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

NCT ID: NCT01508793

Last Updated: 2021-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-11-30

Brief Summary

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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

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Conditions

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Sleep Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Optimize Sleep

Group Type EXPERIMENTAL

Optimize Sleep

Intervention Type BEHAVIORAL

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

Interventions

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Optimize Sleep

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Temple University

OTHER

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chantelle N Hart, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Center for Obesity Research and Education

Philadelphia, Pennsylvania, United States

Site Status

The Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL092910

Identifier Type: NIH

Identifier Source: org_study_id

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