NCT00998413已完成不适用
Secondary Prevention of Asthma in Overweight/Obese Children by a Combined Dietary-behavioural-physical Activity Intervention
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Forced Expiratory Volume in the first second (FEV1 %) predicted value
研究概览
简要总结
The purpose of this study is to determine the efficacy of a multifactorial intervention with weight reduction, behavioural therapy, and physical exercise on the severity and control of asthma in obese children.
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
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-16 years
- •BMI in the overweight/obesity range according to data of Cole et al.
- •Asthma diagnosis
排除标准
- •Children with a normal weight according to data of Cole et al.
- •Children without any provable asthmatic complaints
- •Congenital malformations of the airways or other chronic lung diseases like cystic fibrosis (CF)
- •Mental retardation or syndromes
- •Heart disease
研究组 & 干预措施
Multifaceted intervention
Experimental
Multifaceted intervention:physical exercise, nutrition, and behavioural intervention.
干预措施: Multifaceted intervention (Behavioral)
Control
No Intervention
standard usual care
结局指标
主要结局
Forced Expiratory Volume in the first second (FEV1 %) predicted value
时间窗: 2 years
次要结局
- Airway inflammation(2 years)
- Symptom-free days, exacerbations(2 years)
- Need for beta-2 agonists/anti-inflammatory medication(2 years)
- Weight, height, body mass index (BMI)(2 years)
- Levels of serum adipokines(2 years)
- aerobic capacity(2 years)
研究者
研究点 (2)
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