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临床试验/NCT01161212
NCT01161212已完成不适用

Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren

University of Nancy2 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2005年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,600
试验地点
2
主要终点
Body mass index (BMI) and waist circumference

研究概览

简要总结

In French primary schools, children participate in 3 compulsory hours of physical education (PE) each week unless they have a medical contra-indication. But, there is no scientific evidence (randomized trial) that a weekly physical activity splitting up of these 3 hours of PE brings or not the same effects, particularly to prevent overweight or obesity.

Regul'aps is a cluster randomized controlled trial which wants to evaluate whether splitting up the 3 hours into 3 or 4 sessions (vs. 1-2 sessions) of PE per week has an effect on speed of a BMI increase and on health-related quality of life (HRQoL) over the school year.

Study hypothesis: reduction of speed of increase of BMI and an increase of HRQoL

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • All teachers under the cover of the headmasters in charge of classes from grades 2 to 5 in 2 counties in the Lorraine region of France (Meurthe-et-Moselle and Vosges [District of Golbey])
  • headmasters or teachers had to agree to modify the organisation of PE sessions

排除标准

  • Classes composed only of 2d grade
  • Set schedule of physical educational sessions

结局指标

主要结局

Body mass index (BMI) and waist circumference

时间窗: September 2006 and June 2007

September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later)

次要结局

  • Health-related quality of life(September 2006 and June 2007)

研究者

发起方
University of Nancy
申办方类型
Other

研究点 (2)

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