Clinical trial NCT02232217: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Children
Sleep
Obesity
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-09-05
Enrollment: 54
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Total Sleep Time
timeFrame: change from baseline to 2 months
Secondary outcomes:
measure: time spent in physical activity
timeFrame: change from baseline to 2 months
measure: caloric intake
timeFrame: change from baseline to 2 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Shands
state: Florida
Study officials:
affiliation: University of Florida
name: David M Janicke, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Christina McCrae, PhD
role: PRINCIPAL_INVESTIGATOR
References: