Sleep, Nutrition and Psychological Functioning in Kindergarten Children
10 mars 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
140
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Tel Aviv, Israël, 69978
- Tel Aviv University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
3 ans à 6 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Expérimental: 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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Aucune intervention: Waiting list control
Waiting list control group
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Change in child psychopathological symptoms (SDQ)
Délai: Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in child psychopathological symptoms (SDQ)
Délai: Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in child psychopathological symptoms (SDQ)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Avi Sadeh, Ds.c., Tel Aviv University
- Chercheur principal: Geila Rozen, PhD, Rambam Health Care Campus
- Chercheur principal: Ron Shaoul, M.D., Rambam Health Care Campus
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mars 2014
Achèvement primaire (Réel)
1 novembre 2018
Achèvement de l'étude (Réel)
1 décembre 2019
Dates d'inscription aux études
Première soumission
16 février 2014
Première soumission répondant aux critères de contrôle qualité
19 février 2014
Première publication (Estimation)
24 février 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 mars 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 mars 2020
Dernière vérification
1 mars 2020
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- RMB-0425-13
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .