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

Not Applicable

Completed

• Conditions: Obesity; Sleep
• Interventions: Behavioral: Optimize Sleep

• Registration Number: NCT01508793
• Lead Sponsor: The Miriam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Primary Completion: 2016-06
• Study Completion: 2016-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimize Sleep	Optimize Sleep	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Center for Obesity Research and Education; 🇺🇸 Philadelphia, Pennsylvania, United States

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States