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The Pride Body Project (PBP)

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ClinicalTrials.gov Identifier: NCT03451513
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Aaron Blashill, San Diego State University

Brief Summary:
The purpose of this study is to better investigate the efficacy of the PRIDE Body Project in respect to preventing eating disorders in sexual minority men. In this randomized controlled trial, participants will be enrolled in one of two arms: 1) the PRIDE Body Project intervention or 2) Media Advocacy, a time and attention-matched intervention. This study will recruit participants who are between the ages of 18 and 30, identify as men, are gay, bisexual, or experience sexual attraction to men, and who express body image concerns for the San Diego area.

Condition or disease Intervention/treatment Phase
Eating Disorder Body Image Behavioral: Pride Body Project Behavioral: Media Advocacy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: On a phone screen, participants will be orally consented, and assessed briefly for eligibility. Participants who seem eligible will come in for an assessment made up of self- and clinician-report assessments, where they will be consented and assessed for eligibility. Eligible participants will be randomized. All participants completed intervention as determined by randomized assignment (i.e., MA or PBP). Each subject ID is pre-assigned to a study condition, determined by an online randomization program, prior to recruitment. Each eligible participant had a 1/2 chance to be assigned to either of the two study conditions. Participants will take part in two intervention sessions spaced a week apart. 1 to 2 weeks after the last session, participants will complete a follow-up, where they will do self- and clinician-report assessments. Further follow-up assessments, also comprised of both self- and clinician report assessments will be completed 6, 12, 18, and 24 months after treatment.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The investigator will not be told which condition individual participants are in. Outcome assessors at follow-up will not be told which condition the participant was in; any assessments regarding the content of intervention will be done by a separate, unblind assessor. The research assistants who enter the data from the clinician-based assessments administered by the outcome assessors will also be blind to participant condition assignment.
Primary Purpose: Prevention
Official Title: A Brief, Peer Co-led, Group-based Eating Disorder Prevention Program for Sexual Minority Young Adult Men
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pride Body Project (PBP)
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: Pride Body Project
PBP is a 2-session eating disorder prevention program. Each session is 2 hours, and separated by a week. Groups have 4 to 7 participants and are led by a peer and a clinician. This program allows a forum for young men to critique the appearance ideal. These exercises should induce cognitive dissonance, which subsequently lead to a reduction of internalization of the ideal. In session 1, participants: (1) define the "ideal" body type in the gay community, (2) discuss its origin and perpetration, (3) brainstorm its costs, (4) participate in a verbal challenge where they counter the "ideal," and (5) are asked to complete three assignments. In session 2, participants: (1) review homework, (2) engage in role-plays to counter pursuit of the "ideal," (3) discuss ways to challenge "body talk" statements, (4) list ways to resist the pressure to pursue this "ideal" (body activism), (5) discuss barriers to body activism and how to overcome those barriers, and (6) select an exit activity.

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
We will use a media advocacy (MA) intervention as an active, time- and attention-matched control. MA is a 2 session, group-based program with co-leaders (1 peer and 1 clinician). The MA content centers on acknowledging and discussing the role the media has on shaping body image ideals. In session 1, there is a discussion on describing the ideal body in the gay community and how the media impacts this ideal. Following this, participants will watch a video on how the media influences body image among gay men, and the consequences of internalizing these messages. In session 2, participants will watch a second video. Next, the group discusses other forms of media (e.g., pornography, social media) and how it impacts body image.




Primary Outcome Measures :
  1. Eating Disorder Examination, Edition 17.0 (EDE-17) [ Time Frame: Baseline assessment; 1 to 2 week post-intervention assessment; 6 month follow-up assessment; 12 month follow-up assessment; 18 month follow-up assessment; 24 month follow-up assessment ]
    Assess changes in eating disorder symptoms and diagnosis

  2. Eating Pathology Symptoms Inventory [ Time Frame: Baseline assessment; 1 to 2 week post-intervention assessment; 6 month follow-up assessment; 12 month follow-up assessment; 18 month follow-up assessment; 24 month follow-up assessment ]
    Assess changes in pathological eating behaviors


Secondary Outcome Measures :
  1. Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ) [ Time Frame: Baseline assessment; 1 to 2 week post-intervention assessment; 6 month follow-up assessment; 12 month follow-up assessment; 18 month follow-up assessment; 24 month follow-up assessment ]
    Assess internalization of appearance ideal and societal pressure to achieve that ideal

  2. Male Body Attitudes Scale (MBAS-R) [ Time Frame: Baseline assessment; 1 to 2 week post-intervention assessment, 6 month follow-up assessment; 12 month follow-up assessment; 18 month follow-up assessment; 24 month follow-up assessment ]
    Self-report measure assessing muscle, fat, and height dissatisfaction

  3. Depression, Anxiety, Stress Scale (DASS-21) [ Time Frame: Baseline assessment; 1 to 2 week post-intervention assessment; 6 month follow-up assessment; 12 month follow-up assessment; 18 month follow-up assessment; 24 month follow-up assessment ]
    Measures symptoms of depression, anxiety, and stress (non-specific physiological arousal), all contribute to psychological distress (i.e., negative affect)

  4. Drive for Muscularity Scale (DMS) [ Time Frame: Baseline assessment; 1 to 2 week post-intervention assessment; 6 month follow-up assessment; 12 month follow-up assessment; 18 month follow-up assessment; 24 month follow-up assessment ]
    Self-report measure of muscularity-oriented body image and behaviors

  5. Self-Objectification Scale (SOQ) [ Time Frame: Baseline assessment; 1 to 2 week post-intervention assessment; 6 month follow-up assessment; 12 month follow-up assessment; 18 month follow-up assessment; 24 month follow-up assessment ]
    Assess degree to which participant sees their body in an objectified, appearance-based manner v. a non-objectified, competence-based manner

  6. Partner Objectification Scale [ Time Frame: Baseline assessment; 1 to 2 week post-intervention assessment; 6 month follow-up assessment; 12 month follow-up assessment; 18 month follow-up assessment; 24 month follow-up assessment ]
    10 items based on the SOQ which assess degree to which participant sees the bodies of potential partners in an objectified, appearance-based manner v. a non-objectified, competence-based manner

  7. Self-report appearance and performance enhancing drugs [ Time Frame: Baseline assessment; 1 to 2 week post-intervention assessment; 6 month follow-up assessment; 12 month follow-up assessment; 18 month follow-up assessment; 24 month follow-up assessment ]
    Item assess frequency of use of seven drugs that are classified as steroids or are used to change appearance

  8. Sexual Risk Behaviors [ Time Frame: Baseline assessment; 1 to 2 week post-intervention assessment; 6 month follow-up assessment; 12 month follow-up assessment; 18 month follow-up assessment; 24 month follow-up assessment ]
    5 item questionnaire assessing frequency of risky sexual behavior (unprotected sex with partners of unknown HIV status), as well as PrEP use

  9. Dysmorphic Concerns Questionnaire (DCQ) [ Time Frame: Baseline assessment; 1 to 2 week post-intervention assessment; 6 month follow-up assessment; 12 month follow-up assessment; 18 month follow-up assessment; 24 month follow-up assessment ]
    Self-report measure of body dysmorphic disorder symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   In order to be eligible, participants must identify as men.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 to 30
  • Male gender
  • Identifies as gay or bisexual or reports sexual attraction to men
  • Reports body image concerns
  • Able to provide informed consent

Exclusion Criteria:

  • Diagnosis of an eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder)
  • Significant neuropsychiatric illness (e.g., diagnosis of dementia, untreated bipolar disorder, psychosis, or active suicidal ideation)

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): NCT03451513


Contacts
Contact: Aaron J Blashill, Ph.D. 619-594-2245 ablashil@mail.sdsu.edu
Contact: Devon M Kimball, BA 619-594-2037 dmkimball@sdsu.edu

Locations
United States, California
San Diego State University Recruiting
San Diego, California, United States, 92182
Contact: Aaron J Blashill, PhD    619-594-2245    ablashill@mail.sdsu.edu   
Contact: Devon M Kimball, BA    619-594-2037    dmkimball@sdsu.edu   
Sponsors and Collaborators
San Diego State University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Aaron J Blashill, Ph.D. San Diego State University

Publications:

Responsible Party: Aaron Blashill, Assistant Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT03451513     History of Changes
Other Study ID Numbers: HS-2017-0188
1R01MD012698-01 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aaron Blashill, San Diego State University:
Prevention
Sexual minority men
Internalization of the appearance ideal
Body dissatisfaction

Additional relevant MeSH terms:
Feeding and Eating Disorders
Mental Disorders