Development and Application of Appropriate Technology for Obesity Prevention and Control in Seven Centers in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70,000
- 主要终点
- Change in the prevalence of overweight and obesity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •grade of 1 to 5 in primary schools and grade of 6 to 8 and 10 to 11 in secondary schools.
排除标准
- •Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.
结局指标
主要结局
Change in the prevalence of overweight and obesity
时间窗: Baseline, Month 9
次要结局
- 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)
研究者
CHEN Yajun
Associate Professor
Sun Yat-sen University