跳至主要内容
临床试验/CTRI/2019/04/018834
CTRI/2019/04/018834进行中(未招募)1/2 期

Effect of a structured multifactorial program on physical activity levels and body composition in obese and overweight adolescent

National Council of Educational Research and Training1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年1月5日最近更新:

试验速览

阶段
1/2 期
状态
进行中(未招募)
入组人数
600
试验地点
1
主要终点
Physical activity

研究概览

简要总结

subjects were recuirted from the school. They were divided into three groups. Group A was given exercise and education about physical activity and healthy eating. Group B was given only exercise. Group C was asked to continue their regular activity. Exercise will be given for 45 minutes.

sample size has been recalculate using pilot study. New sample size is n=600 (200 in each group).

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
11.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • BMI higher than the 85th centile on the standard Centers for Disease Control (CDC) BMI-for-age growth charts.

排除标准

  • obesity due to identified genetic, metabolic or endocrine disease, they are undergoing treatment for psychiatric disorders, which are already diagnosed by the physician.
  • Unable to attend twice weekly sessions at the designated intervention locations, 3) They are assessed unsafe to participate by GP or Pediatrician.

结局指标

主要结局

Physical activity

时间窗: baseline, post intervention (6weeks), 3 weeks, 6 weeks and 9 weeks post intervention

Food intake patterns

时间窗: baseline, post intervention (6weeks), 3 weeks, 6 weeks and 9 weeks post intervention

次要结局

  • Body mass Index(2)Sedentary and physical activity behaviour)

研究者

申办方类型
Government funding agency

研究点 (1)

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