- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01030107
Effects of Sleep Duration on Eating and Activity Behaviors
October 4, 2012 updated by: 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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
37
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Weight Control and Diabetes Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children ages 8-11 years old recruited from Southeastern New England.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
absolute reinforcing value of food as compared to sedentary activities
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma levels of leptin and ghrelin
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Chantelle N Hart, PhD, The Miriam Hospital/Alpert Medical School of Brown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
December 9, 2009
First Submitted That Met QC Criteria
December 10, 2009
First Posted (Estimate)
December 11, 2009
Study Record Updates
Last Update Posted (Estimate)
October 5, 2012
Last Update Submitted That Met QC Criteria
October 4, 2012
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-08-JF-17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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