Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth

NCT ID: NCT02232217

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-09-30

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

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavior Therapy Sleep

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

Group Type: EXPERIMENTAL

Cognitive Behavior Therapy Sleep

Intervention Type: BEHAVIORAL

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

Education Control

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.

Group Type: ACTIVE_COMPARATOR

Education Control

Intervention Type: OTHER

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.

Interventions

Cognitive Behavior Therapy Sleep

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: BEHAVIORAL

Education Control

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: OTHER

Other Intervention Names

CBTcs; EC

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David M Janicke, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Christina McCrae, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health Shands

Gainesville, Florida, United States

Countries

United States

Other Identifiers

R21HL121432

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH NHLBI [pending]

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201400307-N

Identifier Type: -

Identifier Source: org_study_id