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Evaluating Body Acceptance Programs for Young Men

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ClinicalTrials.gov Identifier: NCT04687228
Recruitment Status : Recruiting
First Posted : December 29, 2020
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
Michael and Arlene Rosen Foundation
Information provided by (Responsible Party):
Tiffany Brown, University of California, San Diego

Brief Summary:
While eating disorders in males are often overlooked, up to 7 million men in the United States will experience an Eating Disorder in their lifetime. Critically, men are less likely to seek treatment for an Eating Disorder compared to females. Therefore, prevention programs that target male-specific Eating Disorder risk factors prior to the development of an eating or appearance-related disorder are crucial in reducing eating disorders in this population. Preliminary work by our group established the initial efficacy of a novel program, the Body Project: More than Muscles (MTM) compared to assessment-only control. This study will replicate and extend this research by comparing MTM to a time and attention-matched control used in previous eating disorder prevention work, media advocacy (MA).

Condition or disease Intervention/treatment Phase
Body Image Disturbance Eating Disorder Symptom Dysmorphia Eating Disorders Behavioral: More than Muscles (MTM) Behavioral: Media Advocacy (MA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will briefly be screened for eligibility criteria by phone. Eligible participants will be assessed using two structured clinical interviews (SCID-5 & EPSI-CRV) and complete a set of self-report measures at baseline. Following assessment participants will be randomized into one of two groups. One group will receive a dissonance-based intervention known as the More than Muscles (MTM), while other participants will engage in a Media Advocacy (MA) active control. Participants will complete the same set of self-report measures from baseline, after their final group, at 1-month follow-up and at 6-month follow-up. During the 6-month follow-up participants will also be reassessed using the same structured clinical interviews at baseline.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Participants will remain unaware of what group they have been randomized to as both groups will be actively be participating in groups focused on male body image.
Primary Purpose: Prevention
Official Title: Evaluating Body Acceptance Programs for Young Men
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Active Comparator: Media Advocacy (MA)
Participants assigned to this condition take place in a time and attention-matched active control where they discuss the role of media in promoting the body ideal.
Behavioral: Media Advocacy (MA)
MA content generally centers on acknowledging and discussing the role the media has on shaping body image ideals. Session 1: In session 1, similar to MTM, the primary activities will include: (1) describing the ideal body for men in our culture, (2) discussing how the media impacts this ideal, with a particular focus on advertising. Following this, participants will (3) watch a video on how the media influences body image among men, and the consequences of internalizing these messages. Session 2: In session 2, content will continue by further discussion of the video showed in session 1, with participants sharing their reactions. Next, the group discusses the attainability of the ideal as well as discusses other forms of media (e.g., social media) and how it impacts body image.

Experimental: Body Project: More than Muscles (MTM)
Participants assigned to this condition take part in a two-session intervention based on dissonance theory which encourages them to challenge the body ideal.
Behavioral: More than Muscles (MTM)
In session 1, the primary activities are: 1) define the "ideal" body type for men in our culture, 2) discuss the origin and perpetration of the "ideal," 3) brainstorm the costs of pursuing the "ideal," 4) participate in a verbal challenge during which participants counter the "ideal" message, and (5) are asked to complete three "homework" assignments (i.e., a letter to an adolescent boy, a behavioral challenge, and a mirror exposure assignment). In session 2, the primary activities are: 1) reviewing homework, 2) engage in role-plays to counter/discourage pursuit of the "ideal," 3) discuss ways to challenge and avoid "negative body talk" statements, 4) list ways to resist the pressure to pursue this "ideal" both individually and as a group within the larger community (i.e., body activism), 5) discuss barriers to body activism and strategies to overcome those barriers, and 6) individually select an exit exercise to continue to actively challenge the appearance ideal.
Other Name: Body Project




Primary Outcome Measures :
  1. Eating Disorder Examination Questionnaire (EDE-Q) [ Time Frame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up ]
    The EDE-Q is a 28-item measure scored on a 7-point rating scale with scores ranging from 0 to 168 (scores higher than 4 on individual questions are indicative of clinical levels). The EDE-Q is a transdiagnostic measure of Eating Disorder symptoms with high scores indicating elevated eating pathology.

  2. Muscle Dysmorphic Disorder Inventory (MDDI) [ Time Frame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up ]
    The MDDI is a 13-item measure for muscle dysmorphia symptoms, which is a common feature of Eating Disorders in men. Items are scored 0 (never) to 4 (always) with higher scores indicating greater muscle dysmorphic symptoms. Scores on this measure range 0 to 52.

  3. Eating Pathology Symptom Inventory-Clinician Rated Version (EPSI-CRV) [ Time Frame: Change from baseline to 6-month follow-up related to dimensional changes in Eating Disorder-related psychopathology. ]
    The EPSI-CRV is a semi-structured interview that assesses dimensional constructs of psychopathology associated with Diagnostic and Statistical Manual-5 Eating Disorders. The interview will take approximately 40 minutes to complete.


Secondary Outcome Measures :
  1. Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ) [ Time Frame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up ]
    The SATAQ is a 30-item measure of westernized beauty standards represented in media. Items are rated 1 (definitely disagree) to 5 (definitely agree) with scores ranging from 30 to 150. Higher scores indicate greater endorsement of beauty ideals portrayed in the media.

  2. Drive for Muscularity Scale (DMS) [ Time Frame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up ]
    The DMS is a 15-item measure of self-perceived muscularity. The measure utilizes a 6 point scale, (1) indicating always, and (6) denoting never. Lower scores indicate higher drive for muscularity. Scores range from 16 to 90 on the DMS.

  3. Male Body Attitudes Scale (MBAS) [ Time Frame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up ]
    The MBAS is a 29-item dimensional assessment of men's body attitudes. Items are scored from 1 (never) to 6 (always) with higher scores reflecting elevated negative body attitudes. Scores from this measure range from 29 to 174.

  4. Self-Objectification Questionnaire (SOQ) [ Time Frame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up ]
    The SOQ is a 20-item measure of how individuals appraise attributes in reference to themselves and their partner. Half of the questions relate to personal attributes the other half relate to a potential partners. The measure requires participants to rank the ten questions related to their personal attributes from 0 (least impact) to 9 (highest impact) and repeat the procedure for a potential partner.

  5. Obligatory Exercise Questionnaire (OEQ) [ Time Frame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up ]
    The OEQ is a 20-item measure of maladaptive exercise, a common feature in Eating Disorders. Responses are captured using a 4-point scale, 1 (never) to 4 (always), with higher scores indicating increased dysregulation relating to exercise. Scores range from 20 to 80 for this measure.

  6. Appearance and Performance Enhancing Drug Use (APED; questions were derived from the Adolescents Training and Learning to Avoid Steroids [ATLAS] study) [ Time Frame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up ]
    APED use was measured using 8-items derived from the ATLAS study. Participants are asked to respond from 1 (strongly agree) to 7 (strongly disagree) on the first 5 questions. Higher scores indicate elevated risk for future steroid use. The final 3-items request participants indicate if they have used anabolic steroids in the past 3 months (yes or no); if they have used supplements to alter their physical appearance (yes or no); if they answered yes to using supplements to alter their physical appearance, they were asked to endorse what specific substance was used (e.g., protein powder, creatine, testosterone booster, and fat burners).

  7. Depression, Anxiety, Stress Scale (DASS-21) [ Time Frame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up ]
    The DASS-21 is a 21-item measure that examines symptoms related to stress, anxiety, and depression. Participants are asked for respond on a scale from 0 (doesn't apply to me at all) to 3 (applies to me very much, or most of the time). Higher scores on the three sub-scales indicate elevated symptoms associated with depression, anxiety, or stress. Total scores range from 0 to 63. Each sub-scale is scored from 0 to 21.

  8. Difficulties in Emotion Regulation Scale (DERS) short form [ Time Frame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up ]
    The DERS-16 is a validated brief version of the original DERS (36-item measure). The brief version of the DERS, is a 16-item measure for dimensions of emotion dysregulation. Participants indicate how often each statement applies to them on a scale from 1 (almost never) to 5 (almost always). Scores for the measure range from 16 to 80, with higher scores indicating greater emotion regulation difficulty.

  9. Acceptance and Action Questionnaire 2 (AAQ-II) [ Time Frame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up ]
    The AAQ-II is a 7-item measure of experiential avoidance and psychological flexibility. Participants use a 7-point scale ranging from 1 (never true) to 7 (always true) in response to each statement. Scores range from 7 to 49, with higher scores indicating greater psychological inflexibility and avoidance of emotional experiences.

  10. Intervention Acceptability [ Time Frame: Immediately post-intervention ]
    Participants will respond to a 13-item measure of intervention acceptability for the MTM condition and MA condition. The first 10-items are scored on a 5 point scale, 1 indicating strongly disagree and 5 indicating strongly agree (higher score indicating higher acceptability). The last 3-items request participants provide written feedback about the intervention they participated in: which part of the program was most helpful? Which activity was the least helpful? Do you have any suggestions for improving the program? The last 3-items are not scored or included in the overall treatment acceptability score.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Person who self-identify as male.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 30 years old
  • Identify as male
  • Endorse body image concerns
  • Speak English and able to provide informed consent

Exclusion Criteria:

  • Diagnosis of a DSM-5 eating disorder determined by SCID-5
  • Significant neuropsychiatric illness (e.g., dementia, untreated severe psychiatric illness determined by SCID-unmedicated bipolar disorder, psychosis, or active suicidal ideation)
  • Older than 30 years old
  • Younger than 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04687228


Contacts
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Contact: Tiffany A Brown, PhD 858-534-8019 tiffanybrown@health.ucsd.edu
Contact: Dominic M Denning, BA 858-534-8019 dmdenning@health.ucsd.edu

Locations
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United States, California
University of California, San Diego, Eating Disorder Center for Treatment and Research Recruiting
San Diego, California, United States, 92093
Contact: Tiffany A Brown, PhD    858-534-8019    tiffanybrown@health.ucsd.edu   
Contact: Dominic M Denning, BA    858-255-4371    dmdenning@health.ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Michael and Arlene Rosen Foundation
Additional Information:
Publications:
Keel PK. Eating Disorders. Upper Saddle River: Prentice Hall; 2005
Jones W, Morgan J. Eating disorders in men: A review of the literature. Journal of Public Mental Health. 2010;9(2):23-31.
Bramon-Bosch E, Troop NA, Treasure JL. Eating disorders in males: a comparison with female patients. European Eating Disorders Review. 2000;8(4):321-328.
Pope H, Phillips KA, Olivardia R. The Adonis complex: The secret crisis of male body obsession: Simon and Schuster; 2000.
Harrison K, Cantor J. The relationship between media consumption and eating disorders. Journal of communication. 1997;47(1):40-67.
Becker CB, Smith LM, Ciao AC. Peer-facilitated eating disorder prevention: A randomized effectiveness trial of cognitive dissonance and media advocacy. Journal of Counseling Psychology. 2006;53(4):550.

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Responsible Party: Tiffany Brown, Principal Investigator & Assistant Project Scientist at the Eating Disorder Center for Treatment and Research, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04687228    
Other Study ID Numbers: 201229S
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Principal Investigator will comply with data storage and sharing guidelines associated with her institutions best practices. Participant information will be de-identified in cases of sharing to maintain anonymity.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tiffany Brown, University of California, San Diego:
Male
Muscularity Oriented Eating
Exercise
Eating Disorder
Body Image
Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders