Sleep and Nutrition Intervention in Obese Children, Effects on Circadian Rhythms, Metabolic and Inflammatory Status
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Body mass index measurement, percentile for age and sex
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children between 7 and 14 years old
- •overweight or obese (Body Mass Index superior to 97th percentile for age and sex).
排除标准
- •Medicine intake,
- •hyperactivity,
- •infectious inflammatory processes,
- •elite athletes.
研究组 & 干预措施
sleep and diet intervention
干预措施: sleep and diet intervention vs diet intervention (Behavioral)
diet intervention
干预措施: sleep and diet intervention vs diet intervention (Behavioral)
结局指标
主要结局
Body mass index measurement, percentile for age and sex
时间窗: 6 months
comparative measurements prior after intervention
次要结局
- melatonin concentration profile in saliva(6 months)
研究者
Pilar Codoñer-Franch
Head of Pediatrics, Principal Investigator, Clinical Professor
University of Valencia