<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/NCT02218138</url>
  </required_header>
  <id_info>
    <org_study_id>13-4265H</org_study_id>
    <secondary_id>R00HD069516</secondary_id>
    <nct_id>NCT02218138</nct_id>
  </id_info>
  <brief_title>Learning to BREATHE: A Randomized Controlled Trial to Lower Diabetes Risk in Adolescent Girls</brief_title>
  <official_title>Depression and Insulin Resistance in Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Colorado State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Type 2 diabetes is a chronic disease that puts people at risk for major health problems like&#xD;
      heart disease. Type 2 diabetes is the most common type of diabetes in adults. However, there&#xD;
      has been a concerning rise in type 2 diabetes among teenagers. Diabetes develops through poor&#xD;
      insulin sensitivity, meaning that insulin - an important chemical the body makes to keep&#xD;
      blood sugar normal - isn't working properly. Type 2 diabetes can be prevented by improving&#xD;
      insulin sensitivity. Stress is related to insulin sensitivity. Individuals who feel stressed&#xD;
      have worse insulin sensitivity than individuals who do not feel stressed. In adults,&#xD;
      decreasing stress leads to improvements in insulin sensitivity, but this hasn't been tested&#xD;
      in teenagers. The purpose of this study is to find out if taking part in a brief group&#xD;
      program to decrease stress will improve insulin sensitivity and lower diabetes risk in&#xD;
      teenage girls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After a screening to determine eligibility, girls are randomly assigned to take part in one&#xD;
      of two 6-week group programs: 1) Learning to BREATHE - a mindfulness-based program, or 2)&#xD;
      Colorado Blues - a cognitive-behavioral program. After the group, girls return for three&#xD;
      follow-up visits over the course of a year. The main outcomes are depressive symptoms and&#xD;
      insulin resistance. We also are assessing stress, eating behavior, fitness, and mindfulness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Homeostasis model assessment of insulin resistance</measure>
    <time_frame>1 year</time_frame>
    <description>Derived from fasting insulin and glucose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiological Studies-Depression Scale</measure>
    <time_frame>1 year</time_frame>
    <description>Total sum score reflecting a continuous measure of depressive symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Depression</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Learning 2 BREATHE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Learning 2 BREATHE, Mindfulness-based group program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colorado Blues</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Colorado Blues, Cognitive-behavioral depression prevention group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Learning 2 BREATHE</intervention_name>
    <description>Mindfulness-based group program</description>
    <arm_group_label>Learning 2 BREATHE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Colorado Blues</intervention_name>
    <description>Colorado Blues, Cognitive-behavioral depression prevention group</description>
    <arm_group_label>Colorado Blues</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 12-17 years&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Overweight or obese, defined as a body mass index (BMI; kg/m2) ≥ 85th percentile for&#xD;
             age&#xD;
&#xD;
          -  Family history of type 2 diabetes or pre-diabetes in 1st degree relative (e.g., parent&#xD;
             or sibling) or 2nd degree relative (e.g., aunt, uncle, or grandparent)&#xD;
&#xD;
          -  Elevated stress/symptoms of depression as indicated by a Center for Epidemiological&#xD;
             Studies-Depression Scale Total Score ≥ 16&#xD;
&#xD;
          -  Good general health as reported by adolescent and parent/guardian&#xD;
&#xD;
          -  English speaking (required for adolescent only, because the groups will be conducted&#xD;
             in English)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current psychiatric disorder such as major depressive disorder necessitating treatment&#xD;
&#xD;
          -  Type 2 diabetes as indicated by fasting glucose &gt; 126 mg/dL&#xD;
&#xD;
          -  Use of medication affecting insulin resistance, body weight, or mood such as&#xD;
             anti-depressants or stimulants&#xD;
&#xD;
          -  Current psychotherapy or weight loss treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lauren B Shomaker, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Colorado State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Colorado State University</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80523-1570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://awl.colostate.edu/</url>
    <description>Adolescent Wellness Lab Website</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Depression</keyword>
  <keyword>Obesity</keyword>
  <keyword>Stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02218138
org study id: 13-4265H
secondary id: R00HD069516
nct id: NCT02218138
lead sponsor: 
collaborator: 
has dmc: Yes
Type 2 diabetes is a chronic disease that puts people at risk for major health problems like
      heart disease. Type 2 diabetes is the most common type of diabetes in adults. However, there
      has been a concerning rise in type 2 diabetes among teenagers. Diabetes develops through poor
      insulin sensitivity, meaning that insulin - an important chemical the body makes to keep
      blood sugar normal - isn't working properly. Type 2 diabetes can be prevented by improving
      insulin sensitivity. Stress is related to insulin sensitivity. Individuals who feel stressed
      have worse insulin sensitivity than individuals who do not feel stressed. In adults,
      decreasing stress leads to improvements in insulin sensitivity, but this hasn't been tested
      in teenagers. The purpose of this study is to find out if taking part in a brief group
      program to decrease stress will improve insulin sensitivity and lower diabetes risk in
      teenage girls.
After a screening to determine eligibility, girls are randomly assigned to take part in one
      of two 6-week group programs: 1) Learning to BREATHE - a mindfulness-based program, or 2)
      Colorado Blues - a cognitive-behavioral program. After the group, girls return for three
      follow-up visits over the course of a year. The main outcomes are depressive symptoms and
      insulin resistance. We also are assessing stress, eating behavior, fitness, and mindfulness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Homeostasis model assessment of insulin resistance
time frame: 1 year
description: Derived from fasting insulin and glucose
measure: Center for Epidemiological Studies-Depression Scale
time frame: 1 year
description: Total sum score reflecting a continuous measure of depressive symptoms
arm group label: Learning 2 BREATHE
arm group type: Experimental
description: Learning 2 BREATHE, Mindfulness-based group program
arm group label: Colorado Blues
arm group type: Experimental
description: Colorado Blues, Cognitive-behavioral depression prevention group
intervention type: Behavioral
intervention name: Learning 2 BREATHE
description: Mindfulness-based group program
arm group label: Learning 2 BREATHE
intervention type: Behavioral
intervention name: Colorado Blues
description: Colorado Blues, Cognitive-behavioral depression prevention group
arm group label: Colorado Blues
criteria: 
gender: Female
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lauren B Shomaker, PhD
role: Principal Investigator
affiliation: Colorado State University
facility: 
country: United States
url: http://awl.colostate.edu/
description: Adolescent Wellness Lab Website
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No