Sleep, Nutrition and Psychological Functioning in Kindergarten Children
10 mars 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
140
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Tel Aviv, Israel, 69978
- Tel Aviv University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
3 år till 6 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Experimentell: 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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Inget ingripande: Waiting list control
Waiting list control group
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Change in child psychopathological symptoms (SDQ)
Tidsram: Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in child psychopathological symptoms (SDQ)
Tidsram: Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in child psychopathological symptoms (SDQ)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Avi Sadeh, Ds.c., Tel Aviv University
- Huvudutredare: Geila Rozen, PhD, Rambam Health Care Campus
- Huvudutredare: Ron Shaoul, M.D., Rambam Health Care Campus
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2014
Primärt slutförande (Faktisk)
1 november 2018
Avslutad studie (Faktisk)
1 december 2019
Studieregistreringsdatum
Först inskickad
16 februari 2014
Först inskickad som uppfyllde QC-kriterierna
19 februari 2014
Första postat (Uppskatta)
24 februari 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 mars 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 mars 2020
Senast verifierad
1 mars 2020
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- RMB-0425-13
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .