- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01030107
Effects of Sleep Duration on Eating and Activity Behaviors
4. oktober 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
37
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Weight Control and Diabetes Research Center
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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
8 år til 11 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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.
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Hvad måler undersøgelsen?
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
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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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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Chantelle N Hart, PhD, The Miriam Hospital/Alpert Medical School of Brown University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Hjælpsomme links
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
1. februar 2009
Primær færdiggørelse (Faktiske)
1. januar 2012
Studieafslutning (Faktiske)
1. januar 2012
Datoer for studieregistrering
Først indsendt
9. december 2009
Først indsendt, der opfyldte QC-kriterier
10. december 2009
Først opslået (Skøn)
11. december 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. oktober 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. oktober 2012
Sidst verificeret
1. april 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1-08-JF-17
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 .
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