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Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth

Primary Purpose

Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy Sleep
Education Control
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep focused on measuring Children, Sleep, Obesity

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • UF Health Shands

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavior Therapy Sleep

Education Control

Arm Description

Children in this arm will receive instructions on the use of 'coping thoughts.' Common elements across the CBTcs sessions include reviewing progress, setting goals for change, problem solving to address challenges/barriers, and reinforcing progress

Children in this arm will receive sleep and dietary education, as well as general coping strategies and controls for staff attention and seasonal effects that could influence changes in sleep and health outcomes.

Outcomes

Primary Outcome Measures

Total Sleep Time

Secondary Outcome Measures

time spent in physical activity
caloric intake

Full Information

First Posted
September 2, 2014
Last Updated
May 10, 2018
Sponsor
University of Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02232217
Brief Title
Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth
Official Title
Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
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 Center. The following procedures will be performed: Stage 1 - Phone Screening, Stage 2 - Screening and Baseline Measures, Stage 3 - Overnight Sleep Monitoring, Stage 4 - Two weeks Wrist Actigraphy, Sleep Diaries, Dietary Recalls Stage 5 - Intervention, Stage 6 - Post-Treatment Measures, Stage 7 - 3-Month Follow-Up

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep
Keywords
Children, Sleep, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavior Therapy Sleep
Arm Type
Experimental
Arm Description
Children in this arm will receive instructions on the use of 'coping thoughts.' Common elements across the CBTcs sessions include reviewing progress, setting goals for change, problem solving to address challenges/barriers, and reinforcing progress
Arm Title
Education Control
Arm Type
Active Comparator
Arm Description
Children in this arm will receive sleep and dietary education, as well as general coping strategies and controls for staff attention and seasonal effects that could influence changes in sleep and health outcomes.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy Sleep
Other Intervention Name(s)
CBTcs
Intervention Description
Children in this arm will receive instructions on the use of 'coping thoughts.' Common elements across the CBTcs sessions include reviewing progress, setting goals for change, problem solving to address challenges/barriers, and reinforcing progress
Intervention Type
Other
Intervention Name(s)
Education Control
Other Intervention Name(s)
EC
Intervention Description
Children in this arm will receive sleep and dietary education, as well as general coping strategies and controls for staff attention and seasonal effects that could influence changes in sleep and health outcomes.
Primary Outcome Measure Information:
Title
Total Sleep Time
Time Frame
change from baseline to 2 months
Secondary Outcome Measure Information:
Title
time spent in physical activity
Time Frame
change from baseline to 2 months
Title
caloric intake
Time Frame
change from baseline to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Janicke, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christina McCrae, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Shands
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States

12. IPD Sharing Statement

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Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth

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