<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02232217</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201400307-N</org_study_id>
    <secondary_id>R21HL121432</secondary_id>
    <secondary_id>NIH NHLBI [pending]</secondary_id>
    <nct_id>NCT02232217</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth</brief_title>
  <official_title>Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to conduct a randomized controlled trial (RCT) to evaluate the&#xD;
      efficacy of brief cognitive behavioral treatment for child sleep (CBTcs) to improve sleep in&#xD;
      an important high-risk population, overweight/obese (OV/OB) youth with behavioral sleep&#xD;
      disorders. OV/OB youth with behavioral sleep disorders and their parent(s) will be randomly&#xD;
      assigned to 8 sessions of either CBTcs or an Educational Control (EC). CBTcs will address&#xD;
      behavioral sleep issues in children; EC will address sleep and dietary education and general&#xD;
      coping strategies. Child sleep (total wake time, total sleep time, bed/wake times), height,&#xD;
      weight, physical activity, dietary intake, quality of life (QOL), fatigue, and daytime&#xD;
      sleepiness will be assessed at baseline, post-treatment, and 3-month follow-up. It is&#xD;
      hypothesized the children in the CBTcs will experience greater improvement in sleep than&#xD;
      children in the EC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assessment Procedures: Subjects will participate in 8 treatment sessions and 3 full&#xD;
      assessment meetings over the course of 7 months. All meetings will be held at the Magnolia&#xD;
      Park Sleep Disorders Center. The following procedures will be performed:&#xD;
&#xD;
      Stage 1 - Phone Screening, Stage 2 - Screening and Baseline Measures, Stage 3 - Overnight&#xD;
      Sleep Monitoring, Stage 4 - Two weeks Wrist Actigraphy, Sleep Diaries, Dietary Recalls Stage&#xD;
      5 - Intervention, Stage 6 - Post-Treatment Measures, Stage 7 - 3-Month Follow-Up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">August 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Sleep Time</measure>
    <time_frame>change from baseline to 2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>time spent in physical activity</measure>
    <time_frame>change from baseline to 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>caloric intake</measure>
    <time_frame>change from baseline to 2 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavior Therapy Sleep</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavior Therapy Sleep</intervention_name>
    <description>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</description>
    <arm_group_label>Cognitive Behavior Therapy Sleep</arm_group_label>
    <other_name>CBTcs</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education Control</intervention_name>
    <description>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.</description>
    <arm_group_label>Education Control</arm_group_label>
    <other_name>EC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  6-12 years of age&#xD;
&#xD;
          -  Prepubescent&#xD;
&#xD;
          -  Have a body mass index ≥85th percentile for age and gender norms as published by the&#xD;
             CDC, and&#xD;
&#xD;
          -  Accompanied by a parent or legal guardian that lives in the same home as the child.&#xD;
             The parent must be able to read and understand English at the 5th grade level.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sleep Apnea: previous diagnosis or an apnea/hypopnea index (AHI) &gt;10 according to PSG.&#xD;
&#xD;
          -  Periodic Limb Movement Disorder (PLMD): previous diagnosis or myoclonus arousals per&#xD;
             hour &gt;5 according to PSG.&#xD;
&#xD;
          -  Circadian Rhythm Sleep Disorder, Delayed Sleep Phase Type&#xD;
&#xD;
          -  Medication exclusions: Prescribed or OTC sleep medication within the last 1 month&#xD;
             (unless stabilized on medication for 6+ months); Currently taking psychostimulants;&#xD;
             antipsychotic agents; monoamine oxidase inhibitors; systemic corticosteroids;&#xD;
             antibiotics for HIV or TB; chemotherapeutic drugs; or use of prescription weight-loss&#xD;
             drugs within six months.&#xD;
&#xD;
          -  Conditions or behaviors likely to affect trial conduct: unwilling to accept random&#xD;
             assignment; participation in another randomized research project; parent unable to&#xD;
             read and understand English at the 5th grade level; presence of bipolar or seizure&#xD;
             disorder (potential sleep restriction); restless leg syndrome, major psychiatric&#xD;
             disorder other than anxiety or depression; child with major cognitive or developmental&#xD;
             delay; unable to complete forms, implement treatment procedures, etc. due to cognitive&#xD;
             impairment; psychotropic or other medications (beta-blockers) known to alter sleep;&#xD;
             participation in other CBT treatment or nonpharmacological sleep treatment; or any&#xD;
             other condition/situation which would adversely affect trial participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David M Janicke, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christina McCrae, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF Health Shands</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>May 10, 2018</last_update_submitted>
  <last_update_submitted_qc>May 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>Sleep</keyword>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02232217
org study id: IRB201400307-N
secondary id: R21HL121432
secondary id: NIH NHLBI [pending]
nct id: NCT02232217
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Total Sleep Time
time frame: change from baseline to 2 months
measure: time spent in physical activity
time frame: change from baseline to 2 months
measure: caloric intake
time frame: change from baseline to 2 months
arm group label: Cognitive Behavior Therapy Sleep
arm group type: Experimental
description: 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
arm group label: Education Control
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Cognitive Behavior Therapy Sleep
description: 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
arm group label: Cognitive Behavior Therapy Sleep
other name: CBTcs
intervention type: Other
intervention name: Education Control
description: 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.
arm group label: Education Control
other name: EC
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: David M Janicke, PhD
role: Principal Investigator
affiliation: University of Florida
last name: Christina McCrae, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight