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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508793
• Other study ID #: R01HL092910
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: November 2016

Study information

• Verified date: January 2021
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Sleep

Intervention

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

Locations

Country	Name	City	State
United States	Center for Obesity Research and Education	Philadelphia	Pennsylvania
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sleep Duration	Measured with actigraphy	Baseline, 2-weeks, and 2-months
Primary	Change in Dietary Intake	Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)	Baseline, 2-weeks, and 2-months
Secondary	Change in the Reinforcing Value of Food	Measured using a computer paradigm, the Behavioral Choice Task	Baseline, 2-weeks, and 2-months
Secondary	Change in activity	Physical and sedentary activities assessed using accelerometers and self-report	Baseline, 2-week, and 2-month
Secondary	Change in zBMI	Based on measured height and weight	Baseline, 2-week, and 2-month