Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Sleep, Nutrition and Psychological Functioning in Kindergarten Children

10. März 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

140

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Israel
      • Tel Aviv, Israel, 69978
        • Tel Aviv University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

3 Jahre bis 6 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Healthy Nutrition Intervention
Healthy Nutrition Intervention (HNI)
Verhalten: Healthy Nutrition intervention
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.
Experimental: Healthy Sleep Intervention
Healthy Sleep Intervention (HSI)
Verhalten: Healthy Sleep intervention
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).
Kein Eingriff: Waiting list control
Waiting list control group

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Zeitfenster: Baseline, 1 week post-intervention
Baseline, 1 week post-intervention
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Zeitfenster: Baseline, 6-month follow up
Baseline, 6-month follow up
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Zeitfenster: 1 week post-intervention, 6 month follow up
1 week post-intervention, 6 month follow up
Change in parent reported sleep problems (BCSQ)
Zeitfenster: Baseline, 1 week post-intervention
Baseline, 1 week post-intervention
Change in parent reported sleep problems (BCSQ)
Zeitfenster: baseline, 6 month follow up
baseline, 6 month follow up
Change in parent reported sleep problems (BCSQ)
Zeitfenster: 1 week post intervention, 6 month follow up
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)
Zeitfenster: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
Zeitfenster: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
Zeitfenster: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in child reported sleep and eating problems
Zeitfenster: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in child reported sleep and eating problems
Zeitfenster: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in child reported sleep and eating problems
Zeitfenster: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in parent reported nutrition habits of the child and family
Zeitfenster: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in parent reported nutrition habits of the child and family
Zeitfenster: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in parent reported nutrition habits of the child and family
Zeitfenster: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Tel Aviv University

Mitarbeiter

Israel Science Foundation

Ermittler

  • Hauptermittler: Avi Sadeh, Ds.c., Tel Aviv University
  • Hauptermittler: Geila Rozen, PhD, Rambam Health Care Campus
  • Hauptermittler: Ron Shaoul, M.D., Rambam Health Care Campus

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2014

Primärer Abschluss (Tatsächlich)

1. November 2018

Studienabschluss (Tatsächlich)

1. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

16. Februar 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Februar 2014

Zuerst gepostet (Schätzen)

24. Februar 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. März 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. März 2020

Zuletzt verifiziert

1. März 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • RMB-0425-13

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Prävention schädlicher Wirkungen

Klinische Studien zur Healthy Nutrition intervention

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Qatar

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren