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NCT02232217 · ClinicalTrials.gov registry record · NA

Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth

A NA study of Sleep, sponsored by University of Florida.

Completed
Registry status
NA
Development phase
54
Enrollment target
1
Study location

NCT02232217 is a NA study of Sleep that has completed, run by University of Florida. The registered enrollment target is 54 participants, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02232217, a NA study of Sleep, has completed, sponsored by University of Florida.

COMPLETED
Registry status
NA
Development phase
54 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to conduct a randomized controlled trial (RCT) to evaluate the efficacy of brief cognitive behavioral treatment for child sleep (CBTcs) to improve sleep in an important high-risk population, overweight/obese (OV/OB) youth with behavioral sleep disorders. OV/OB youth with behavioral sleep disorders and their parent(s) will be randomly assigned to 8 sessions of either CBTcs or an Educational Control (EC). CBTcs will address behavioral sleep issues in children; EC will address sleep and dietary education and general coping strategies. Child sleep (total wake time, total sleep time, bed/wake times), height, weight, physical activity, dietary intake, quality of life (QOL), fatigue, and daytime sleepiness will be assessed at baseline, post-treatment, and 3-month follow-up. It is hypothesized the children in the CBTcs will experience greater improvement in sleep than children in the EC.

Conditions Studied

Interventions

  • OTHER Education Control
  • BEHAVIORAL Cognitive Behavior Therapy Sleep

Study Locations (1)

Florida

  • UF Health Shands - Gainesville

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2014-09
Est. Completion 2017-09-30
Phase NA

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT02232217

The ClinicalTrials.gov registry entry for NCT02232217 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (99% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sleep appearing as the primary indexed condition, and to 2 interventions - of which Education Control is the first listed.

NCT02232217 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT02232217 about?

NCT02232217 is a clinical study titled "Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth". The purpose of this study is to conduct a randomized controlled trial (RCT) to evaluate the efficacy of brief cognitive behavioral treatment for child sleep (CBTcs) to improve sleep in an important high-risk population, overweight/obese (OV/OB) youth with behavioral sleep disorders. OV/OB youth with...

What is the current status of trial NCT02232217?

This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2014-09. Estimated completion is 2017-09-30.

What conditions does trial NCT02232217 study?

This clinical trial studies the following conditions: Sleep.

What interventions are being tested in trial NCT02232217?

The interventions under investigation include: Education Control (OTHER), Cognitive Behavior Therapy Sleep (BEHAVIORAL).

Who is sponsoring clinical trial NCT02232217?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02232217 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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