Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 12 |
| Updated: | 5/13/2018 |
| Start Date: | September 2014 |
| End Date: | September 30, 2017 |
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.
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.
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
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
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.
We found this trial at
1
site
Gainesville, Florida 32606
Principal Investigator: David M Janicke, PhD
Phone: 352-273-6046
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