<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/NCT03758326</url>
  </required_header>
  <id_info>
    <org_study_id>2018-001-01</org_study_id>
    <nct_id>NCT03758326</nct_id>
  </id_info>
  <brief_title>A New Measure of Body Image in Eating Disorders</brief_title>
  <official_title>Measurement of Body Image in Eating Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laureate Institute for Brain Research, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laureate Institute for Brain Research, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aims to compare a new electronic instrument called (here referred to as the 'Body&#xD;
      App') with traditional paper and pencil rating scales for assessing how individuals with&#xD;
      eating disorders evaluate their body image.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Self-perceived weight or shape disturbance is a core symptom of eating disorders, with heavy&#xD;
      therapeutic and prognostic relevance. Developing a reliable and unbiased method to assess&#xD;
      body image disturbance is imperative, as feature characteristics of eating disorders, such as&#xD;
      anorexia nervosa, include the overestimation of body size and shape. Among the most essential&#xD;
      features of the disorder, this inability to correctly judge one's own body image has been&#xD;
      frequently linked to the maintenance of eating disorders. Moreover, persistent perceptual&#xD;
      disturbance for one's visual appearance is one of the strong predictors of relapse in AN and&#xD;
      bulimia nervosa.&#xD;
&#xD;
      Body image disturbance can be conceptualized as having two main components: perceptual, and&#xD;
      attitudinal/affective. These might be considered two distinct constructs, best measured&#xD;
      independently. However, clinicians currently rely upon self-report questionnaires that&#xD;
      evaluate aggregates of symptoms, perceptual experiences, behaviors, and thoughts linked to&#xD;
      the disorder. Some scales selectively evaluate body image characteristics such as body&#xD;
      dissatisfaction and body distortion. However, it is unclear to what degree each of these&#xD;
      measures quantifies the specific components of perceptual experiences vs.&#xD;
      attitudinal/affective aspects. This study aims to evaluate whether a new electronic&#xD;
      instrument, here referred to as the 'Body App', which separates estimations of body shape and&#xD;
      size from the attitudinal/affective component might result in closer approximations of the&#xD;
      perceptual component of weight or shape disturbance, and facilitate the assessment of body&#xD;
      image disturbance in eating disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 16, 2018</start_date>
  <completion_date type="Anticipated">March 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body image distortion score on the Body App Tool</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Discrepancy between subjective body estimation on avatar and actual measurement of corresponding body part</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body image dissatisfaction score on the Photographic Figure Rating Scale</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Average of the absolute change in body image dissatisfaction across each measurement (score range: 0 to 10; larger changes indicate greater severity of body image dissatisfaction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body image disturbance on the Body Appreciation Scale-2</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Average of the absolute change in body image disturbance across each measurement relative to baseline (range 10 to 50, higher scores indicating reduced severity of body image disturbance)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eating disorder severity on the Eating Disorder Examination Questionnaire</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Average of the absolute change in overall eating disorder severity across each measurement relative to baseline (range 0 to 6, larger scores indicate greater severity of eating disorder)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body image disturbance on the Body Image States Scale</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Average of the absolute change in body image disturbance across each measurement relative to baseline (range 0 to 48, higher scores indicate greater severity of body image disturbance)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body dysmorphic concerns on the Dysmorphic Concerns Questionnaire</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Average of the absolute change in dysmorphic concerns across each measurement relative to baseline (range 0 to 21, higher scores indicate greater severity of dysmorphic concerns)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise addiction on the Exercise Addiction Inventory</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Average of the absolute change in exercise addiction across each measurement relative to baseline (range 6 to 30, higher scores indicate greater severity of exercise addiction)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Eating Disorder</condition>
  <arm_group>
    <arm_group_label>Eating disorder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Measurement of body image via Body App and relationship to body measurement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy comparison</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Measurement of body image via Body App and relationship to body measurement</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Body App</intervention_name>
    <description>Participants will indicate areas of concern on a virtual manikin using an electronic online interface. Body measurements will also be collected.</description>
    <arm_group_label>Eating disorder</arm_group_label>
    <arm_group_label>Healthy comparison</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eating disorders group:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary clinical diagnosis of eating disorder&#xD;
&#xD;
          -  Receiving inpatient treatment for eating disorder&#xD;
&#xD;
          -  Body mass index greater than or equal to 14&#xD;
&#xD;
          -  Independently ambulatory&#xD;
&#xD;
          -  Possession of a smartphone with data plan&#xD;
&#xD;
          -  English proficiency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active suicidal ideation&#xD;
&#xD;
          -  Comorbid schizophrenia spectrum or other psychotic disorder.&#xD;
&#xD;
        Healthy comparison group:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  No current psychiatric diagnosis&#xD;
&#xD;
          -  Body mass index greater than or equal to 14&#xD;
&#xD;
          -  Independently ambulatory&#xD;
&#xD;
          -  Possession of a smartphone with data plan&#xD;
&#xD;
          -  English proficiency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index &gt; 41&#xD;
&#xD;
          -  Active suicidal ideation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Eligibility is based on self-representation of gender identity.</gender_description>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sahib Khalsa, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laureate Institute for Brain Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laureate Institute for Brain Research</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>March 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>June 28, 2022</last_update_submitted>
  <last_update_submitted_qc>June 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Body image</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03758326
org study id: 2018-001-01
nct id: NCT03758326
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to compare a new electronic instrument called (here referred to as the 'Body
      App') with traditional paper and pencil rating scales for assessing how individuals with
      eating disorders evaluate their body image.
Self-perceived weight or shape disturbance is a core symptom of eating disorders, with heavy
      therapeutic and prognostic relevance. Developing a reliable and unbiased method to assess
      body image disturbance is imperative, as feature characteristics of eating disorders, such as
      anorexia nervosa, include the overestimation of body size and shape. Among the most essential
      features of the disorder, this inability to correctly judge one's own body image has been
      frequently linked to the maintenance of eating disorders. Moreover, persistent perceptual
      disturbance for one's visual appearance is one of the strong predictors of relapse in AN and
      bulimia nervosa.

      Body image disturbance can be conceptualized as having two main components: perceptual, and
      attitudinal/affective. These might be considered two distinct constructs, best measured
      independently. However, clinicians currently rely upon self-report questionnaires that
      evaluate aggregates of symptoms, perceptual experiences, behaviors, and thoughts linked to
      the disorder. Some scales selectively evaluate body image characteristics such as body
      dissatisfaction and body distortion. However, it is unclear to what degree each of these
      measures quantifies the specific components of perceptual experiences vs.
      attitudinal/affective aspects. This study aims to evaluate whether a new electronic
      instrument, here referred to as the 'Body App', which separates estimations of body shape and
      size from the attitudinal/affective component might result in closer approximations of the
      perceptual component of weight or shape disturbance, and facilitate the assessment of body
      image disturbance in eating disorders.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Body image distortion score on the Body App Tool
time frame: Through study completion, an average of 1 year
description: Discrepancy between subjective body estimation on avatar and actual measurement of corresponding body part
measure: Body image dissatisfaction score on the Photographic Figure Rating Scale
time frame: Through study completion, an average of 1 year
description: Average of the absolute change in body image dissatisfaction across each measurement (score range: 0 to 10; larger changes indicate greater severity of body image dissatisfaction)
measure: Body image disturbance on the Body Appreciation Scale-2
time frame: Through study completion, an average of 1 year
description: Average of the absolute change in body image disturbance across each measurement relative to baseline (range 10 to 50, higher scores indicating reduced severity of body image disturbance)
measure: Eating disorder severity on the Eating Disorder Examination Questionnaire
time frame: Through study completion, an average of 1 year
description: Average of the absolute change in overall eating disorder severity across each measurement relative to baseline (range 0 to 6, larger scores indicate greater severity of eating disorder)
measure: Body image disturbance on the Body Image States Scale
time frame: Through study completion, an average of 1 year
description: Average of the absolute change in body image disturbance across each measurement relative to baseline (range 0 to 48, higher scores indicate greater severity of body image disturbance)
measure: Body dysmorphic concerns on the Dysmorphic Concerns Questionnaire
time frame: Through study completion, an average of 1 year
description: Average of the absolute change in dysmorphic concerns across each measurement relative to baseline (range 0 to 21, higher scores indicate greater severity of dysmorphic concerns)
measure: Exercise addiction on the Exercise Addiction Inventory
time frame: Through study completion, an average of 1 year
description: Average of the absolute change in exercise addiction across each measurement relative to baseline (range 6 to 30, higher scores indicate greater severity of exercise addiction)
arm group label: Eating disorder
arm group type: Other
description: Measurement of body image via Body App and relationship to body measurement
arm group label: Healthy comparison
arm group type: Other
description: Measurement of body image via Body App and relationship to body measurement
intervention type: Other
intervention name: Body App
description: Participants will indicate areas of concern on a virtual manikin using an electronic online interface. Body measurements will also be collected.
arm group label: Eating disorder
arm group label: Healthy comparison
criteria: 
gender: Female
gender based: Yes
gender description: Eligibility is based on self-representation of gender identity.
minimum age: 13 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sahib Khalsa, MD, PhD
role: Principal Investigator
affiliation: Laureate Institute for Brain Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Feeding and Eating Disorders
sharing ipd: No