Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth

NCT02232217 | Completed DMC

• 3 other identifiers: IRB201400307-NR21HL121432NIH NHLBI [pending]
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

Children; Sleep; Obesity

Outcome Measures

Primary Outcomes (1)

• Total Sleep Time

  change from baseline to 2 months

Secondary Outcomes (2)

• time spent in physical activity

  change from baseline to 2 months

• caloric intake

  change from baseline to 2 months

Study Arms (2)

Cognitive Behavior Therapy Sleep

EXPERIMENTAL

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

Behavioral: Cognitive Behavior Therapy Sleep

Education Control

ACTIVE COMPARATOR

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.

Other: Education Control

Interventions

Cognitive Behavior Therapy Sleep 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

Also known as: CBTcs

Cognitive Behavior Therapy Sleep

Education Control 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.

Also known as: EC

Education Control

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UF Health Shands

Gainesville, Florida, 32606, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David M Janicke, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Christina McCrae, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 5, 2014
• Study Start: September 1, 2014
• Primary Completion: August 30, 2017
• Study Completion: September 30, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)