Eating DisorderPBPNCT03451513
The Pride Body Project
A study testing Pride Body Project and Media Advocacy in people with Eating Disorder and Body Image, run by San Diego State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder, Body Image
- What is being tested?
- Pride Body Project and Media Advocacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2018to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92182
About this study
Official title: A Brief, Peer Co-led, Group-based Eating Disorder Prevention Program for Sexual Minority Young Adult Men
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.
Read the 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."
- Conditions
- Eating Disorder, Body Image
- Being tested
- Pride Body Project, Media Advocacy
- Keywords
- Prevention, Sexual minority men, Internalization of the appearance ideal, Body dissatisfaction
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pride Body ProjectBehavioural
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.
Media AdvocacyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Media Advocacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination, Edition 17.0 (EDE-17)
Assess changes in eating disorder symptoms and diagnosis
Measured: 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
Measured: 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)
Assess internalization of appearance ideal and societal pressure to achieve that ideal
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start24 Jan 2018
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Aaron Blashill, San Diego State University
- Investigators
- Aaron J Blashill, Ph.D., Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451513
- Sponsor's protocol ID
- HS-2017-0188
- Other IDs
- 1R01MD012698-01
- Acronym
- PBP
- Status last verified
- Nov 2023
- First submitted
- 20 Feb 2018
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18951455Mitchell 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.
PubMed 16721178Arcelus 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.
PubMed 21727255Brownley 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.
PubMed 17370289Hudson 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.
PubMed 16815322Russell 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.
PubMed 11920991Brown 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.
PubMed 23767674Feldman 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.
PubMed 17262818Brown 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.
PubMed 26342904Stice 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.
PubMed 18377128Stice 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.
PubMed 19803563Stice 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.
PubMed 16649871
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief, Peer Co-led, Group-based Eating Disorder Prevention Program for Sexual Minority Young Adult Men
- ClinicalTrials.gov ID
- NCT03451513
- Acronym / sponsor ID
- PBP / HS-2017-0188
- Conditions
- Eating Disorder, Body Image
- Keywords
- Prevention, Sexual minority men, Internalization of the appearance ideal, Body dissatisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pride Body Project (PBP) | Experimental | Behavioral: Pride Body ProjectParticipants 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) | Active comparator | Behavioral: Media AdvocacyParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pride Body ProjectPBP 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. | Behavioural | Pride Body Project (PBP) |
| Media AdvocacyWe 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. | Behavioural | Media Advocacy (MA) |
Primary outcome
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
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
20 secondary outcomes
Sociocultural Attitudes Towards Appearance Questionnaire 3 (SATAQ-3)
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
Sociocultural Attitudes Towards Appearance Questionnaire Revised (SATAQ-4R)
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
Male Body Attitudes Scale/Revised (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
Depression, Anxiety, Stress Scale (DASS)
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
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-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
Partner Objectification Scale (POS)
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
Steroid and Appearance Related Drug Items (APEDS)
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
Sexual Risk Behaviors (SRB)
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
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
Muscle Dysmorphic Disorder Inventory (MDDI)
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
MINI-International Neuropsychiatric Interview MINI
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
NIDA-CTN Addictions Severity Index Lite (ASI-Lite)
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
BMI Calculations
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
Gender Identity Questionnaire (Gender Identity)
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
The Coronavirus Health Impact Survey (Crisis) V0.2 Adult Self-report Baseline Form
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
United States Department of Agriculture (USDA) Food and Nutrition Services US Household Food Security Survey Module
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
Importance of Gay/Bisexual Community Activities (IBGCA)
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
Structured Clinical Interview for DSM-IV-TR Body Dysmorphic Module (SCID BDD Module)
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
Social Justice Sexuality Survey (SJSS)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 18951455Klump 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.
- Background: PubMed 16721178Mitchell 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.
- Background: PubMed 21727255Arcelus 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.
- Background: PubMed 17370289Brownley 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.
- Background: PubMed 16815322Hudson 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.
- Background: PubMed 11920991Russell 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.
- Background: PubMed 23767674Brown 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.
- Background: PubMed 17262818Feldman 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.
- Background: PubMed 26342904Brown 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.
- Background: PubMed 18377128Stice 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.
- Background: PubMed 19803563Stice 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.
- Background: PubMed 16649871Stice 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron J Blashill, Ph.D. principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pride Body Project and Media Advocacy in people with Eating Disorder and Body Image, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03451513, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.