NCT01030107

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

October 5, 2012

Status Verified

April 1, 2011

Enrollment Period

2.9 years

First QC Date

December 9, 2009

Last Update Submit

October 4, 2012

Conditions

Keywords

sleepobesitychildreneating behaviorsactivityleptinghrelin

Outcome Measures

Primary Outcomes (1)

  • absolute reinforcing value of food as compared to sedentary activities

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

Secondary Outcomes (4)

  • plasma levels of leptin and ghrelin

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

  • caloric intake

    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

    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

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

Study Arms (1)

Children with Insufficient Sleep

Children who sleep approximately 9-10 hours/night

Behavioral: Increase SleepBehavioral: Decrease Sleep

Interventions

Increase SleepBEHAVIORAL

Children are asked to increase their sleep by approximately 1 1/2 hours/night for 1 week.

Children with Insufficient Sleep
Decrease SleepBEHAVIORAL

Children are asked to decrease their sleep by approximately 1 1/2 hours/night.

Children with Insufficient Sleep

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children ages 8-11 years old recruited from Southeastern New England.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 ml of whole blood drawn at each of 3 assessments

MeSH Terms

Conditions

ObesityFeeding BehaviorMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Chantelle N Hart, PhD

    The Miriam Hospital/Alpert Medical School of Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 11, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

October 5, 2012

Record last verified: 2011-04

Locations