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Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01508793
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : December 5, 2016
Temple University
Information provided by (Responsible Party):
The Miriam Hospital

Brief Summary:
The proposed study aims to determine whether an intervention to increase sleep in school-age children is associated with positive changes in eating, activity behaviors and zBMI. One hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in sleep). Families of children in the optimize sleep group will be taught effective behavioral strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month follow-up, the following will be gathered: sleep duration (measured by actigraphy), food intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry), the relative reinforcing value (RRV) of food (measured using a validated experimental paradigm), and measured child height and weight.

Condition or disease Intervention/treatment Phase
Sleep Obesity Behavioral: Optimize Sleep Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
No Intervention: Control
Experimental: Optimize Sleep Behavioral: Optimize Sleep
Children are asked to increase their sleep by approximately 1 1/2 hours/night for the duration of the two month intervention

Primary Outcome Measures :
  1. Change in Sleep Duration [ Time Frame: Baseline, 2-weeks, and 2-months ]
    Measured with actigraphy

  2. Change in Dietary Intake [ Time Frame: Baseline, 2-weeks, and 2-months ]
    Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)

Secondary Outcome Measures :
  1. Change in the Reinforcing Value of Food [ Time Frame: Baseline, 2-weeks, and 2-months ]
    Measured using a computer paradigm, the Behavioral Choice Task

  2. Change in activity [ Time Frame: Baseline, 2-week, and 2-month ]
    Physical and sedentary activities assessed using accelerometers and self-report

  3. Change in zBMI [ Time Frame: Baseline, 2-week, and 2-month ]
    Based on measured height and weight

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 8-11 years old
  • BMI for age and gender > 10th percentile (but no greater than 100% overweight)
  • Sleep 9.5 hours or less nightly
  • Attend elementary school
  • Like at least 1 food used in the reinforcement paradigm
  • Able to understand and complete the reinforcement paradigm

Exclusion Criteria:

  • Existence of a diagnosable parasomnia, sleep disordered breathing
  • Medical or psychiatric condition that could influence sleep or weight
  • Inability to complete study materials, including diagnosed disabilities
  • Dietary restrictions/allergies to foods used in the study that preclude them from study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01508793

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United States, Pennsylvania
Center for Obesity Research and Education
Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Temple University
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Principal Investigator: Chantelle N Hart, Ph.D. Temple University

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Responsible Party: The Miriam Hospital Identifier: NCT01508793     History of Changes
Other Study ID Numbers: R01HL092910 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: September 2015
Keywords provided by The Miriam Hospital:
Eating behaviors
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Signs and Symptoms