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Prevention and Intervention of Overweight and Obesity in Preschool Children

Research on Prevention and Intervention of Overweight and Obesity in Preschool Children

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06562465
Enrollment
174
Registered
2024-08-20
Start date
2024-03-01
Completion date
2025-09-30
Last updated
2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Diet management, sports management, overweight, obesity, preschool children

Brief 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.

Detailed description

1. Procedures. Step 1: Epidemiological survey: Conduct a health survey on preschool children in selected kindergartens to understand the prevalence and risk factors of overweight and obese children; Phase 2: Recruit overweight and obese children from kindergartens with a population of over 200 in Chongqing, and randomly divide them into an intervention group and a blank control group. Dietary and exercise management, combined with reward and support mechanism monitoring, were implemented for the intervention group, while the blank control group did not receive the aforementioned interventions. Measure the height, weight, BMI, questionnaire survey, blood indicators, etc. of the children before and after the intervention, and use them as evaluation indicators. 2. The sample size for comparing the means of the two groups is N=(Z α/2+Z β) 2 σ 2 (Q1-1+Q2-1)/δ 2. If the difference in BMI decrease between the two groups after intervention is 0.58, and if σ=1.2 and α is taken as 0.05 on both sides, the test power is 0.8, Q1=Q2=0.5,σ=1.2,δ=0.58,Z0.05/2=1.96,Zβ=0.842, Calculate N=(1.96+0.842) 2 \* 1.22 \* (0.5-1+0.5-1)/0.582 ≈ 69, taking into account the situation of loss to follow-up and refusal to follow up at 20%. The final required two groups of research subjects are 87, and a total of at least 174 research subjects will be included. 4\. Statistical analysis. SPSS 26.0 software was used for statistical analysis, and descriptive statistics were performed on general demographic data. Count data was expressed as n (%), and inter group comparisons of rates were performed using a 2-test. Continuous variables that followed a normal distribution were described as mean ± standard deviation (x ± s), and inter group comparisons were performed using t-test. All tests were two-sided, and the test level α was set to 0.05. Multivariate logistic regression analysis of the correlation between nutritional status and risk factors. Using rank sum test to compare the differences in various indicators before and after intervention in obese and overweight children. 5.Ethical matters and data protection. The patients participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee. Patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.

Interventions

PROCEDUREdietary and exercise management

Dietary and exercise management: dietary management by providing tailored recipes, health education lectures, science competitions, etc;exercise management:develop weekly and monthly exercise plans for children of different ages, and have physical education teachers lead them in exercising.

PROCEDUREno dietary and exercise management

NO dietary and exercise management:do not implement dietary and exercise management related to the experimental group

Sponsors

Children's Hospital of Chongqing Medical University
CollaboratorOTHER
China Soong Ching Ling Foundation
CollaboratorOTHER
Chen Li
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Recruit at least 174 overweight and obese children from kindergartens with a population of 200 or more in Chongqing, and recruit them in the order of screening and informed consent until they are fully recruited. Divided into intervention group and blank control group based on kindergarten.

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

overweight or obese Children Currently, there are no projects related to overweight and obesity management (such as weight loss management, etc.) Parents and children are willing to accept dietary and exercise management for a period of 4 months Willing to measure height, weight, BMI, blood pressure, body composition, questionnaire survey (exercise, diet, etc.) and other items before intervention and 1 month, 2 months, 3 months, and 4 months after intervention (a total of 5 times) Willing to undergo blood tests before and 4 months after intervention (2 times in total); The questionnaire information is filled in accurately and meets the questionnaire quality control standards

Exclusion criteria

Recruiter

Design outcomes

Primary

MeasureTime frameDescription
BMI3-4 monthsChanges in BMI between the experimental group and intervention group at the beginning and end of the project

Secondary

MeasureTime frameDescription
Body composition--Fat (%)3-4 monthsChanges in Body composition including Fat (%) between the experimental group and intervention group at the beginning and end of the project.
Body composition--Body fat index (BFMI)3-4 monthsChanges in Body composition including Body fat index (BFMI) between the experimental group and intervention group at the beginning and end of the project.
Body composition--Fat-free mass index (FFMI)3-4 monthsChanges in Body composition including Fat-free mass index (FFMI) between the experimental group and intervention group at the beginning and end of the project.

Other

MeasureTime frameDescription
Blood indicators--uric acid3-4 monthsChanges in blood indicators including uric acid between the experimental group and intervention group at the beginning and end of the of the project.
Blood indicators--urea3-4 monthsChanges in blood indicators including urea between the experimental group and intervention group at the beginning and end of the of the project.
Blood indicators--blood sugar3-4 monthsChanges in blood indicators including blood sugar between the experimental group and intervention group at the beginning and end of the of the project.
Blood indicators--triglyceride3-4 monthsChanges in blood indicators including triglyceride between the experimental group and intervention group at the beginning and end of the of the project.
Blood indicators--cholesterol3-4 monthsChanges in blood indicators including cholesterol between the experimental group and intervention group at the beginning and end of the of the project.
questionnaire investigation3-4 monthsChanges in questionnaire investigation(involving diet, exercise, and obesity awareness) between the experimental group and intervention group at the beginning and end of the project
Blood indicators--low density lipoprotein3-4 monthsChanges in blood indicators including low density lipoprotein between the experimental group and intervention group at the beginning and end of the of the project.
Blood indicators--VD3-4 monthsChanges in blood indicators including VD between the experimental group and intervention group at the beginning and end of the of the project.
Blood indicators--VA3-4 monthscators including VA between the experimental group and intervention group
Blood indicators--ferritin3-4 monthscators including ferritin between the experimental group and intervention group
Blood indicators--high-density3-4 monthsChanges in blood indicators including high-density lipoprotein between the experimental group and intervention group at the beginning and end of the of the project.
Blood indicators--ALT3-4 monthsChanges 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.
Blood indicators--AST3-4 monthsChanges 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.
Blood indicators--creatinine3-4 monthsChanges in blood indicators including creatinine between the experimental group and intervention group at the beginning and end of the of the project.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026