<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/NCT03013244</url>
  </required_header>
  <id_info>
    <org_study_id>2015.17069</org_study_id>
    <nct_id>NCT03013244</nct_id>
  </id_info>
  <brief_title>Reducing Eating Disorder Risk Factors Among College-Aged Males</brief_title>
  <official_title>A Randomized Controlled Trial of The Body Project: More Than Muscles for Males With Body Dissatisfaction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida State University</source>
  <brief_summary>
    <textblock>
      The purpose of the present study was to investigate the acceptability and efficacy of a&#xD;
      cognitive dissonance-based (DB) intervention in reducing eating disorder and muscle&#xD;
      dysmorphia risk factors in men with body dissatisfaction. The investigators hypothesized that&#xD;
      the program would reduce eating disorder risk factors to a greater degree compared to wait&#xD;
      list control and that these effects would be maintained at 1 month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND &amp; PURPOSE The current project sought to examine the acceptability and efficacy of&#xD;
      a cognitive dissonance-based (DB) eating disorder prevention program for college-aged men&#xD;
      with body image concerns. Eating disorders represent a public health problem for which&#xD;
      efficacious, disseminable treatments largely remain unknown, particularly for males.&#xD;
      Epidemiological data support the increasing prevalence of eating disorders and body image&#xD;
      concerns among men; however, few programs have been developed to address concerns relevant to&#xD;
      men, and many men feel uncomfortable in programs that identify eating disorders as a &quot;female&quot;&#xD;
      problem. Given that eating disorders are particularly difficult to treat, disseminable&#xD;
      interventions that can target high-risk groups prior to eating disorder onset may be the best&#xD;
      way to reduce the public health burden associated with eating disorders. As body image&#xD;
      concerns represent the most potent and consistent risk factor for developing eating disorders&#xD;
      in males and females, men with body image concerns represent one such high-risk, but&#xD;
      underserved, group.&#xD;
&#xD;
      Recent prevention research has used DB principles to challenge thin-ideal internalization to&#xD;
      decrease the likelihood of developing an eating disorder in female youth. Additionally, the&#xD;
      investigators recently adapted and evaluated a DB program for gay males (The PRIDE Body&#xD;
      Project), who represent another high-risk group among men. Dissonance theory states that when&#xD;
      individuals engage in counter-attitudinal behavior they experience psychological discomfort,&#xD;
      leading them to alter their attitudes to be congruent with their behavior. Several studies&#xD;
      have supported the efficacy of DB programs in reducing eating disorder risk among females and&#xD;
      results from The PRIDE Body Project extends the efficacy of these programs to gay males.&#xD;
      These DB interventions have utilized peer co-leaders, capitalizing on the importance of peer&#xD;
      influences on eating behaviors among college-aged females and males.&#xD;
&#xD;
      To date, other than The PRIDE Body Project, no studies have examined eating disorder&#xD;
      prevention interventions for high-risk groups of males. Notably, the success of The PRIDE&#xD;
      Body Project and several lines of research support that adapting a DB program may also be&#xD;
      helpful in reducing eating disorder risk among young men with body image concerns. First,&#xD;
      internalization of the mesomorphic ideal plays a central role in risk for developing eating&#xD;
      pathology in males. Thus, an intervention targeting internalization of this body ideal may be&#xD;
      particularly helpful for males. Second, studies support that peers influence body&#xD;
      dissatisfaction and disordered eating in males concurrently and prospectively through&#xD;
      socialization. This suggests that men, regardless of sexual orientation, may benefit from a&#xD;
      peer-led DB program to address body image concerns. This work could fill a critical gap in&#xD;
      the care provided to a growing demographic among those who suffer from eating disorders.&#xD;
&#xD;
      Thus, the aim of the present study was to determine the acceptability and efficacy of&#xD;
      adapting a cognitive DB intervention for use in college-aged men with body image concerns.&#xD;
      112 men with body image concerns were recruited to participate in a randomized controlled&#xD;
      trial (RCT), in which they were randomized into either a DB intervention (n=52) or wait list&#xD;
      control (WL) condition (n=60).&#xD;
&#xD;
      The investigators hypothesized that: (1) The men in the DB group would show significantly&#xD;
      greater reductions on all measures compared to men in the WL group; and (2) Differences&#xD;
      between groups would be maintained at 4-week follow-up.&#xD;
&#xD;
      DESIGN Participants Participants (n=112) were recruited through introductory and upper&#xD;
      division psychology classes at Florida State University (FSU), through the psychology&#xD;
      research participant pool, and advertisements around the campus and local community. Based on&#xD;
      retention rates in The PRIDE Body Project, the investigators estimated a 75% retention rate.&#xD;
      Analyses support that the expected sample size should provide sufficient power to detect&#xD;
      group differences, based on effect sizes from previous DB studies.&#xD;
&#xD;
      Procedure All participants first completed an eligibility phone screen to determine whether&#xD;
      they met study eligibility criteria. Participants who qualified for and were interested in&#xD;
      participating in the study were directed to complete the online consent form.&#xD;
&#xD;
      This intervention was adapted from a two-session DB intervention that the investigators&#xD;
      developed for gay men, which was originally adapted for women to address risk factors&#xD;
      specific to males with body image concerns, regardless of sexual orientation. Participants&#xD;
      completed baseline measures assessing eating disorder and muscle dysmorphia risk factors,&#xD;
      which were selected based on demonstrated reliability and validity in previous studies,&#xD;
      particularly for use in men.&#xD;
&#xD;
      The two, 2-hour intervention sessions were spaced one week apart. Intervention groups&#xD;
      included 4-10 members each and took place at the FSU psychology building. The investigator&#xD;
      and an undergraduate peer co-leader facilitated all intervention groups. During Session 1,&#xD;
      participants: (a) defined the male &quot;body-ideal&quot;, (b) discussed the origin/perpetuation of the&#xD;
      &quot;body-ideal&quot;, (c) brainstormed costs of pursuing the &quot;ideal&quot;, (d) participated in verbal&#xD;
      challenges countering the &quot;body-ideal&quot; message, and (e) were assigned homework assignments.&#xD;
      In Session 2 participants: (a) reviewed homework, (b) engaged in role plays to counter&#xD;
      pursuit of the &quot;body-ideal&quot; (c) discussed ways to challenge and avoid negative &quot;body talk&quot;&#xD;
      (d) listed ways to resist pressures to pursue this ideal both individually and at the&#xD;
      university level (termed &quot;body activism&quot;) and (e) selected an exit exercise to practice&#xD;
      positive body talk. All intervention sessions were audiotaped to ensure facilitator adherence&#xD;
      to the protocol.&#xD;
&#xD;
      Baseline measures were repeated for both conditions immediately post-intervention/after a&#xD;
      one-week interval and 4-weeks post-intervention/after a five-week interval, to assess&#xD;
      immediate and longer-term effects.&#xD;
&#xD;
      Data Analytic Plan The data analytic approach utilized hierarchical linear modeling (HLM), to&#xD;
      control for repeated assessments of participants nested within groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eating Disorder Examination Questionnaire - Bulimic Symptoms Composite</measure>
    <time_frame>change from baseline to post-intervention (1 week)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Sociocultural Attitudes Towards Appearance Questionnaire-3 - Internalization General subscale</measure>
    <time_frame>change from baseline to post-intervention (1 week)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Eating Disorder Examination-Questionnaire Restraint Subscale</measure>
    <time_frame>change from baseline to post-intervention (1 week)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Male Body Attitudes Scale</measure>
    <time_frame>change from baseline to post-intervention (1 week)</time_frame>
    <description>The investigators examined the Muscularity and Body Fat subscales for this study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Drive for Muscularity Scale</measure>
    <time_frame>change from baseline to post-intervention (1 week)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Dysmorphia Disorder Inventory</measure>
    <time_frame>change from baseline to post-intervention (1 week)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating Disorder Examination Questionnaire - Bulimic Symptoms Composite</measure>
    <time_frame>change from baseline to follow-up (5 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sociocultural Attitudes Towards Appearance Questionnaire-3 - Internalization General subscale</measure>
    <time_frame>change from baseline to follow-up (5 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eating Disorder Examination-Questionnaire Restraint Subscale</measure>
    <time_frame>change from baseline to follow-up (5 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Male Body Attitudes Scale</measure>
    <time_frame>change from baseline to follow-up (5 weeks)</time_frame>
    <description>The investigators examined the Muscularity and Body Fat subscales for this study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drive for Muscularity Scale</measure>
    <time_frame>change from baseline to follow-up (5 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Dysmorphia Disorder Inventory</measure>
    <time_frame>change from baseline to follow-up (5 weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Eating Disorder</condition>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this condition completed assessments at baseline, 1 week, and 5 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The Body Project: More Than Muscles</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition competed the 2-session dissonance-based eating disorder prevention protocol (2 hours per session).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Body Project: More Than Muscles</intervention_name>
    <description>Participants complete a variety of activities designed to counter internalization of the lean, muscular body ideal for men.</description>
    <arm_group_label>The Body Project: More Than Muscles</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  do not meet criteria for an eating disorder (based on phone screen interview)&#xD;
&#xD;
          -  endorse body image concerns&#xD;
&#xD;
          -  18 years -30 years&#xD;
&#xD;
          -  agree to participate in a positive body image program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals under 18 years of age&#xD;
&#xD;
          -  Individuals who do not meet criterion a, b, c, or d (as outlined in the inclusion&#xD;
             criteria)&#xD;
&#xD;
          -  Individuals who meet full criteria for an eating disorder based on responses on the&#xD;
             phone screen&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pamela K Keel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Florida State University</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prevention</keyword>
  <keyword>eating disorder</keyword>
  <keyword>men</keyword>
  <keyword>intervention</keyword>
  <keyword>muscle dysmorphia</keyword>
  <keyword>peer-led</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/NCT03013244
org study id: 2015.17069
nct id: NCT03013244
lead sponsor: 
The purpose of the present study was to investigate the acceptability and efficacy of a
      cognitive dissonance-based (DB) intervention in reducing eating disorder and muscle
      dysmorphia risk factors in men with body dissatisfaction. The investigators hypothesized that
      the program would reduce eating disorder risk factors to a greater degree compared to wait
      list control and that these effects would be maintained at 1 month follow-up.
BACKGROUND & PURPOSE The current project sought to examine the acceptability and efficacy of
      a cognitive dissonance-based (DB) eating disorder prevention program for college-aged men
      with body image concerns. Eating disorders represent a public health problem for which
      efficacious, disseminable treatments largely remain unknown, particularly for males.
      Epidemiological data support the increasing prevalence of eating disorders and body image
      concerns among men; however, few programs have been developed to address concerns relevant to
      men, and many men feel uncomfortable in programs that identify eating disorders as a "female"
      problem. Given that eating disorders are particularly difficult to treat, disseminable
      interventions that can target high-risk groups prior to eating disorder onset may be the best
      way to reduce the public health burden associated with eating disorders. As body image
      concerns represent the most potent and consistent risk factor for developing eating disorders
      in males and females, men with body image concerns represent one such high-risk, but
      underserved, group.

      Recent prevention research has used DB principles to challenge thin-ideal internalization to
      decrease the likelihood of developing an eating disorder in female youth. Additionally, the
      investigators recently adapted and evaluated a DB program for gay males (The PRIDE Body
      Project), who represent another high-risk group among men. Dissonance theory states that when
      individuals engage in counter-attitudinal behavior they experience psychological discomfort,
      leading them to alter their attitudes to be congruent with their behavior. Several studies
      have supported the efficacy of DB programs in reducing eating disorder risk among females and
      results from The PRIDE Body Project extends the efficacy of these programs to gay males.
      These DB interventions have utilized peer co-leaders, capitalizing on the importance of peer
      influences on eating behaviors among college-aged females and males.

      To date, other than The PRIDE Body Project, no studies have examined eating disorder
      prevention interventions for high-risk groups of males. Notably, the success of The PRIDE
      Body Project and several lines of research support that adapting a DB program may also be
      helpful in reducing eating disorder risk among young men with body image concerns. First,
      internalization of the mesomorphic ideal plays a central role in risk for developing eating
      pathology in males. Thus, an intervention targeting internalization of this body ideal may be
      particularly helpful for males. Second, studies support that peers influence body
      dissatisfaction and disordered eating in males concurrently and prospectively through
      socialization. This suggests that men, regardless of sexual orientation, may benefit from a
      peer-led DB program to address body image concerns. This work could fill a critical gap in
      the care provided to a growing demographic among those who suffer from eating disorders.

      Thus, the aim of the present study was to determine the acceptability and efficacy of
      adapting a cognitive DB intervention for use in college-aged men with body image concerns.
      112 men with body image concerns were recruited to participate in a randomized controlled
      trial (RCT), in which they were randomized into either a DB intervention (n=52) or wait list
      control (WL) condition (n=60).

      The investigators hypothesized that: (1) The men in the DB group would show significantly
      greater reductions on all measures compared to men in the WL group; and (2) Differences
      between groups would be maintained at 4-week follow-up.

      DESIGN Participants Participants (n=112) were recruited through introductory and upper
      division psychology classes at Florida State University (FSU), through the psychology
      research participant pool, and advertisements around the campus and local community. Based on
      retention rates in The PRIDE Body Project, the investigators estimated a 75% retention rate.
      Analyses support that the expected sample size should provide sufficient power to detect
      group differences, based on effect sizes from previous DB studies.

      Procedure All participants first completed an eligibility phone screen to determine whether
      they met study eligibility criteria. Participants who qualified for and were interested in
      participating in the study were directed to complete the online consent form.

      This intervention was adapted from a two-session DB intervention that the investigators
      developed for gay men, which was originally adapted for women to address risk factors
      specific to males with body image concerns, regardless of sexual orientation. Participants
      completed baseline measures assessing eating disorder and muscle dysmorphia risk factors,
      which were selected based on demonstrated reliability and validity in previous studies,
      particularly for use in men.

      The two, 2-hour intervention sessions were spaced one week apart. Intervention groups
      included 4-10 members each and took place at the FSU psychology building. The investigator
      and an undergraduate peer co-leader facilitated all intervention groups. During Session 1,
      participants: (a) defined the male "body-ideal", (b) discussed the origin/perpetuation of the
      "body-ideal", (c) brainstormed costs of pursuing the "ideal", (d) participated in verbal
      challenges countering the "body-ideal" message, and (e) were assigned homework assignments.
      In Session 2 participants: (a) reviewed homework, (b) engaged in role plays to counter
      pursuit of the "body-ideal" (c) discussed ways to challenge and avoid negative "body talk"
      (d) listed ways to resist pressures to pursue this ideal both individually and at the
      university level (termed "body activism") and (e) selected an exit exercise to practice
      positive body talk. All intervention sessions were audiotaped to ensure facilitator adherence
      to the protocol.

      Baseline measures were repeated for both conditions immediately post-intervention/after a
      one-week interval and 4-weeks post-intervention/after a five-week interval, to assess
      immediate and longer-term effects.

      Data Analytic Plan The data analytic approach utilized hierarchical linear modeling (HLM), to
      control for repeated assessments of participants nested within groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Eating Disorder Examination Questionnaire - Bulimic Symptoms Composite
time frame: change from baseline to post-intervention (1 week)
measure: Sociocultural Attitudes Towards Appearance Questionnaire-3 - Internalization General subscale
time frame: change from baseline to post-intervention (1 week)
measure: Eating Disorder Examination-Questionnaire Restraint Subscale
time frame: change from baseline to post-intervention (1 week)
measure: Male Body Attitudes Scale
time frame: change from baseline to post-intervention (1 week)
description: The investigators examined the Muscularity and Body Fat subscales for this study
measure: Drive for Muscularity Scale
time frame: change from baseline to post-intervention (1 week)
measure: Muscle Dysmorphia Disorder Inventory
time frame: change from baseline to post-intervention (1 week)
measure: Eating Disorder Examination Questionnaire - Bulimic Symptoms Composite
time frame: change from baseline to follow-up (5 weeks)
measure: Sociocultural Attitudes Towards Appearance Questionnaire-3 - Internalization General subscale
time frame: change from baseline to follow-up (5 weeks)
measure: Eating Disorder Examination-Questionnaire Restraint Subscale
time frame: change from baseline to follow-up (5 weeks)
measure: Male Body Attitudes Scale
time frame: change from baseline to follow-up (5 weeks)
description: The investigators examined the Muscularity and Body Fat subscales for this study
measure: Drive for Muscularity Scale
time frame: change from baseline to follow-up (5 weeks)
measure: Muscle Dysmorphia Disorder Inventory
time frame: change from baseline to follow-up (5 weeks)
arm group label: Waitlist Control
arm group type: No Intervention
description: Participants in this condition completed assessments at baseline, 1 week, and 5 weeks.
arm group label: The Body Project: More Than Muscles
arm group type: Experimental
description: Participants in this condition competed the 2-session dissonance-based eating disorder prevention protocol (2 hours per session).
intervention type: Behavioral
intervention name: The Body Project: More Than Muscles
description: Participants complete a variety of activities designed to counter internalization of the lean, muscular body ideal for men.
arm group label: The Body Project: More Than Muscles
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Pamela K Keel, PhD
role: Principal Investigator
affiliation: Florida State University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Feeding and Eating Disorders
sharing ipd: No