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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by The Miriam Hospital
Sponsor:
Collaborator:
Temple University
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01508793
First received: January 5, 2012
Last updated: April 18, 2014
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: November 2015
Estimated Primary Completion Date: November 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
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: NCT01508793

Contacts
Contact: Chantelle Hart, Ph.D. 215-707-8639 chantelle.hart@temple.edu
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
Temple University
Investigators
Principal Investigator: Chantelle N Hart, Ph.D. Temple 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: April 18, 2014
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 July 29, 2014