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Sleep, Nutrition and Psychological Functioning in Kindergarten Children

10. marts 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

140

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

3 år til 6 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Healthy Nutrition Intervention
Healthy Nutrition Intervention (HNI)
Adfærdsmæssigt: 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.
Eksperimentel: Healthy Sleep Intervention
Healthy Sleep Intervention (HSI)
Adfærdsmæssigt: 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).
Ingen indgriben: Waiting list control
Waiting list control group

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 week post-intervention, 6 month follow up
1 week post-intervention, 6 month follow up
Change in parent reported sleep problems (BCSQ)
Tidsramme: Baseline, 1 week post-intervention
Baseline, 1 week post-intervention
Change in parent reported sleep problems (BCSQ)
Tidsramme: baseline, 6 month follow up
baseline, 6 month follow up
Change in parent reported sleep problems (BCSQ)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in child reported sleep and eating problems
Tidsramme: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in child reported sleep and eating problems
Tidsramme: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in child reported sleep and eating problems
Tidsramme: 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
Tidsramme: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in parent reported nutrition habits of the child and family
Tidsramme: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in parent reported nutrition habits of the child and family
Tidsramme: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tel Aviv University

Samarbejdspartnere

Israel Science Foundation

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2014

Primær færdiggørelse (Faktiske)

1. november 2018

Studieafslutning (Faktiske)

1. december 2019

Datoer for studieregistrering

Først indsendt

16. februar 2014

Først indsendt, der opfyldte QC-kriterier

19. februar 2014

Først opslået (Skøn)

24. februar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • RMB-0425-13

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Forebyggelse af skadelige virkninger

Kliniske forsøg med Healthy Nutrition intervention

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