Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth

Sleep Clinical Trial

Official title:

Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232217
• Other study ID #: IRB201400307-N
• Secondary ID: R21HL121432NIH N
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 30, 2017

Study information

• Verified date: May 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Sleep

Intervention

Behavioral:
• 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

Other:
• 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.

Locations

Country	Name	City	State
United States	UF Health Shands	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Sleep Time		change from baseline to 2 months
Secondary	time spent in physical activity		change from baseline to 2 months
Secondary	caloric intake		change from baseline to 2 months