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
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
研究点 (1)
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