- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01030107
Effects of Sleep Duration on Eating and Activity Behaviors
4. oktober 2012 oppdatert av: The Miriam Hospital
Sleep Duration and Pediatric Overweight: the Role of Eating Behaviors
The purpose of the proposed study is to determine whether the amount children sleep is associated with changes in hormones, hunger, motivation to eat, and food intake.
Fifty children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study.
For 1 week each, children will be asked to sleep their typical amount, increase their sleep by 1-½ hours, and decrease their sleep by 1-½ hours.
Half of the children will be asked to increase their sleep first and half to decrease their sleep first.
During each week, the following will be gathered: sleep duration (measured by actigraphy, which is a small device that measures sleep), levels of hormones measured through blood draws, self-reported hunger and appetite, food intake (measured by 3 days of 24-hour recall), how motivated children are to eat (measured using a computer activity), and child height and weight.
We believe that when children sleep less they will show changes in hormones associated with hunger and appetite, report being hungrier, be more motivated to eat, and eat more food.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
37
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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Rhode Island
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Providence, Rhode Island, Forente stater, 02903
- Weight Control and Diabetes Research Center
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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
8 år til 11 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Children ages 8-11 years old recruited from Southeastern New England.
Beskrivelse
Inclusion Criteria:
- Age 8-11 years old
- BMI for age and gender > 5th percentile (but no greater than 100% overweight)
- Sleep approximately 9-10 hours nightly
- Attend elementary school
- Like at least 1 food and 1 activity used in the reinforcement paradigm
- Able to understand and complete the reinforcement paradigm
Exclusion Criteria:
- Existence of a diagnosable sleep disorder
- Medical or psychiatric condition that could influence sleep or weight
- Onset of menarche
- Inability to complete study materials, including diagnosed disabilities
- Dietary restrictions/allergies to foods used in the study that preclude them from study participation
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Children with Insufficient Sleep
Children who sleep approximately 9-10 hours/night
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Children are asked to increase their sleep by approximately 1 1/2 hours/night for 1 week.
Children are asked to decrease their sleep by approximately 1 1/2 hours/night.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
absolute reinforcing value of food as compared to sedentary activities
Tidsramme: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
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after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
plasma levels of leptin and ghrelin
Tidsramme: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
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after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
|
caloric intake
Tidsramme: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
|
after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
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levels of physical activity
Tidsramme: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
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after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
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subjective ratings of hunger and appetite
Tidsramme: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
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after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
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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: Chantelle N Hart, PhD, The Miriam Hospital/Alpert Medical School of Brown University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Hart CN, Spaeth AM, Egleston BL, Carskadon MA, Raynor HA, Jelalian E, Owens JA, Considine RV, Wing RR. Effect of changes in children's bedtime and sleep period on targeted eating behaviors and timing of caloric intake. Eat Behav. 2022 Apr;45:101629. doi: 10.1016/j.eatbeh.2022.101629. Epub 2022 Mar 26.
- Hart CN, Carskadon MA, Considine RV, Fava JL, Lawton J, Raynor HA, Jelalian E, Owens J, Wing R. Changes in children's sleep duration on food intake, weight, and leptin. Pediatrics. 2013 Dec;132(6):e1473-80. doi: 10.1542/peds.2013-1274. Epub 2013 Nov 4.
Hjelpsomme linker
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
1. februar 2009
Primær fullføring (Faktiske)
1. januar 2012
Studiet fullført (Faktiske)
1. januar 2012
Datoer for studieregistrering
Først innsendt
9. desember 2009
Først innsendt som oppfylte QC-kriteriene
10. desember 2009
Først lagt ut (Anslag)
11. desember 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
5. oktober 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. oktober 2012
Sist bekreftet
1. april 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1-08-JF-17
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. .
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