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.
調査の概要
研究の種類
介入
入学 (実際)
140
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Tel Aviv、イスラエル、69978
- Tel Aviv University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
3年～6年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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実験的：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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介入なし：Waiting list control
Waiting list control group
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change in child psychopathological symptoms (SDQ)
時間枠：Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in child psychopathological symptoms (SDQ)
時間枠：Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in child psychopathological symptoms (SDQ)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Avi Sadeh, Ds.c.、Tel Aviv University
- 主任研究者：Geila Rozen, PhD、Rambam Health Care Campus
- 主任研究者：Ron Shaoul, M.D.、Rambam Health Care Campus
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2014年3月1日
一次修了 (実際)
2018年11月1日
研究の完了 (実際)
2019年12月1日
試験登録日
最初に提出
2014年2月16日
QC基準を満たした最初の提出物
2014年2月19日
最初の投稿 (見積もり)
2014年2月24日
学習記録の更新
投稿された最後の更新 (実際)
2020年3月12日
QC基準を満たした最後の更新が送信されました
2020年3月10日
最終確認日
2020年3月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- RMB-0425-13
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Healthy Nutrition interventionの臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)募集
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Emory UniversityCenters for Disease Control and Prevention完了
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University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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University of LiverpoolLondon School of Hygiene and Tropical Medicine; National Institute of Mental Health (NIMH)完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない