Healthy Weight Management Project for Overweight and Obesity Children

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. Nonalcoholic fatty liver disease (NAFLD) is tightly associated with obesity, in China, the prevalence of NAFLD in obesity children is 40.0%，the main interventions for NAFLD are lifestyle interventions. Effective strategies to helping students lose weight and alleviate NAFLD through lifestyle interventions may help promote the physical and mental health of obese students. This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in treating childhood overweight and obesity; (2) to determine the sustainability of the treatment in preventing overweight and obesity; (3) to help alleviate or reverse NAFLD in obesity children. Children with overweight and obesity in six primary schools in Ningbo City, Zhejiang Province will be seleted and randomly divided into two groups: the treatment group and the usual practice group. The participants of the study were students in the third grade of primary school, and the treatment will last for one academic year. This treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.

Official Title
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Healthy Weight Management Project for Overweight and Obesity Children in Ningbo City

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Lifestyle intervention


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 and 10 years old; students with childhood overweight/obesity defined according to the criteria for Chinese children and adolescents. 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity. | Behavioral: Lifestyle intervention<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 treatment 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 Diet and exercise instruction by professional nutritionist using internet applet Take part in sports activities that are organized by the sports health teacher during school hours.<br>|
| No Intervention: Usual practice group<br>No intervention | |

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 | 3 months，9 months , 24 months and 36 months | 
| change in controlled attenuation parameters (CAP) | CAP will be detected by Fibroscan caculated by terminal value minus baseline value | 3 months，9 months , 24 months and 36 months | 
| Change in liver stiffness measurement (LSM) | LSM will be detected by Fibroscan caculated by terminal value minus baseline value | 3 months，9 months , 24 months and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI z- score | BMI z- score are measures of relative weight adjusted for child age and sex caculated by terminal value minus baseline value | 3 months，9 months , 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 | 3 months and 9 months | 
| change in waist circumference | caculated by terminal value minus baseline value | 3 months，9 months , 24 months and 36 months | 
| change in weight | caculated by terminal value minus baseline value | 3 months，9 months , 24 months and 36 months | 
| change in cardiorespiratory endurance test | caculated by terminal value minus baseline value | 3 months，9 months , 24 months and 36 months | 
| change in ALT(alanine transaminase) | caculated by terminal value minus baseline value | 9 months |