A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity

Study Overview
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Brief Summary
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The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in China. In each center, about 12-16 primary and secondary schools, with totally at least 10000 participants were randomly selected (Primary: Secondary=1:1). All of the selected schools were randomly allocated to either intervention or control group (Intervention: Control=1:1).The multi-components school-based and family-involved scheme was conducted within the intervention group for 9 month, while students in the control group followed their usual health practice. The intervention consisted of four components: a) Create supportive school and family environment, b) Health lifestyles education and related compulsory physical activities, c) Instruct and promote school physical education, d) Self-monitor obesity related behaviors. Four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program.

Official Title
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Development and Application of Appropriate Technology for Obesity Prevention and Control in Seven Centers in China

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Behavioral: The Health Lifestyles Interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: grade of 1 to 5 in primary schools and grade of 6 to 8 and 10 to 11 in secondary schools. Exclusion Criteria: Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Health Lifestyles Interventions<br>Creating a supportive school, family and community environment; Health lifestyles educational strategies; Instruct and promote school physical education; The monitoring and instruction of obesity related behaviors (focus group) | Behavioral: The Health Lifestyles Interventions<br>* Creating supportive school and family environment, whole intervention periods; Health lifestyles educational strategies, 30min/week for education lessons and six times education activities; Instruct and promote school physical education, whole intervention periods; The monitoring and instruction of obesity related behaviors, once a week for physical activity and dietary behavioral log and once a month for parental monitor<br>|
| No Intervention: Receive no intervention<br>Usual practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the prevalence of overweight and obesity |  | Baseline, Month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in obesity related anthropometric measurements (waist circumference, hip circumference, blood pressure and skin fold thickness) |  | Baseline, Month 9 | 
| Change in physical activity and dietary behaviors (Dietary, sedentary or physical activity behaviors and their determents, as measured by validated questionnaires (parent, children and school version) |  | Baseline, Month 9 | 
| Change in serum lipids and fasting glucose (fasting plasma glucose, fasting triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) |  | Baseline, Month 9 | 
| Change in physical fitness (standing-board jump, 50 meters speed run, 50 meters × 8 shuttle run (primary students) and run 800/1000 meters (secondary school students) |  | Baseline, Month 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese multi-centered school based obesity intervention