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临床试验/NCT02069249
NCT02069249已完成不适用

Sleep, Nutrition and Psychological Functioning in Kindergarten Children: A Longitudinal Intervention Study

Tel Aviv University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures

研究概览

简要总结

The proposed study has the following aims: (a) to assess the concomitant and longitudinal links between sleep and cognitive, behavioral and emotional functioning in kindergarten children; (b) to assess the immediate and the long-term effects of an intervention to promote healthy sleep habits (HSI) on the child's evolving sleep patterns, as well as on related cognitive, behavioral and health domains; (c) to assess the immediate and the long-term effects of an intervention deigned to promote healthy nutrition (HNI) on the eating habits of children, their weight and BMI measures (the comparison/control group) and (d) to assess the links between eating habits and sleep in kindergarten children.

The main hypotheses of the proposed study are: (a) Shorter and more disrupted sleep would be concomitantly and longitudinally associated with compromised cognitive, emotional and behavioral functioning in kindergarten children; (b) In comparison to the HNI group, children in the HSI group will extend their total sleep time, improve their sleep quality and their sleep schedule will be more stable following the intervention; (c) improvement in sleep habits will be associated with improvement in cognitive, emotional and behavioral functioning; (d) in comparison to the HIS group, children in the HNI group will improve their eating habits, engage in more physical activities and better manage to achieve and maintain an age-appropriate body weight.

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
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Preschool children (aged 3-6 years) and their parents

排除标准

  • (a) significant health or neurological-developmental problems; (b) severe psychological problems, psychiatric diagnosis or treatment; (c) concurrent psychotherapy or similar interventions; (d) medical sleep problems (e.g., sleep apnea); (e) lack of mastery in Hebrew.

结局指标

主要结局

Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures

时间窗: 1 week post-intervention, 6 month follow up

Change in parent reported sleep problems (BCSQ)

时间窗: 1 week post intervention, 6 month follow up

Change in child reported sleep and eating problems

时间窗: 1 week post intervention, 6 month follow up

Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)

时间窗: 1 week post intervention, 6 month follow up

Change in parent reported nutrition habits of the child and family

时间窗: 1 week post intervention, 6 month follow up

次要结局

  • Change in child psychopathological symptoms (SDQ)(1 week post intervention, 6 month follow up)
  • Change in child anthropometric measures (height, weight, blood pressure)(1 week post intervention, 6 month follow up)
  • Change in cry tolerance and limit setting abilities(1 week post intervention, 6 month follow up)
  • Change in child attention control abilities (computerized tests)(1 week post intervention, 6 month follow up)
  • Change in reported parental Authority (PAQ-R)(1 week post intervention, 6 month follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michal Kahn

PhD student, Laboratory for Children's Sleep-Wake Disorders

Tel Aviv University

研究点 (2)

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