Sleep, Nutrition and Psychological Functioning in Kindergarten Children
2020年3月10日 更新者：Michal Kahn、Tel Aviv University
Sleep, Nutrition and Psychological Functioning in Kindergarten Children: A Longitudinal Intervention Study
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.
研究概览
研究类型
介入性
注册 (实际的)
140
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Tel Aviv、以色列、69978
- Tel Aviv University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
3年 至 6年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Preschool children (aged 3-6 years) and their parents
Exclusion Criteria:
- (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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Healthy Nutrition Intervention
Healthy Nutrition Intervention (HNI)
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Healthy Nutrition Intervention (HNI)- This online system will include information for parents on the following issues: (a) increasing awareness and making healthy food choices; (b) increasing appeal of healthy food by games, rewards, and child involvement in preparation and cooking; (c) setting rules regarding proper eating environment, family meals and schedules; (d) limiting the presence of unhealthy food and beverage temptations at home; (e) limiting TV and other screen time and increasing physical activities; (f) encouraging parents to be positive role models for all these principles.
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实验性的：Healthy Sleep Intervention
Healthy Sleep Intervention (HSI)
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Healthy Sleep Intervention (HSI)- This online interactive e-learning system will include information for parents on the following topics: (a) establishing appropriate bedtime, including how to assess the sleep needs of their child, how to establish regular bedtime and overall sleep schedule, how to deal with daytime naps; (b) establishing a regular and enjoyable bedtime routine (e.g.
bedtime stories); (c) coping with bedtime resistance, setting limits to excessive demands, rewarding appropriate sleep related behaviors; (d) coping with bedtime and nighttime fears, strategies to deal with separation anxieties, fears of darkness, scary imaginative creatures etc; (e) coping with excessive night-wakings and eliminating potential reinforcing consequences; (f) coping with nightmares, night terrors and other parasomnias (e.g., night-walking).
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无干预：Waiting list control
Waiting list control group
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
大体时间：Baseline, 1 week post-intervention
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Baseline, 1 week post-intervention
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Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
大体时间：Baseline, 6-month follow up
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Baseline, 6-month follow up
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Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
大体时间：1 week post-intervention, 6 month follow up
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1 week post-intervention, 6 month follow up
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Change in parent reported sleep problems (BCSQ)
大体时间：Baseline, 1 week post-intervention
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Baseline, 1 week post-intervention
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Change in parent reported sleep problems (BCSQ)
大体时间：baseline, 6 month follow up
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baseline, 6 month follow up
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Change in parent reported sleep problems (BCSQ)
大体时间：1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
大体时间：Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
大体时间：Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
大体时间：1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Change in child reported sleep and eating problems
大体时间：Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in child reported sleep and eating problems
大体时间：Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in child reported sleep and eating problems
大体时间：1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Change in parent reported nutrition habits of the child and family
大体时间：Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in parent reported nutrition habits of the child and family
大体时间：Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in parent reported nutrition habits of the child and family
大体时间：1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change in child psychopathological symptoms (SDQ)
大体时间：Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in child psychopathological symptoms (SDQ)
大体时间：Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in child psychopathological symptoms (SDQ)
大体时间：1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Change in child attention control abilities (computerized tests)
大体时间：Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in child attention control abilities (computerized tests)
大体时间：Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in child attention control abilities (computerized tests)
大体时间：1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Change in child anthropometric measures (height, weight, blood pressure)
大体时间：Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in child anthropometric measures (height, weight, blood pressure)
大体时间：Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in child anthropometric measures (height, weight, blood pressure)
大体时间：1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Change in reported parental Authority (PAQ-R)
大体时间：Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in reported parental Authority (PAQ-R)
大体时间：Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in reported parental Authority (PAQ-R)
大体时间：1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Change in cry tolerance and limit setting abilities
大体时间：Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in cry tolerance and limit setting abilities
大体时间：Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in cry tolerance and limit setting abilities
大体时间：1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Avi Sadeh, Ds.c.、Tel Aviv University
- 首席研究员：Geila Rozen, PhD、Rambam Health Care Campus
- 首席研究员：Ron Shaoul, M.D.、Rambam Health Care Campus
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年3月1日
初级完成 (实际的)
2018年11月1日
研究完成 (实际的)
2019年12月1日
研究注册日期
首次提交
2014年2月16日
首先提交符合 QC 标准的
2014年2月19日
首次发布 (估计)
2014年2月24日
研究记录更新
最后更新发布 (实际的)
2020年3月12日
上次提交的符合 QC 标准的更新
2020年3月10日
最后验证
2020年3月1日
更多信息
与本研究相关的术语
其他研究编号
- RMB-0425-13
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.
Healthy Nutrition intervention的临床试验
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University of Texas at AustinUniversity of Maryland; The University of Texas Health Science Center at San Antonio; The University...主动，不招人
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人