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

This study is currently recruiting participants.
Verified January 2012 by The Miriam Hospital
Sponsor:
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01508793
First received: January 5, 2012
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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 Intervention
Sleep
Obesity
Behavioral: Optimize Sleep

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Change in Sleep Duration [ Time Frame: Baseline, 2-weeks, and 2-months ] [ Designated as safety issue: No ]
    Measured with actigraphy

  • Change in Dietary Intake [ Time Frame: Baseline, 2-weeks, and 2-months ] [ Designated as safety issue: No ]
    Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)


Secondary Outcome Measures:
  • Change in the Reinforcing Value of Food [ Time Frame: Baseline, 2-weeks, and 2-months ] [ Designated as safety issue: No ]
    Measured using a computer paradigm, the Behavioral Choice Task

  • Change in activity [ Time Frame: Baseline, 2-week, and 2-month ] [ Designated as safety issue: No ]
    Physical and sedentary activities assessed using accelerometers and self-report

  • Change in zBMI [ Time Frame: Baseline, 2-week, and 2-month ] [ Designated as safety issue: No ]
    Based on measured height and weight


Estimated Enrollment: 104
Study Start Date: August 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508793

Contacts
Contact: Chantelle Hart, Ph.D. 401-793-9727 chart@lifespan.org
Contact: Nicola Hawley, Ph.D. 401-793-8931 nhawley@lifespan.org

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

Additional Information:
No publications provided

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01508793     History of Changes
Other Study ID Numbers: R01HL092910
Study First Received: January 5, 2012
Last Updated: January 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Sleep
Obesity
Children
Eating behaviors
Activity

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

ClinicalTrials.gov processed this record on April 17, 2014