跳至主要内容
临床试验/NCT01188044
NCT01188044已完成不适用

Validating the Use of Accelerometers for the Study of Physical Activity Among Young Malawian Toddlers

Tampere University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Feasibility/acceptability

研究概览

简要总结

One way to assess impacts of nutrition supplements to health is to measure physical activity. Physical activity can be measured with small devices called "accelerometers". Before they can be used, the devices need to be validated in the population in question. Objectives of this study are to test accelerometers in field conditions and validate their use in 16-18 months old Malawian toddlers. This study does not have a pre-set hypothesis.

详细描述

Accelerometers have not been validated in children under 2 years of age. In this study 50 toddlers from Lungwena will be recruited. The participants will wear an ActiGraph GT3X+ -accelerometer fitted on their waist with an elastic belt for 7 days. During the measuring, they will have two videotaped one-hour activity observations while wearing and additional accelerometer device fitted on their ankle. The output from the two devices will be compared to observed activity classified with CPAF-method.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • signed informed consent from at least one guardian
  • age 16.00 months to 17.99 months
  • availability during the period of the study

排除标准

  • any guardian reported or observed illness that limits child's physical activity
  • a condition reported by the guardian that limits child's activity co-operate in the study
  • wasting (weight-for-height < 2 SD)
  • concurrent participation in any clinical trial with an intervention

结局指标

主要结局

Feasibility/acceptability

时间窗: 7-day accelerometer measurement

Proportion of participants (%) of wearing the accelerometer device for 4 days, 6 hours per day (defined from the accelerometer output data).

次要结局

  • Cut-off point values for sedentary, light, moderate, and vigorous activity(First one-hour observation)
  • Sensitivity and specificity of the determined cut-off point values(Second one-hour observation)
  • Intra- and inter-subject variation in time spent in different activity classes(7-day accelerometer measurement)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验