- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03451513
The Pride Body Project (PBP)
A Brief, Peer Co-led, Group-based Eating Disorder Prevention Program for Sexual Minority Young Adult Men
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92182
- San Diego State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Media Advocacy (MA)
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.
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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.
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Experimental: Pride Body Project (PBP)
Participants assigned to this condition take part in a two-session intervention based on dissonance theory which encourages them to challenge the body ideal.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Assess changes in eating disorder symptoms and diagnosis
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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
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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
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Assess changes in pathological eating behaviors
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Assess internalization of appearance ideal and societal pressure to achieve that ideal
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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
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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
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Assess internalization of appearance ideal and societal pressure to achieve that ideal
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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
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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
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Self-report measure assessing muscle, fat, and height dissatisfaction
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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
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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
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Measures symptoms of depression, anxiety, and stress (non-specific physiological arousal), all contribute to psychological distress (i.e., negative affect)
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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
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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
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Self-report measure of muscularity-oriented body image and behaviors
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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
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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
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Assess degree to which participant sees their body in an objectified, appearance-based manner v. a non-objectified, competence-based manner
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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
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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
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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
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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
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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
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Item assess frequency of use of seven drugs that are classified as steroids or are used to change appearance
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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
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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
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5 item questionnaire assessing frequency of risky sexual behavior (unprotected sex with partners of unknown HIV status), as well as PrEP use
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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
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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
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Self-report measure of body dysmorphic disorder symptoms
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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
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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
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Self-report measure of body dysmorphic disorder symptoms
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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
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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
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Clinician-based interview for psychiatric disorders
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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
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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
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Clinician-based interview for substance and alcohol use
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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
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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
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Measurement of height and weight
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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
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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
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Self-report based measure of gender identity
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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
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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
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Self-report based measure to assess the effects of COVID-19 on daily functions and mental health
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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
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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
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Self-report based measure for food insecurity
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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
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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
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Self-report based measure for community involvement
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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
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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
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Clinician-based interview for Body Dysmorphic Disorder
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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
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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
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Self-report based measure for community involvement
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aaron J Blashill, Ph.D., San Diego State University
Publications and helpful links
General Publications
- 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. Erratum In: Biol Psychiatry. 2012 Jul 15;72(2):164.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-2017-0188
- 1R01MD012698-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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