Clinical trial NCT04687228: Evaluating Body Acceptance Programs for Young Men
Official title: Evaluating Body Acceptance Programs for Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Image Disturbance
Eating Disorder Symptom
Dysmorphia
Eating Disorders
Keywords: Male
Muscularity Oriented Eating
Exercise
Eating Disorder
Body Image
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Michael and Arlene Rosen Foundation
First posted: 2020-12-29
Enrollment: 137
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will briefly be screened for eligibility criteria by phone. Eligible participants will be assessed using two structured clinical interviews (SCID-5 \& EPSI-CRV) and complete a set of self-report measures at baseline. Following assessment participants will be randomized into one of two groups. One group will receive a dissonance-based intervention known as the More than Muscles (MTM), while other participants will engage in a Media Advocacy (MA) active control. Participants will complete the same set of self-report measures from baseline, after their final group, at 1-month follow-up and at 6-month follow-up. During the 6-month follow-up participants will also be reassessed using the same structured clinical interviews at baseline.
Primary purpose: PREVENTION

Brief summary: While eating disorders in males are often overlooked, up to 7 million men in the United States will experience an Eating Disorder in their lifetime. Critically, men are less likely to seek treatment for an Eating Disorder compared to females. Therefore, prevention programs that target male-specific Eating Disorder risk factors prior to the development of an eating or appearance-related disorder are crucial in reducing eating disorders in this population. Preliminary work by our group established the initial efficacy of a novel program, the Body Project: More than Muscles (MTM) compared to assessment-only control. This study will replicate and extend this research by comparing MTM to a time and attention-matched control used in previous eating disorder prevention work, media advocacy (MA).

Detailed description: Although often overlooked, Eating Disorders in men are a serious and deadly public health problem, affecting up to 7 million men in the United States. Efficacious, promulgated Eating Disorder treatments largely remain unknown, particularly for males. Over recent decades, men have faced increasing social pressures to obtain an unrealistically lean and muscular physique, which have contributed to body dissatisfaction and unhealthy eating and weight control behaviors among men, including symptoms of both Eating Disorders and muscle dysmorphia (body image disturbance characterized by the unhealthy pursuit of muscularity. Despite the impairment and distress associated with these conditions, males are less likely to seek treatment than females, in part due to stigma. Importantly, for those men who do seek help, existing treatments are targeted mostly towards females, rarely address male-specific risk factors, and are ineffective for over 50% of patients. Thus, well-accepted, easily replicable preventative programs that target male-specific Eating Disorder risk factors prior to disorder onset are critical to reduce the public health burden and disparities associated with eating disorders in men.

Research supports that for men, pressures from media, friends, partners, and family to pursue a lean, muscular body can lead to body-ideal internalization -- the belief that one's self-worth and value are defined by physical appearance. This can lead to dissatisfaction with muscularity and body fat, which in turn, contributes to eating disorder and muscle dysmorphia-related attitudes and behaviors. Thus, targeting internalization of the lean, muscular ideal portrayed in media culture would be important for reducing both Eating Disorder and muscle dysmorphia symptoms for men.

While studies have targeted body-ideal internalization in groups of women using dissonance-based interventions, until recently, no programs had been developed to address internalization of the lean, muscular body ideal for men. Our group recently developed and evaluated the Body Project: More than Muscles (MTM) in a randomized controlled trial (RCT) to target eating disorder and muscle dysmorphia risk factors in body-dissatisfied men. Results demonstrated significantly greater decreases in body-ideal internalization, dietary restraint, drive for muscularity, bulimic symptoms (e.g., binge eating, self-induced vomiting, laxatives, fasting, and/or excessive exercise), and muscle dysmorphia symptoms for men in the MTM intervention compared to assessment-only controls, both pre- to post-intervention and at 1-month follow-up. Further, body-ideal internalization mediated intervention outcomes for bulimic and muscle dysmorphia symptoms, supporting that the intervention's effects were exerted through reducing internalization of lean, muscular ideal images portrayed in media.

While initial results for MTM are promising, prior to disseminating this program to a wider audience, the present study will replicate and extend effects observed in the previous trial by comparing the intervention to a time- and attention-matched media advocacy (MA) active control condition used in previous Eating Disorder prevention programs. The present study will also explore the impact of MTM on additional risk factors for Eating Disorders and muscle dysmorphia in men not explicitly included in the previous RCT including unhealthy exercise, self- and other-objectification, appearance- and performance-enhancing drug (APED) use, and overall levels of depression, stress, and anxiety.

Results from the present study will provide critical support to help translate research on Eating Disorders and muscle dysmorphia in men into evidence-based prevention of these problems. MTM represents a novel approach to eating disorder prevention in this underserved population. This intervention has potential for wide dissemination, as peer-led interventions in women have demonstrated comparable impact to professional-led interventions. Further, if effects for MTM replicate, future research could adapt online or web-based versions of the program to help disseminate this program to a wider audience of men across the country. Thus, if results support the intervention's efficacy, this could lead to the expanded delivery of the intervention into university-based or online effectiveness trials to help prevent Eating Disorders and reduce body dissatisfaction for men at a national level.

Eligibility criteria: Inclusion Criteria:

* 18 to 30 years old
* Identify as male
* Endorse body image concerns
* Speak English and able to provide informed consent

Exclusion Criteria:

* Diagnosis of a DSM-5 eating disorder determined by SCID-5
* Significant neuropsychiatric illness (e.g., dementia, untreated severe psychiatric illness determined by SCID-unmedicated bipolar disorder, psychosis, or active suicidal ideation)
* Older than 30 years old
* Younger than 18 years old

Primary outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
measure: Muscle Dysmorphic Disorder Inventory (MDDI)
timeFrame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
measure: Eating Pathology Symptom Inventory-Clinician Rated Version (EPSI-CRV)
timeFrame: Change from baseline to 6-month follow-up related to dimensional changes in Eating Disorder-related psychopathology.
Secondary outcomes:
measure: Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ)
timeFrame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
measure: Drive for Muscularity Scale (DMS)
timeFrame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
measure: Male Body Attitudes Scale (MBAS)
timeFrame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
measure: Self-Objectification Questionnaire (SOQ)
timeFrame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
measure: Obligatory Exercise Questionnaire (OEQ)
timeFrame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
measure: Appearance and Performance Enhancing Drug Use (APED; questions were derived from the Adolescents Training and Learning to Avoid Steroids [ATLAS] study)
timeFrame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
measure: Depression, Anxiety, Stress Scale (DASS-21)
timeFrame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
measure: Difficulties in Emotion Regulation Scale (DERS) short form
timeFrame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
measure: Acceptance and Action Questionnaire 2 (AAQ-II)
timeFrame: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
measure: Intervention Acceptability
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego, Eating Disorder Center for Treatment and Research
state: California
Study officials:
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