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

Status Completed

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Overweight
• Sleep

• NCT number: NCT02232217
• Study type: Interventional
• Source: University of Florida
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Completion date: September 30, 2017