Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- BMI
研究概览
简要总结
Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.Patients will be randomly allocated into one of two behavior intervention groups or control group in ratio of 1:1:1.The study will consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in al 3 groups) at months 0, 3, 12 and 24.
详细描述
Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.
Objectives:
- To develop an intervention program for obesity prevention in children aged 5-10 years old, who are at risk to develop obesity
- To compare between the efficacy of two different intervention programs and a control group in preventing obesity in the short and the long term.
- To evaluate the role and significance of including parents in an intervention program for obesity prevention.
- To identify demographic parameters, lifestyle characteristic and biochemical markers that predict the risk of developing obesity and the response for treatment.
Randomization:
Patients will be randomly allocated into one of two intervention groups or control group in ratio of 1:1:1. Each group will contain 12-15 participants.
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
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 5-10 years old
- •BMI in 85-98 percentile
- •Both parents signing informed consent form
排除标准
- •Chronic disease or chronic use of medication
- •Incapability to perform all study procedure
结局指标
主要结局
BMI
时间窗: 24 month
次要结局
未报告次要终点