The Pride Body Project

Study Overview
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Brief Summary
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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.

Detailed Description
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Eating disorders (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder, and eating disorder not otherwise specified) are resistant to treatment and associated with significant morbidity and mortality. Thus, efficacious and efficient eating disorder prevention programs are greatly needed. Extant literature has found that males also experience eating disorders, constituting up to 40% of individuals with diagnostic/sub-threshold eating pathology. Among males, sexual minorities (i.e., gay, bisexual, and non-heterosexual identified individuals) are a salient subgroup that is at substantial risk for developing eating disorders. Indeed, sexual minority males are not only at elevated risk compared to heterosexual males, but are also at elevated risk compared to heterosexual females. The lifetime prevalence for any eating disorder diagnosis among sexual minority males is 8.8%, and subclinical diagnosis is 15.6%. This is in contrast to heterosexual females, in which the prevalence for clinical and subclinical diagnoses are at 4.8% and 8.0%, respectively. These findings indicate that sexual minority males are one of the most vulnerable groups in regard to eating pathology risk. Despite their high vulnerability, there is a paucity of research on eating disorder prevention programs among sexual minority males. The investigators are only aware of one previous prevention program targeting sexual minority males. The PRIDE Body Project, developed and tested by this research team, is a two-session, peer co-led, group, cognitive dissonance-based eating disorder prevention program, based on existing eating disorder prevention programs developed with females (The Body Project). In the preliminary randomized controlled trial (RCT), the researchers found significant and large effects on eating pathology and relevant eating disorder risk factors, compared to a waitlist control condition, at post-treatment and 4-weeks post-treatment. Additionally, preliminary mediation analyses revealed that internalization of the appearance ideal and body dissatisfaction accounted for significant variance in the relationship between treatment condition and eating pathology. These results represent an important first step in demonstrating the acceptability, feasibility, and preliminary efficacy of a brief, peer-led eating disorder prevention program for sexual minority males. Despite these initial findings, future research is needed to further test this promising intervention. Specifically, it is not known if the PRIDE Body Project will exert a clinically and statistically significant effect in comparison to a time and attention-matched control condition. Additionally, it is unknown if the intervention effects will persist beyond 4-weeks post-intervention. To address these gaps, we propose the following aims: Specific Aim 1: Conduct a randomized controlled trial assessing the PRIDE Body Project to a time and attention-matched active control condition. The researchers plan to randomize 348 18 to 35-year-old sexual minority males (in a 1:1 scheme) to either the experimental PRIDE Body Project condition or a media advocacy condition. Participants will be followed for 2 years post-baseline assessment, with major assessment points at: baseline, post-intervention, 6 month, 12 month, 18 month, and 24 month follow-up. Primary outcomes will be eating disorder symptoms and eating disorder onset. The researchers hypothesize that participants randomized to the PRIDE Body Project will yield significantly greater reductions in eating disorder symptoms, and produce lower incidence rates of eating disorders, compared to participants in the media advocacy condition. Specific Aim 2: Conduct longitudinal mediation analyses of the treatment effect. In an effort to more fully understand the mechanisms of change in the PRIDE Body Project, the researchers will assess two theoretically and empirically based mediators of the effect of treatment on eating disorder symptoms. Specifically, the researchers hypothesize that assignment to the PRIDE Body Project condition will lead to significant reductions in body dissatisfaction and internalization of the appearance ideal, which in turn will lead to reductions in eating disorder symptoms/onset. Sexual minority males are one of the most vulnerable groups for developing eating disorders, yet the creation and testing of theoretically and empirically based prevention programs is in its very early stages. The proposed study will provide crucial information on the efficacy of a promising eating disorder prevention program, and has the potential to impact this vulnerable population of young males. Given the brevity of the program, and its emphasis on peer co-leaders, it has high potential for implementation and public health impact. This proposal is also aligned with the purpose and research priorities of PA-15-261 (The Health of Sexual and Gender Minority (SGM) Populations), namely, interventions aimed to ameliorate health disparities in SGM through large-scale design, implementation and evaluation of preventative and/or treatment interventions addressing health issues in SGM populations.

Official Title
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A Brief, Peer Co-led, Group-based Eating Disorder Prevention Program for Sexual Minority Young Adult Men

Conditions
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Body Image, Eating Disorder

Intervention / Treatment
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* Behavioral: Pride Body Project
* Behavioral: Media Advocacy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pride Body Project (PBP)<br>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<br>* 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.<br>|
| Active Comparator: Media Advocacy (MA)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociocultural Attitudes Towards Appearance Questionnaire 3 (SATAQ-3) | Assess internalization of appearance ideal and societal pressure to achieve that ideal | 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) | Assess internalization of appearance ideal and societal pressure to achieve that ideal | 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) | Self-report measure assessing muscle, fat, and height dissatisfaction | 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) | Measures symptoms of depression, anxiety, and stress (non-specific physiological arousal), all contribute to psychological distress (i.e., negative affect) | 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) | Self-report measure of muscularity-oriented body image and 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 | 
| Self-Objectification Scale (SOQ) | Assess degree to which participant sees their body in an objectified, appearance-based manner v. a non-objectified, competence-based manner | 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 | 
| Partner Objectification Scale (POS) | 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 | 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 | 
| Steroid and Appearance Related Drug Items (APEDS) | Item assess frequency of use of seven drugs that are classified as steroids or are used to change appearance | 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 | 
| Sexual Risk Behaviors (SRB) | 5 item questionnaire assessing frequency of risky sexual behavior (unprotected sex with partners of unknown HIV status), as well as PrEP use | 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 | 
| Dysmorphic Concerns Questionnaire (DCQ) | Self-report measure of body dysmorphic disorder symptoms | 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 | 
| Muscle Dysmorphic Disorder Inventory (MDDI) | Self-report measure of body dysmorphic disorder symptoms | 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 | 
| MINI-International Neuropsychiatric Interview MINI | Clinician-based interview for psychiatric disorders | 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 | 
| NIDA-CTN Addictions Severity Index Lite (ASI-Lite) | Clinician-based interview for substance and alcohol use | 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 | 
| BMI Calculations | Measurement of height and weight | 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 | 
| Gender Identity Questionnaire (Gender Identity) | Self-report based measure of gender identity | 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 | 
| The Coronavirus Health Impact Survey (Crisis) V0.2 Adult Self-report Baseline Form | Self-report based measure to assess the effects of COVID-19 on daily functions and mental health | 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 | 
| United States Department of Agriculture (USDA) Food and Nutrition Services US Household Food Security Survey Module | Self-report based measure for food insecurity | 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 | 
| Importance of Gay/Bisexual Community Activities (IBGCA) | Self-report based measure for community involvement | 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 | 
| Structured Clinical Interview for DSM-IV-TR Body Dysmorphic Module (SCID BDD Module) | Clinician-based interview for Body Dysmorphic Disorder | 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 | 
| Social Justice Sexuality Survey (SJSS) | Self-report based measure for community involvement | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body dissatisfaction, Prevention, Sexual minority men, Internalization of the appearance ideal