xml: <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/NCT05993728</url>
    </required_header>
    <id_info>
      <org_study_id>609734</org_study_id>
      <nct_id>NCT05993728</nct_id>
    </id_info>
    <brief_title>Virtual Body Project Groups Led by Peers Versus Clinicians</brief_title>
    <acronym>v-BP</acronym>
    <official_title>Effectiveness of the Body Project to Prevent Eating Disorders in Young Females at Risk: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oslo University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Karolinska Institutet</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Oslo New University College, Norway</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Oslo University Hospital</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>
        Eating disorders (EDs) are a group of illnesses associated with significant psychological and&#xD;
        physiological consequences. Overall, only 20% of individuals with EDs receive treatment and&#xD;
        treatment is effective for only about 25-35% for those who receive care. The development and&#xD;
        implementation of effective prevention approaches for those at risk is therefore pivotal. The&#xD;
        Body Project is the most effective ED prevention program for at-risk females according to&#xD;
        meta-analyses, but reach has been limited since delivery has traditionally been in-person.&#xD;
        Further research is warranted to examine cost-effective and easily accessible approaches to&#xD;
        increase scalability and potential for broad implementation. With this application, the&#xD;
        investigators therefore propose to examine the effectiveness of the Body Project in young&#xD;
        females, a high-risk group, with the following main novel aspects: i) virtually-delivered&#xD;
        Body Project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered&#xD;
        Body Project groups; iii) the inclusion of objective measures to assess engagement of&#xD;
        intervention targets (i.e., mediator).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</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>Single (Investigator)</masking>
      <masking_description>The assessor completing the diagnostic interview will be blinded to the condition the participant is in (at all assessments)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change over time in eating disorder symptoms</measure>
      <time_frame>Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years</time_frame>
      <description>Assessed with the 28-item self-report Eating Disorder Examination Questionnaire (EDE-Q). Responses range from 0-6, whith higher scores indicating more severe eating disorder psychopathology</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of eating disorder onset</measure>
      <time_frame>Baseline/pretest, 1-year, and at 2-years</time_frame>
      <description>Assessed with the eating disorder diagnostic interview Eating Disorder Assessment-5 (EDA-5). This is a semi-structured clinician-led diagnostic interview, based on the diagnostic criteria in the diagnostic manual DSM-5, and is efficient to determine eating disorder diagnostic status. This outcome will be used to determine proportion of participants with an eating disorder diagnosis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change over time in Body dissatisfaction</measure>
      <time_frame>Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years</time_frame>
      <description>Assessed with the 10-item Body Dissatisfaction Scale (BDI; Berscheid et al., 2973) which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 5 = extremely satisfied. Lower scores indicate greater body dissatisfaction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change over time in thin-ideal internalization</measure>
      <time_frame>Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years</time_frame>
      <description>Assessed with the 8-item Ideal-Body Stereotype Scale-Revised (Stice et al., 2017) which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater belief in the thin-deal.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Negative affect</measure>
      <time_frame>Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years</time_frame>
      <description>20 negative items from the Positive and Negative Affect Schedule - Revised (PANAS-X) (Watson &amp; Clark, 1992) to measure negative affect. Higher scores indicate higher levels of negative affect. Responses range from 1-5</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change over time in appearance ideals and perceived pressures</measure>
      <time_frame>Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years</time_frame>
      <description>Assessed with the Attitudes Towards Appearance Questionnaire (SATAQ-4R) (Schaefer et al., 2017). A total of 31 items are included, and responses range from 1-5. Higher scores indicate higher levels of internalization/pressures</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">441</enrollment>
    <condition>Eating Disorders</condition>
    <condition>Body Image</condition>
    <arm_group>
      <arm_group_label>Clinician-led Body Project</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized to this condition will take part in virtual Body Project groups led by clinicians.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Peer-led Body Project</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized to this condition will take part in virtual Body Project groups led by peers.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Educational control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants randomized to the educational control group will receive educational videos on body image and eating disorders</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Body Project</intervention_name>
      <description>The Body Project prevention program is a body acceptance program to promote a healthy body image and prevent eating disorder onset.</description>
      <arm_group_label>Clinician-led Body Project</arm_group_label>
      <arm_group_label>Peer-led Body Project</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Psychoeducational control</intervention_name>
      <description>Participants randomized to the educational control condition will receive videos addressing body image and eating disorders</description>
      <arm_group_label>Educational control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 16-25&#xD;
  &#xD;
            -  Female identifying&#xD;
  &#xD;
            -  Self-reported body image concerns&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Ongoing eating disorder diagnosis requiring treatment or hospitalization&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female-identifying</gender_description>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Line Wisting, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Oslo University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Line Wisting, PhD</last_name>
      <phone>+4793495268</phone>
      <email>uxwili@ous-hf.no</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
      <investigator_full_name>Line Wisting</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Prevention</keyword>
    <keyword>Body acceptance</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>
  
  
text: 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/NCT05993728
  org study id: 609734
  nct id: NCT05993728
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Eating disorders (EDs) are a group of illnesses associated with significant psychological and
        physiological consequences. Overall, only 20% of individuals with EDs receive treatment and
        treatment is effective for only about 25-35% for those who receive care. The development and
        implementation of effective prevention approaches for those at risk is therefore pivotal. The
        Body Project is the most effective ED prevention program for at-risk females according to
        meta-analyses, but reach has been limited since delivery has traditionally been in-person.
        Further research is warranted to examine cost-effective and easily accessible approaches to
        increase scalability and potential for broad implementation. With this application, the
        investigators therefore propose to examine the effectiveness of the Body Project in young
        females, a high-risk group, with the following main novel aspects: i) virtually-delivered
        Body Project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered
        Body Project groups; iii) the inclusion of objective measures to assess engagement of
        intervention targets (i.e., mediator).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Investigator)
  masking description: The assessor completing the diagnostic interview will be blinded to the condition the participant is in (at all assessments)
  measure: Change over time in eating disorder symptoms
  time frame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
  description: Assessed with the 28-item self-report Eating Disorder Examination Questionnaire (EDE-Q). Responses range from 0-6, whith higher scores indicating more severe eating disorder psychopathology
  measure: Rate of eating disorder onset
  time frame: Baseline/pretest, 1-year, and at 2-years
  description: Assessed with the eating disorder diagnostic interview Eating Disorder Assessment-5 (EDA-5). This is a semi-structured clinician-led diagnostic interview, based on the diagnostic criteria in the diagnostic manual DSM-5, and is efficient to determine eating disorder diagnostic status. This outcome will be used to determine proportion of participants with an eating disorder diagnosis.
  measure: Change over time in Body dissatisfaction
  time frame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
  description: Assessed with the 10-item Body Dissatisfaction Scale (BDI; Berscheid et al., 2973) which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 5 = extremely satisfied. Lower scores indicate greater body dissatisfaction
  measure: Change over time in thin-ideal internalization
  time frame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
  description: Assessed with the 8-item Ideal-Body Stereotype Scale-Revised (Stice et al., 2017) which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater belief in the thin-deal.
  measure: Negative affect
  time frame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
  description: 20 negative items from the Positive and Negative Affect Schedule - Revised (PANAS-X) (Watson & Clark, 1992) to measure negative affect. Higher scores indicate higher levels of negative affect. Responses range from 1-5
  measure: Change over time in appearance ideals and perceived pressures
  time frame: Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years
  description: Assessed with the Attitudes Towards Appearance Questionnaire (SATAQ-4R) (Schaefer et al., 2017). A total of 31 items are included, and responses range from 1-5. Higher scores indicate higher levels of internalization/pressures
  arm group label: Clinician-led Body Project
  arm group type: Experimental
  description: Participants randomized to this condition will take part in virtual Body Project groups led by clinicians.
  arm group label: Peer-led Body Project
  arm group type: Experimental
  description: Participants randomized to this condition will take part in virtual Body Project groups led by peers.
  arm group label: Educational control
  arm group type: Active Comparator
  description: Participants randomized to the educational control group will receive educational videos on body image and eating disorders
  intervention type: Behavioral
  intervention name: Body Project
  description: The Body Project prevention program is a body acceptance program to promote a healthy body image and prevent eating disorder onset.
  arm group label: Clinician-led Body Project
  arm group label: Peer-led Body Project
  intervention type: Behavioral
  intervention name: Psychoeducational control
  description: Participants randomized to the educational control condition will receive videos addressing body image and eating disorders
  arm group label: Educational control
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female-identifying
  minimum age: 16 Years
  maximum age: 25 Years
  healthy volunteers: No
  last name: Line Wisting, PhD
  role: Principal Investigator
  affiliation: Oslo University Hospital
  last name: Line Wisting, PhD
  phone: +4793495268
  email: uxwili@ous-hf.no
  responsible party type: Principal Investigator
  investigator affiliation: Oslo University Hospital
  investigator full name: Line Wisting
  investigator title: Principal Investigator
  mesh term: Feeding and Eating Disorders
  sharing ipd: No