Eating Disorders Clinical Trial
Official title:
Evaluating Body Acceptance Programs for Young Men
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).
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05656859 -
Prevalence of Eating Disorders Among Patients in the Department of Health Promotion
|
||
Completed |
NCT04085861 -
Mental Health in Dancers; an Intervention Study
|
N/A | |
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Enrolling by invitation |
NCT04174703 -
Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
|
N/A | |
Terminated |
NCT04278755 -
Binge Eating & Birth Control
|
Phase 2 | |
Withdrawn |
NCT03050632 -
Effects of Cognitive and Emotional Functioning on Treatment Outcomes
|
N/A | |
Completed |
NCT02567890 -
Swedish Body Project for Prevention of Eating Disorders
|
N/A | |
Completed |
NCT02484794 -
Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application
|
N/A | |
Completed |
NCT02252822 -
Improving Treatment Engagement for Adolescents With Bulimia Nervosa
|
N/A | |
Completed |
NCT02021344 -
Mental Health First Aid for College Students
|
N/A | |
Completed |
NCT00601354 -
Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder
|
N/A | |
Completed |
NCT00418977 -
Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents
|
N/A | |
Completed |
NCT00304187 -
Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
|
Phase 2 | |
Completed |
NCT00733525 -
Effectiveness of Stepped Care Versus Best Available Care for Bulimia Nervosa
|
N/A | |
Active, not recruiting |
NCT04779216 -
Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa
|
Phase 3 | |
Completed |
NCT04433663 -
Eating Disorders, Self Regulation and Mentalization
|
N/A | |
Recruiting |
NCT05509257 -
Naltrexone Neuroimaging in Teens With Eating Disorders
|
Early Phase 1 | |
Completed |
NCT04509531 -
Building Resilience in Cyberbullying Victims
|
N/A | |
Recruiting |
NCT05730348 -
Mealtime Anxiety in Eating Disorders
|
||
Enrolling by invitation |
NCT05814653 -
A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders
|
N/A |