<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/NCT03262350</url>
  </required_header>
  <id_info>
    <org_study_id>REF AWARD# 0001271422</org_study_id>
    <nct_id>NCT03262350</nct_id>
  </id_info>
  <brief_title>The Effects of Yoga on Body Image in College Women</brief_title>
  <official_title>Can Yoga Reduce Body Image Concerns in Females, Thereby Reducing Risk of Obesity and Eating Disorders?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Delaware</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Emily Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Neuropsychiatric Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Delaware</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effects of a regular yoga practice on body image&#xD;
      in college women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled design will be used to study the effects of a regular yoga practice&#xD;
      on body image in young adult women. Fifty female freshman, sophomores, and juniors between&#xD;
      the ages of 18 and 26 years will be recruited from the University of Delaware student&#xD;
      population, specifically targeting those new to yoga. Age, academic standing, availability&#xD;
      and prior yoga experience will be evaluated.&#xD;
&#xD;
      Consented individuals will be randomized to one of two conditions: (1) yoga (offered 3 times&#xD;
      per week) for 10 weeks; or (2) a control group. Baseline assessments, midpoint assessments,&#xD;
      and end-of-study assessments will be conducted on all participants. Participants will be&#xD;
      compensated for their attendance at assessment visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">June 1, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Image</measure>
    <time_frame>10 weeks</time_frame>
    <description>assessed using Body Image Quality of Life Inventory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body image</measure>
    <time_frame>10 weeks</time_frame>
    <description>assessed using Mind Body Self Relations Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in Body Mass Index</measure>
    <time_frame>10 weeks</time_frame>
    <description>weight and height will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disordered eating attitudes/behaviors</measure>
    <time_frame>10 weeks</time_frame>
    <description>assessed using the Eating Attitudes Test-26</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disordered eating attitudes/behaviors</measure>
    <time_frame>10 weeks</time_frame>
    <description>assessed using the Binge Eating Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Body Image</condition>
  <condition>Eating Disorder</condition>
  <condition>Obesity</condition>
  <condition>Yoga</condition>
  <arm_group>
    <arm_group_label>Yoga Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are required to attend three assessment visits. During these assessments, participants will complete a questionnaire that will ask about their eating patterns, body image, sleep habits, and loneliness and have their height and weight measured. Participants are also required to attend 50-minute yoga classes on Mondays, Wednesdays, and Fridays from 1:25-2:15pm for 10 weeks. The overall time commitment for Yoga Group participants is 3 hours of assessments and 50-minute yoga classes 3X week for 10 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be required to attend three assessment visits. During these assessments, participants will complete a questionnaire that will ask about their eating patterns, health habits, body image, sleep habits and loneliness and have their height and weight measured. The overall time commitment for Control Group participants is 3 hours of assessments total.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>The yoga classes will be adapted to all levels of experience, mobility, and body size. Specific breathing techniques and body positive language will be incorporated into a body-positive yoga training done by Ms. Lisa Diers, RDN, E-RYT, YACEP. Less focus will be placed on precision of the poses, instead focus will be on body feelings, except where physically dangerous. Thus, the overall focus will be on listening to one's own body. List of messages will be carefully designed to be related to eating and weight, but to not be directly discussed. Ms. Diers will travel to Delaware to lead the intervention training for yoga instructors prior to the study taking place.</description>
    <arm_group_label>Yoga Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Freshman, sophomore, or junior at the University of Delaware&#xD;
&#xD;
          -  Available Spring 2017 on Mondays, Wednesdays, and Fridays from 1:25-2:15pm&#xD;
&#xD;
          -  Physically able to participate in yoga&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females who are seniors at the University of Delaware (This is because participants in&#xD;
             the control condition will be given a pass to participate in group fitness at the end&#xD;
             of the study, and would not be able to use this incentive if they are seniors)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Delaware</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>May 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Delaware</investigator_affiliation>
    <investigator_full_name>Carly R Pacanowski</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Feeding and Eating Disorders</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/NCT03262350
org study id: REF AWARD# 0001271422
nct id: NCT03262350
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the effects of a regular yoga practice on body image
      in college women.
A randomized controlled design will be used to study the effects of a regular yoga practice
      on body image in young adult women. Fifty female freshman, sophomores, and juniors between
      the ages of 18 and 26 years will be recruited from the University of Delaware student
      population, specifically targeting those new to yoga. Age, academic standing, availability
      and prior yoga experience will be evaluated.

      Consented individuals will be randomized to one of two conditions: (1) yoga (offered 3 times
      per week) for 10 weeks; or (2) a control group. Baseline assessments, midpoint assessments,
      and end-of-study assessments will be conducted on all participants. Participants will be
      compensated for their attendance at assessment visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Body Image
time frame: 10 weeks
description: assessed using Body Image Quality of Life Inventory
measure: body image
time frame: 10 weeks
description: assessed using Mind Body Self Relations Questionnaire
measure: change in Body Mass Index
time frame: 10 weeks
description: weight and height will be combined to report BMI in kg/m^2
measure: disordered eating attitudes/behaviors
time frame: 10 weeks
description: assessed using the Eating Attitudes Test-26
measure: disordered eating attitudes/behaviors
time frame: 10 weeks
description: assessed using the Binge Eating Scale
arm group label: Yoga Group
arm group type: Experimental
description: Participants are required to attend three assessment visits. During these assessments, participants will complete a questionnaire that will ask about their eating patterns, body image, sleep habits, and loneliness and have their height and weight measured. Participants are also required to attend 50-minute yoga classes on Mondays, Wednesdays, and Fridays from 1:25-2:15pm for 10 weeks. The overall time commitment for Yoga Group participants is 3 hours of assessments and 50-minute yoga classes 3X week for 10 weeks.
arm group label: Control Group
arm group type: No Intervention
description: Participants will be required to attend three assessment visits. During these assessments, participants will complete a questionnaire that will ask about their eating patterns, health habits, body image, sleep habits and loneliness and have their height and weight measured. The overall time commitment for Control Group participants is 3 hours of assessments total.
intervention type: Behavioral
intervention name: Yoga
description: The yoga classes will be adapted to all levels of experience, mobility, and body size. Specific breathing techniques and body positive language will be incorporated into a body-positive yoga training done by Ms. Lisa Diers, RDN, E-RYT, YACEP. Less focus will be placed on precision of the poses, instead focus will be on body feelings, except where physically dangerous. Thus, the overall focus will be on listening to one's own body. List of messages will be carefully designed to be related to eating and weight, but to not be directly discussed. Ms. Diers will travel to Delaware to lead the intervention training for yoga instructors prior to the study taking place.
arm group label: Yoga Group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Delaware
investigator full name: Carly R Pacanowski
investigator title: Assistant Professor
mesh term: Obesity
mesh term: Feeding and Eating Disorders
sharing ipd: No