The Pride Body Project
- Conditions
- Body ImageEating Disorder
- Interventions
- Behavioral: Pride Body ProjectBehavioral: Media Advocacy
- Registration Number
- NCT03451513
- Lead Sponsor
- 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 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."
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 453
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pride Body Project (PBP) Pride Body Project Participants assigned to this condition take part in a two-session intervention based on dissonance theory which encourages them to challenge the body ideal. Media Advocacy (MA) Media Advocacy 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.
- Primary Outcome Measures
Name Time Method Eating Disorder Examination, Edition 17.0 (EDE-17) 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
Eating Pathology Symptoms Inventory 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
Name Time Method Dysmorphic Concerns Questionnaire (DCQ) 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
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 Assess internalization of appearance ideal and societal pressure to achieve that ideal
Gender Identity Questionnaire (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 Self-report based measure of gender identity
NIDA-CTN Addictions Severity Index Lite (ASI-Lite) 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 Clinician-based interview for substance and alcohol use
The Coronavirus Health Impact Survey (Crisis) V0.2 Adult Self-report Baseline Form 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 based measure to assess the effects of COVID-19 on daily functions and mental health
United States Department of Agriculture (USDA) Food and Nutrition Services US Household Food Security Survey Module 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 based measure for food insecurity
Social Justice Sexuality Survey (SJSS) 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 based measure for community involvement
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 Assess internalization of appearance ideal and societal pressure to achieve that ideal
Steroid and Appearance Related Drug Items (APEDS) 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
Sexual Risk Behaviors (SRB) 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
Structured Clinical Interview for DSM-IV-TR Body Dysmorphic Module (SCID BDD Module) 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 Clinician-based interview for Body Dysmorphic Disorder
Self-Objectification Scale (SOQ) 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
Partner Objectification Scale (POS) 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
MINI-International Neuropsychiatric Interview MINI 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 Clinician-based interview for psychiatric disorders
BMI Calculations 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 Measurement of height and weight
Importance of Gay/Bisexual Community Activities (IBGCA) 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 based measure for community involvement
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 Measures symptoms of depression, anxiety, and stress (non-specific physiological arousal), all contribute to psychological distress (i.e., negative affect)
Muscle Dysmorphic Disorder Inventory (MDDI) 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
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 Self-report measure assessing muscle, fat, and height dissatisfaction
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 Self-report measure of muscularity-oriented body image and behaviors
Trial Locations
- Locations (1)
San Diego State University
🇺🇸San Diego, California, United States