The Pride Body Project

NCT03451513 | Completed DMC

• 2 other identifiers: HS-2017-01881R01MD012698-01
• Study Type: interventional
• Target: 453
• Locations: 1 country
• Sites: 1

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 35, identify as men, are gay, bisexual, or experience sexual attraction to men, and who express body image concerns for the San Diego area.

Conditions

Eating Disorder; Body Image

Keywords

Prevention; Sexual minority men; Internalization of the appearance ideal; Body dissatisfaction

Outcome Measures

Primary Outcomes (2)

• Eating Disorder Examination, Edition 17.0 (EDE-17)

  Assess changes in eating disorder symptoms and diagnosis

  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

• Eating Pathology Symptoms Inventory

  Assess changes in pathological eating behaviors

  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

Secondary Outcomes (20)

• Sociocultural Attitudes Towards Appearance Questionnaire 3 (SATAQ-3)

  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

• Sociocultural Attitudes Towards Appearance Questionnaire Revised (SATAQ-4R)

  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

• Male Body Attitudes Scale/Revised (MBAS-R)

  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

• Depression, Anxiety, Stress Scale (DASS)

  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

• Drive for Muscularity Scale (DMS)

  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

Study Arms (2)

Pride Body Project (PBP)

EXPERIMENTAL

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

Media Advocacy (MA)

ACTIVE COMPARATOR

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

Interventions

Pride Body Project BEHAVIORAL

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.

Pride Body Project (PBP)

Media Advocacy BEHAVIORAL

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.

Media Advocacy (MA)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: In order to be eligible, participants must identify as men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 35
• Male gender
• Identifies as gay or bisexual or reports sexual attraction to men
• Reports body image concerns
• Able to provide informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• San Diego State University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Related Publications (12)

• Klump KL, Bulik CM, Kaye WH, Treasure J, Tyson E. Academy for eating disorders position paper: eating disorders are serious mental illnesses. Int J Eat Disord. 2009 Mar;42(2):97-103. doi: 10.1002/eat.20589. No abstract available.

  PMID: 18951455 BACKGROUND

• Mitchell JE, Crow S. Medical complications of anorexia nervosa and bulimia nervosa. Curr Opin Psychiatry. 2006 Jul;19(4):438-43. doi: 10.1097/01.yco.0000228768.79097.3e.

  PMID: 16721178 BACKGROUND

• Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74.

  PMID: 21727255 BACKGROUND

• Brownley KA, Berkman ND, Sedway JA, Lohr KN, Bulik CM. Binge eating disorder treatment: a systematic review of randomized controlled trials. Int J Eat Disord. 2007 May;40(4):337-48. doi: 10.1002/eat.20370.

  PMID: 17370289 BACKGROUND

• Hudson JI, Hiripi E, Pope HG Jr, Kessler RC. The prevalence and correlates of eating disorders in the National Comorbidity Survey Replication. Biol Psychiatry. 2007 Feb 1;61(3):348-58. doi: 10.1016/j.biopsych.2006.03.040. Epub 2006 Jul 3.

  PMID: 16815322 BACKGROUND

• Russell CJ, Keel PK. Homosexuality as a specific risk factor for eating disorders in men. Int J Eat Disord. 2002 Apr;31(3):300-6. doi: 10.1002/eat.10036.

  PMID: 11920991 BACKGROUND

• Brown TA, Keel PK. The impact of relationships, friendships, and work on the association between sexual orientation and disordered eating in men. Eat Disord. 2013;21(4):342-59. doi: 10.1080/10640266.2013.797825.

  PMID: 23767674 BACKGROUND

• Feldman MB, Meyer IH. Eating disorders in diverse lesbian, gay, and bisexual populations. Int J Eat Disord. 2007 Apr;40(3):218-26. doi: 10.1002/eat.20360.

  PMID: 17262818 BACKGROUND

• Brown TA, Keel PK. A randomized controlled trial of a peer co-led dissonance-based eating disorder prevention program for gay men. Behav Res Ther. 2015 Nov;74:1-10. doi: 10.1016/j.brat.2015.08.008. Epub 2015 Sep 3.

  PMID: 26342904 BACKGROUND

• Stice E, Marti CN, Spoor S, Presnell K, Shaw H. Dissonance and healthy weight eating disorder prevention programs: long-term effects from a randomized efficacy trial. J Consult Clin Psychol. 2008 Apr;76(2):329-40. doi: 10.1037/0022-006X.76.2.329.

  PMID: 18377128 BACKGROUND

• Stice E, Rohde P, Gau J, Shaw H. An effectiveness trial of a dissonance-based eating disorder prevention program for high-risk adolescent girls. J Consult Clin Psychol. 2009 Oct;77(5):825-34. doi: 10.1037/a0016132.

  PMID: 19803563 BACKGROUND

• Stice E, Shaw H, Burton E, Wade E. Dissonance and healthy weight eating disorder prevention programs: a randomized efficacy trial. J Consult Clin Psychol. 2006 Apr;74(2):263-75. doi: 10.1037/0022-006X.74.2.263.

  PMID: 16649871 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Aaron J Blashill, Ph.D.

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 1, 2018
• Study Start: January 24, 2018
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)