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

Sponsor

The Miriam Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01508793

Collaborator

Temple University (Other)

103

Enrollment

Locations

Arms

Duration (Months)

51.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Sleep Duration [Baseline, 2-weeks, and 2-months]
Measured with actigraphy
Change in Dietary Intake [Baseline, 2-weeks, and 2-months]
Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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