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

NCT01508793 | Completed DMC

• 1 other identifier: R01HL092910
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep; Obesity

Keywords

Sleep; Obesity; Children; Eating behaviors; Activity

Outcome Measures

Primary Outcomes (2)

• Change in Sleep Duration

  Measured with actigraphy

  Baseline, 2-weeks, and 2-months

• Change in Dietary Intake

  Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)

  Baseline, 2-weeks, and 2-months

Secondary Outcomes (3)

• Change in the Reinforcing Value of Food

  Baseline, 2-weeks, and 2-months

• Change in activity

  Baseline, 2-week, and 2-month

• Change in zBMI

  Baseline, 2-week, and 2-month

Study Arms (2)

Control

NO INTERVENTION

Optimize Sleep

EXPERIMENTAL

Behavioral: Optimize Sleep

Interventions

Optimize Sleep BEHAVIORAL

Children are asked to increase their sleep by approximately 1 1/2 hours/night for the duration of the two month intervention

Optimize Sleep

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• Temple University: collaborator

Study Sites (2)

Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19140, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Obesity; Feeding Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Chantelle N Hart, Ph.D.

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 12, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

US (2)