI) between the experimental group and intervention group at the beginning and end of the project., 3-4 months
Other Outcome Measures: questionnaire investigation, Changes in questionnaire investigation（involving diet, exercise, and obesity awareness） between the experimental group and intervention group at the beginning and end of the project, 3-4 months|Blood indicators--ALT, Changes in blood indicators including glutamic-pyruvic transaminase (ALT) between the experimental group and intervention group at the beginning and end of the of the project., 3-4 months|Blood indicators--AST, Changes in blood indicators including glutamic-oxaloacetic transaminase(AST) between the experimental group and intervention group at the beginning and end of the of the project., 3-4 months|Blood indicators--creatinine, Changes in blood indicators including creatinine between the experimental group and intervention group at the beginning and end of the of the project., 3-4 months|Blood indicators--uric acid, Changes in blood indicators including uric acid between the experimental group and intervention group at the beginning and end of the of the project., 3-4 months|Blood indicators--urea, Changes in blood indicators including urea between the experimental group and intervention group at the beginning and end of the of the project., 3-4 months|Blood indicators--blood sugar, Changes in blood indicators including blood sugar between the experimental group and intervention group at the beginning and end of the of the project., 3-4 months|Blood indicators--triglyceride, Changes in blood indicators including triglyceride between the experimental group and intervention group at the beginning and end of the of the project., 3-4 months|Blood indicators--cholesterol, Changes in blood indicators including cholesterol between the experimental group and intervention group at the beginning and end of the of the project., 3-4 months|Blood indicators--high-density, Changes in blood indicators including high-density lipoprotein between the experimental group and intervention group at the beginning and end of the of the project., 3-4 months|Blood indicators--low density lipoprotein, Changes in blood indicators including low density lipoprotein between the experimental group and intervention group at the beginning and end of the of the project., 3-4 months|Blood indicators--VD, Changes in blood indicators including VD between the experimental group and intervention group at the beginning and end of the of the project., 3-4 months|Blood indicators--VA, cators including VA between the experimental group and intervention group, 3-4 months|Blood indicators--ferritin, cators including ferritin between the experimental group and intervention group, 3-4 months