Dietary Habits and Sleep in Childhood Obesity (INFOB)
Sleep and Nutrition Intervention in Obese Children, Effects on Circadian Rhythms, Metabolic and Inflammatory Status
Recruitment of obese children, classification according to sleep questionnaire and randomization in two groups to perform nutritional and sleep intervention. .
One group receives dietary intervention through recommendations. A group receives dietary and sleep intervention through recommendations. An analysis of the melatonin profile and metabolic and inflammatory status is performed by biochemistry at the beginning and end of the intervention. Determine if the intervention has improved the health of obese children.
研究概览
详细说明
This study is carried out in children aged 7 to 14 years who are overweight or obese, in which their state and circadian rhythm variation are related by means of melatonin, biochemistry and dietary and sleep questionnaires.
An intervention is performed in which patients are classified in evening and morning. After the classification, a randomized randomization is carried out in which one group receives dietary recommendations and another group receives dietary and sleep recommendations. After 6 months of follow-up the analyzes are performed again to observe possible differences with the initial values and compare it between both groups.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Valencia、西班牙、46010
- 招聘中
- Pilar Codoñer Franch
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接触：
- PILAR CODOÑER
- 电话号码：+34 670320624
- 邮箱：pilar.codoner@uv.es
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- children between 7 and 14 years old
- overweight or obese (Body Mass Index superior to 97th percentile for age and sex).
Exclusion Criteria:
- Medicine intake,
- hyperactivity,
- infectious inflammatory processes,
- elite athletes.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：sleep and diet intervention
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lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.
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有源比较器：diet intervention
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lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body mass index measurement, percentile for age and sex
大体时间：6 months
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comparative measurements prior after intervention
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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melatonin concentration profile in saliva
大体时间：6 months
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comparative measurements prior after intervention
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6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.