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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

Betingelser

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

    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Weight Control and Diabetes Research Center

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
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.

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
after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration

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
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
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
after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
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
after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration

Samarbejdspartnere og efterforskere

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

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.

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

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 .

Kliniske forsøg med Increase Sleep

3
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