<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/NCT02191995</url>
  </required_header>
  <id_info>
    <org_study_id>1405S51026</org_study_id>
    <nct_id>NCT02191995</nct_id>
  </id_info>
  <brief_title>Yoga in the Treatment of Eating Disorders: a Randomized Trial</brief_title>
  <acronym>TEP</acronym>
  <official_title>Yoga in the Treatment of Eating Disorders: a Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Yoga facilitates the treatment of eating disorders by decreasing symptom severity over time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants' level of mood and anxiety</measure>
    <time_frame>Week 4</time_frame>
    <description>The Positive And Negative Affect Scale will be administered daily prior to and after supper in order to assess anxiety and mood.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of eating disorder symptoms</measure>
    <time_frame>Week 4</time_frame>
    <description>The Eating Disorder Examination-Questionnaire will be administered to evaluate clients' eating disorder symptoms and prevalence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' ability to tolerance distress</measure>
    <time_frame>Week 4</time_frame>
    <description>The Distress Tolerance Scale will be administered to follow clients' ability to cope with highly charged emotions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Anorexia Nervosa</condition>
  <condition>Bulimia Nervosa</condition>
  <arm_group>
    <arm_group_label>body awareness yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>body awareness yoga session prior to breakfast meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>yoga</intervention_name>
    <arm_group_label>body awareness yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admitted to the Anna Westin House treatment facility of the Emily Program in MN during&#xD;
             timeframe study is being run&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  declines participation in study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dianne Neumark-Sztainer, PhD MPH RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carol Peterson, PhD LP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Scott Crow, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Diers, RD LD RYT</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Emily Program</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Emily Program</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>May 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
    <mesh_term>Anorexia Nervosa</mesh_term>
    <mesh_term>Bulimia Nervosa</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/NCT02191995
org study id: 1405S51026
nct id: NCT02191995
lead sponsor: 
has dmc: No
Yoga facilitates the treatment of eating disorders by decreasing symptom severity over time.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Participants' level of mood and anxiety
time frame: Week 4
description: The Positive And Negative Affect Scale will be administered daily prior to and after supper in order to assess anxiety and mood.
measure: Level of eating disorder symptoms
time frame: Week 4
description: The Eating Disorder Examination-Questionnaire will be administered to evaluate clients' eating disorder symptoms and prevalence.
measure: Participants' ability to tolerance distress
time frame: Week 4
description: The Distress Tolerance Scale will be administered to follow clients' ability to cope with highly charged emotions.
arm group label: body awareness yoga
arm group type: Experimental
description: body awareness yoga session prior to breakfast meal
arm group label: Control Arm
arm group type: No Intervention
description: No intervention
intervention type: Behavioral
intervention name: yoga
arm group label: body awareness yoga
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dianne Neumark-Sztainer, PhD MPH RD
role: Principal Investigator
affiliation: University of Minnesota
last name: Carol Peterson, PhD LP
role: Principal Investigator
affiliation: University of Minnesota
last name: Scott Crow, MD
role: Principal Investigator
affiliation: University of Minnesota
last name: Lisa Diers, RD LD RYT
role: Principal Investigator
affiliation: The Emily Program
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Bulimia
mesh term: Feeding and Eating Disorders
mesh term: Anorexia Nervosa
mesh term: Bulimia Nervosa