Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562465
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Prevention and Intervention of Overweight and Obesity in Preschool Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Research on Prevention and Intervention of Overweight and Obesity in Preschool Children
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens health reducing disease burden promoting childrens health emphasizing the principle of prevention first and combining prevention and treatment Given the current status of childrens 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 childrens 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 childrens 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 childrens healthcare clothing and provide small-scale policy research references for the implementation of support systems for childrens 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 NZ α2Z β 2 σ 2 Q1-1Q2-1δ 2 If the difference in BMI decrease between the two groups after intervention is 058 and if σ12 and α is taken as 005 on both sides the test power is 08 Q1Q205σ12δ058Z0052196Zβ0842 Calculate N1960842 2 122 05-105-10582 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 260 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 005 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
5Ethical 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 Patients 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 patients health information remains valid until the study is completed After that researchers will delete private information from the study record
2 The sample size for comparing the means of the two groups is NZ α2Z β 2 σ 2 Q1-1Q2-1δ 2 If the difference in BMI decrease between the two groups after intervention is 058 and if σ12 and α is taken as 005 on both sides the test power is 08 Q1Q205σ12δ058Z0052196Zβ0842 Calculate N1960842 2 122 05-105-10582 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 260 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 005 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
5Ethical 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 Patients 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 patients health information remains valid until the study is completed After that researchers will delete private information from the study record
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None