Optimizing Intervention Effects in Children and Adolescents

Study Overview
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Brief Summary
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Childhood obesity is a significant public health concern worldwide. In China, childhood obesity has dramatically increased as the economy has grown quickly over the past decades. Effective strategies to reduce childhood obesity prevalence may help to prevent related chronic diseases in the whole population in the long term. This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in preventing childhood overweight and obesity; (2) to determine the sustainability of the intervention in preventing overweight and obesity; and (3) to evaluate the process and health economics of the intervention. The project will be carried out in six primary schools in Ningbo City, Zhejiang Province , those schools are randomly divided into two groups: the intervention group and the usual practice group. The participants of the study were students in the third grade of primary school, and the intervention will last for one academic year. This intervention programme will target the influencing factors of childhood obesity at both individual (student-focused activities) and environmental levels (a supportive family and school environment), with the intent to influence the knowledge, attitude and behaviours of school children.

Official Title
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Optimizing Intervention Effects in Children and Adolescents in Ningbo City

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Multi-faceted health promotion programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents agree and support their children's weight loss, and students and parents have informed consent; Students in third grade aged 8 to 10 years old. Exclusion Criteria: medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, hepatitis or nephritis; obesity caused by endocrine diseases or side effects of drugs; abnormal physical development like dwarfism or gigantism; physical deformity such as severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg; inability to participate in school sport activities; a loss in weight by vomiting or taking drugs during the past 3 months.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The students of this group will receive multi-faceted intervention activities toward weight management. | Behavioral: Multi-faceted health promotion programme<br>* This intervention programme will target the influencing factors of childhood obesity to influence the knowledge, attitude and behaviours of school children. Students in the intervention group will receive the following interventions: Develop and implement school policies related to weight loss Distribute health education materials on diet and exercise to students Carry out student health education courses<br>|
| No Intervention: Usual practice group<br>The students of this group will receive regular health education. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body mass index (BMI） | weight and height will be combined to report BMI in kg/m^2 caculated by terminal value minus baseline value | 9months , 24 months and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in BMI z- score | measures of relative weight adjusted for child age and sex caculated by terminal value minus baseline value | 9months , 24 months and 36 months | 
| change in blood glucose | caculated by terminal value minus baseline value | 9 months | 
| change in blood lipids | include TC, TG, LDL-C, HDL-C caculated by terminal value minus baseline value | 9 months | 
| change in fasting insulin | caculated by terminal value minus baseline value | 9 months | 
| change in body fat percentage | caculated by terminal value minus baseline value | 9 months | 
| change in waist circumference | caculated by terminal value minus baseline value | 9 months, 24 months and 36 months | 
| change in weight | caculated by terminal value minus baseline value | 9months, 24 months and 36 months | 
| change in cardiorespiratory endurance test | caculated by terminal value minus baseline value | 9 months, 24 months and 36 months |