Randomised Controlled Clinical Trial Comparing Two Family Interventions to Treat Obesity in Children Between 7 and 12 Years.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- BMI-SDS
研究概览
简要总结
The study compares the effect on BMI of two different treatment options for obesity in childhood. Families with at least one obese child and parent are invited to join the project. The hypothesis is that family camp gives an additional reduction in BMI compared to a less intensive family lifestyle school.
详细描述
Participants are randomised to two intervention groups:
A): Two weeks family camp and two years follow-up as a cooperation with primary health care, private rehabilitation center and specialist health care.
B): Four days lifestyle school with two years follow-up as a cooperation with primary health care and specialist health care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 7 to 12 years
- •BMI > iso-BMI 30 (Coles index)
排除标准
- •syndromatic obesity
- •obesity related to diseases
- •local community not involved
- •child has present follow-up because of obesity in secondary health care
- •parent has present/planned follow-up because of obesity in secondary health care
结局指标
主要结局
BMI-SDS
时间窗: After 2 years
Primary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight.
次要结局
- Quality of life(After 2 years)
- Blood samples(After 2 years)
- Physical fitness(After 2 years)
- Behaviour(After 2 years)
研究者
Samira Lekhal
MD, PhD, Head Children department Morbid Obesity Center
Sykehuset i Vestfold HF