Status:
COMPLETED
Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief 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 hi...
Detailed Description
Assessment Procedures: Subjects will participate in 8 treatment sessions and 3 full assessment meetings over the course of 7 months. All meetings will be held at the Magnolia Park Sleep Disorders Cent...
Eligibility Criteria
Inclusion
- 6-12 years of age
- Prepubescent
- Have a body mass index ≥85th percentile for age and gender norms as published by the CDC, and
- Accompanied by a parent or legal guardian that lives in the same home as the child. The parent must be able to read and understand English at the 5th grade level.
Exclusion
- Sleep Apnea: previous diagnosis or an apnea/hypopnea index (AHI) \>10 according to PSG.
- Periodic Limb Movement Disorder (PLMD): previous diagnosis or myoclonus arousals per hour \>5 according to PSG.
- Circadian Rhythm Sleep Disorder, Delayed Sleep Phase Type
- Medication exclusions: Prescribed or OTC sleep medication within the last 1 month (unless stabilized on medication for 6+ months); Currently taking psychostimulants; antipsychotic agents; monoamine oxidase inhibitors; systemic corticosteroids; antibiotics for HIV or TB; chemotherapeutic drugs; or use of prescription weight-loss drugs within six months.
- Conditions or behaviors likely to affect trial conduct: unwilling to accept random assignment; participation in another randomized research project; parent unable to read and understand English at the 5th grade level; presence of bipolar or seizure disorder (potential sleep restriction); restless leg syndrome, major psychiatric disorder other than anxiety or depression; child with major cognitive or developmental delay; unable to complete forms, implement treatment procedures, etc. due to cognitive impairment; psychotropic or other medications (beta-blockers) known to alter sleep; participation in other CBT treatment or nonpharmacological sleep treatment; or any other condition/situation which would adversely affect trial participation.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2017
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02232217
Start Date
September 1 2014
End Date
September 30 2017
Last Update
May 11 2018
Active Locations (1)
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1
UF Health Shands
Gainesville, Florida, United States, 32606