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Clinical Trials/NCT01508793
NCT01508793
Completed
Not Applicable

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

The Miriam Hospital2 sites in 1 country103 target enrollmentJanuary 2012
ConditionsSleepObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep
Sponsor
The Miriam Hospital
Enrollment
103
Locations
2
Primary Endpoint
Change in Sleep Duration
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
November 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Change in Sleep Duration

Time Frame: Baseline, 2-weeks, and 2-months

Measured with actigraphy

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 Outcomes

  • Change in zBMI(Baseline, 2-week, and 2-month)
  • Change in activity(Baseline, 2-week, and 2-month)
  • Change in the Reinforcing Value of Food(Baseline, 2-weeks, and 2-months)

Study Sites (2)

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