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

January 5, 2021 updated by: The Miriam Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

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

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Center for Obesity Research and Education
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • The Miriam Hospital

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

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep Duration
Time Frame: Baseline, 2-weeks, and 2-months
Measured with actigraphy
Baseline, 2-weeks, and 2-months
Change in Dietary Intake
Time Frame: Baseline, 2-weeks, and 2-months
Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)
Baseline, 2-weeks, and 2-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Reinforcing Value of Food
Time Frame: Baseline, 2-weeks, and 2-months
Measured using a computer paradigm, the Behavioral Choice Task
Baseline, 2-weeks, and 2-months
Change in activity
Time Frame: Baseline, 2-week, and 2-month
Physical and sedentary activities assessed using accelerometers and self-report
Baseline, 2-week, and 2-month
Change in zBMI
Time Frame: Baseline, 2-week, and 2-month
Based on measured height and weight
Baseline, 2-week, and 2-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

Temple University

Investigators

  • Principal Investigator: Chantelle N Hart, Ph.D., Temple University

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

January 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HL092910 (U.S. NIH Grant/Contract)

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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