Effects of Sleep Duration on Eating and Activity Behaviors

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01030107
First received: December 9, 2009
Last updated: October 4, 2012
Last verified: April 2011
  Purpose

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.


Condition Intervention
Sleep
Obesity
Behavioral: Increase Sleep
Behavioral: Decrease Sleep

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sleep Duration and Pediatric Overweight: the Role of Eating Behaviors

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

2 ml of whole blood drawn at each of 3 assessments


Enrollment: 37
Study Start Date: February 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children with Insufficient Sleep
Children who sleep approximately 9-10 hours/night
Behavioral: Increase Sleep
Children are asked to increase their sleep by approximately 1 1/2 hours/night for 1 week.
Behavioral: Decrease Sleep
Children are asked to decrease their sleep by approximately 1 1/2 hours/night.

  Eligibility

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030107

Locations
United States, Rhode Island
Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
American Diabetes Association
Investigators
Principal Investigator: Chantelle N Hart, PhD The Miriam Hospital/Alpert Medical School of Brown University
  More Information

Additional Information:
No publications provided by The Miriam Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01030107     History of Changes
Other Study ID Numbers: 1-08-JF-17
Study First Received: December 9, 2009
Last Updated: October 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
sleep
obesity
children
eating behaviors
activity
leptin
ghrelin

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014