Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02232217
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2014-09-02
Brief Title:
Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 overweightobese OVOB youth with behavioral sleep disorders OVOB youth with behavioral sleep disorders and their parents 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 bedwake 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21HL121432 | NIH | None | None |
| NIH NHLBI pending | OTHER | R21HD11680545 | httpsreporternihgovquickSearchR21HL121432 |