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

Not Applicable

Completed

• Conditions: Pediatric Obesity
• Interventions: Behavioral: The Health Lifestyles Interventions

• Registration Number: NCT02343588
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-06
• Status Verified: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-22
• Last Update Submitted: 2015-01-22
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Health Lifestyles Interventions	The Health Lifestyles Interventions	1. Creating a supportive school, family and community environment; 2. Health lifestyles educational strategies; 3. Instruct and promote school physical education; 4. The monitoring and instruction of obesity related behaviors (focus group)

Primary Outcome Measures

Name	Time	Method
Change in the prevalence of overweight and obesity	Baseline, Month 9

Secondary Outcome Measures

Name	Time	Method
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
Change in obesity related anthropometric measurements (waist circumference, hip circumference, blood pressure and skin fold thickness)	Baseline, Month 9