The Pride Body Project
Condition: Eating Disorder; Body Image
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

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.
    

Detailed description: 
      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."
    

Intervention name(s): Pride Body Project; Media Advocacy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
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)
Primary purpose: Prevention
Keywords: Prevention; Sexual minority men; Internalization of the appearance ideal; Body dissatisfaction