Sleep, Nutrition and Psychological Functioning in Kindergarten Children
10. mars 2020 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
140
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Tel Aviv, Israel, 69978
- Tel Aviv University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
3 år til 6 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Ingen inngripen: Waiting list control
Waiting list control group
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Change in child psychopathological symptoms (SDQ)
Tidsramme: Baseline, 1 week post intervention
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Baseline, 1 week post intervention
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Change in child psychopathological symptoms (SDQ)
Tidsramme: Baseline, 6 month follow up
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Baseline, 6 month follow up
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Change in child psychopathological symptoms (SDQ)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 week post intervention, 6 month follow up
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1 week post intervention, 6 month follow up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Avi Sadeh, Ds.c., Tel Aviv University
- Hovedetterforsker: Geila Rozen, PhD, Rambam Health Care Campus
- Hovedetterforsker: Ron Shaoul, M.D., Rambam Health Care Campus
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2014
Primær fullføring (Faktiske)
1. november 2018
Studiet fullført (Faktiske)
1. desember 2019
Datoer for studieregistrering
Først innsendt
16. februar 2014
Først innsendt som oppfylte QC-kriteriene
19. februar 2014
Først lagt ut (Anslag)
24. februar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mars 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- RMB-0425-13
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .