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临床试验/NCT00623844
NCT00623844已完成2 期

Prevention Through Acitivity in Kindergarten Trial

University of Wuerzburg0 个研究点目标入组 718 人开始时间: 2007年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
718
主要终点
motor skills

研究概览

简要总结

Objectives: The PAKT project shall evaluate the effects of an exercise intervention in kindergarten combined with an educational training of parents and kindergarten teachers on behavior and health status of children.

Study design: Baseline measurements were performed on more than 700 kindergarten children aged 43-67 months in May to July 2007. The kindergartens are located in and around Wuerzburg in Germany. Kindergartens were then randomized in an intervention (21 kindergartens) and a control (20 kindergartens) group. The intervention group offers a daily exercise class lasting at least 30 min. Parents and teachers of the children in the intervention program receive educational training. In addition, the children have activity homework involving the entire family. The control kindergartens keep their routine. Follow-up measurements of physical activity (actigraph), motor skills, body mass index, skinfold thickness, and blood pressure take place in January/February 2008, June/July 2008, and September/October 2008. The number of accidents in and outside of the kindergartens and the number of children missing the kindergarten due to infections are monitored continuously.

Use of results: If the PAKT program should proof effective, the results will be published in scientific journals and made public using the press. With the help of the GEK, the program will then be implemented nationwide in kindergartens.

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

年龄范围
43 Months 至 67 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children in participating kindergartens

排除标准

  • Health conditions restricting physical activity
  • Age < 43 months or > 67 months

结局指标

主要结局

motor skills

时间窗: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention

Composite score of several motor tasks

Physical activity

时间窗: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention

Accelerometry over 7 days

次要结局

  • adiposity(baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention)
  • blood pressure(baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention)
  • infections(baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention)
  • television viewing time(baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention)
  • accidents(baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention)

研究者

发起方
University of Wuerzburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helge Hebestreit

Prof. Dr. med.

University of Wuerzburg

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