Study Summary
This trial will compare the effectiveness of two eating disorder prevention programs, one targeting male-specific risk factors and the other a time and attention matched control.
Eligible Conditions
- Body Dysmorphic Disorder
- Eating Disorders
- Eating Disorder
- Dysmorphic Features
- Exercise Addiction
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 10 Secondary · Reporting Duration: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
Change from baseline to 6-month follow-up related to dimensional changes in Eating Disorder-related psychopathology
Eating Pathology Symptom Inventory-Clinician Rated Version (EPSI-CRV
Immediately post-intervention
Intervention Acceptability
change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
Acceptance and Action Questionnaire 2 (AAQ-II)
Appearance and Performance Enhancing Drug Use (APED; questions were derived from the Adolescents Training and Learning to Avoid Steroids [ATLAS] study)
Depression, Anxiety, Stress Scale (DASS-21)
Difficulties in Emotion Regulation Scale (DERS) short form
Drive for Muscularity Scale (DMS)
Eating Disorder Examination Questionnaire (EDE-Q)
Eating Pathology Symptom Inventory (EPSI)
Male Body Attitudes Scale (MBAS)
Muscle Dysmorphic Disorder Inventory (MDDI)
Muscularity Oriented Eating Test (MOET)
Obligatory Exercise Questionnaire (OEQ)
Self-Objectification Questionnaire (SOQ)
Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Media Advocacy (MA)
1 of 2
Body Project: More than Muscles (MTM)
1 of 2
Active Control
Experimental Treatment
220 Total Participants · 2 Treatment Groups
Primary Treatment: More than Muscles (MTM) · No Placebo Group · N/A
Body Project: More than Muscles (MTM)
Behavioral
Experimental Group · 1 Intervention: More than Muscles (MTM) · Intervention Types: BehavioralMedia Advocacy (MA)
Behavioral
ActiveComparator Group · 1 Intervention: Media Advocacy (MA) · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
More than Muscles (MTM)
2021
N/A
~140
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up
Who is running the clinical trial?
Arlene and Michael Rosen FoundationUNKNOWN
Auburn UniversityLead Sponsor
55 Previous Clinical Trials
13,583 Total Patients Enrolled
Eligibility Criteria
Age 18 - 30 · Male Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You feel uncomfortable or worried about the way your body looks.
References
- Keel, Pamela K., and Tiffany A. Brown. 2010. “Update on Course and Outcome in Eating Disorders”. International Journal of Eating Disorders. Wiley. doi:10.1002/eat.20810.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Leit, Richard A., James J. Gray, and Harrison G. Pope. 2002. “The Media's Representation of the Ideal Male Body: A Cause for Muscle Dysmorphia?”. International Journal of Eating Disorders. Wiley. doi:10.1002/eat.10019.
- CAFRI, G, J THOMPSON, L RICCIARDELLI, M MCCABE, L SMOLAK, and C YESALIS. 2005. “Pursuit of the Muscular Ideal: Physical and Psychological Consequences and Putative Risk Factors”. Clinical Psychology Review. Elsevier BV. doi:10.1016/j.cpr.2004.09.003.
- Tylka, Tracy L.. 2011. “Refinement of the Tripartite Influence Model for Men: Dual Body Image Pathways to Body Change Behaviors”. Body Image. Elsevier BV. doi:10.1016/j.bodyim.2011.04.008.
- Griffiths, Scott, Phillipa Hay, Deborah Mitchison, Jonathan M. Mond, Siân A. McLean, Bryan Rodgers, Robin Massey, and Susan J. Paxton. 2016. “Sex Differences in the Relationships Between Body Dissatisfaction, Quality of Life and Psychological Distress”. Australian and New Zealand Journal of Public Health. Wiley. doi:10.1111/1753-6405.12538.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Pope H, Phillips KA, Olivardia R. The Adonis complex: The secret crisis of male body obsession: Simon and Schuster; 2000.
- Strother, Eric, Raymond Lemberg, Stevie Chariese Stanford, and Dayton Turberville. 2012. “Eating Disorders in Men: Underdiagnosed, Undertreated, and Misunderstood”. Eating Disorders. Informa UK Limited. doi:10.1080/10640266.2012.715512.
- Litt, Dana, and Tonya Dodge. 2008. “A Longitudinal Investigation of the Drive for Muscularity Scale: Predicting Use of Performance Enhancing Substances and Weightlifting Among Males”. Body Image. Elsevier BV. doi:10.1016/j.bodyim.2008.04.002.
- Pope, Harrison G., Jr., Amanda J. Gruber, Precilla Choi, Roberto Olivardia, and Katharine A. Phillips. 1997. “Muscle Dysmorphia: An Underrecognized Form of Body Dysmorphic Disorder”. Psychosomatics. Elsevier BV. doi:10.1016/s0033-3182(97)71400-2.
- Becker CB, Smith LM, Ciao AC. Peer-facilitated eating disorder prevention: A randomized effectiveness trial of cognitive dissonance and media advocacy. Journal of Counseling Psychology. 2006;53(4):550.
- Becker, Carolyn Black, Stephanie Bull, Katherine Schaumberg, Adele Cauble, and Amanda Franco. 2008. “Effectiveness of Peer-led Eating Disorders Prevention: A Replication Trial.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/0022-006x.76.2.347.
- Brown, Tiffany A., and Pamela K. Keel. 2012. “Current and Emerging Directions in the Treatment of Eating Disorders”. Substance Abuse: Research and Treatment. SAGE Publications. doi:10.4137/sart.s7864.
- Harrison K, Cantor J. The relationship between media consumption and eating disorders. Journal of communication. 1997;47(1):40-67
- Hudson, James I., Eva Hiripi, Harrison G. Pope Jr., and Ronald C. Kessler. 2007. “The Prevalence and Correlates of Eating Disorders in the National Comorbidity Survey Replication”. Biological Psychiatry. Elsevier BV. doi:10.1016/j.biopsych.2006.03.040.
- Keel PK. Eating Disorders. Upper Saddle River: Prentice Hall; 2005
- Bramon-Bosch E, Troop NA, Treasure JL. Eating disorders in males: a comparison with female patients. European Eating Disorders Review. 2000;8(4):321-328.
- Griffiths, Scott, Jonathan M. Mond, Zhicheng Li, Sanduni Gunatilake, Stuart B. Murray, Jeanie Sheffield, and Stephen Touyz. 2015. “Self-stigma of Seeking Treatment and Being Male Predict an Increased Likelihood of Having an Undiagnosed Eating Disorder”. International Journal of Eating Disorders. Wiley. doi:10.1002/eat.22413.
- Rodgers, Rachel F., Camille Ganchou, Debra L. Franko, and Henri Chabrol. 2012. “Drive for Muscularity and Disordered Eating Among French Adolescent Boys: A Sociocultural Model”. Body Image. Elsevier BV. doi:10.1016/j.bodyim.2012.03.002.
- Forbush, Kelsie T., Jennifer E. Wildes, Lauren O. Pollack, Danica Dunbar, Jing Luo, Kathryn Patterson, Liana Petruzzi, et al.. 2013. “Development and Validation of the Eating Pathology Symptoms Inventory (EPSI).”. Psychological Assessment. American Psychological Association (APA). doi:10.1037/a0032639.
- Murray, Stuart B., Tiffany A. Brown, Aaron J. Blashill, Emilio J. Compte, Jason M. Lavender, Deborah Mitchison, Jonathan M. Mond, Pamela K. Keel, and Jason M. Nagata. 2019. “The Development and Validation of the Muscularity‐oriented Eating Test: A Novel Measure of Muscularity‐oriented Disordered Eating”. International Journal of Eating Disorders. Wiley. doi:10.1002/eat.23144.
- Brown, Tiffany A., K. Jean Forney, Dennis Pinner, and Pamela K. Keel. 2017. “A Randomized Controlled Trial Ofthe Body Project:more Than Musclesfor Men with Body Dissatisfaction”. International Journal of Eating Disorders. Wiley. doi:10.1002/eat.22724.
- Olivardia, Roberto, Harrison G. Pope Jr., and James I. Hudson. 2000. “Muscle Dysmorphia in Male Weightlifters: A Case-control Study”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/appi.ajp.157.8.1291.
- 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.
- Leit RA, Gray JJ, Pope HG Jr. The media's representation of the ideal male body: a cause for muscle dysmorphia? Int J Eat Disord. 2002 Apr;31(3):334-8. doi: 10.1002/eat.10019.
- Keel PK, Brown TA. Update on course and outcome in eating disorders. Int J Eat Disord. 2010 Apr;43(3):195-204. doi: 10.1002/eat.20810.
- Striegel-Moore RH, Leslie D, Petrill SA, Garvin V, Rosenheck RA. One-year use and cost of inpatient and outpatient services among female and male patients with an eating disorder: evidence from a national database of health insurance claims. Int J Eat Disord. 2000 May;27(4):381-9. doi: 10.1002/(sici)1098-108x(200005)27:43.0.co;2-u.
- Cafri G, Thompson JK, Ricciardelli L, McCabe M, Smolak L, Yesalis C. Pursuit of the muscular ideal: Physical and psychological consequences and putative risk factors. Clin Psychol Rev. 2005 Feb;25(2):215-39. doi: 10.1016/j.cpr.2004.09.003. Epub 2004 Dec 30.
- Olivardia R, Pope HG Jr, Hudson JI. Muscle dysmorphia in male weightlifters: a case-control study. Am J Psychiatry. 2000 Aug;157(8):1291-6. doi: 10.1176/appi.ajp.157.8.1291.
- Leit RA, Pope HG Jr, Gray JJ. Cultural expectations of muscularity in men: the evolution of playgirl centerfolds. Int J Eat Disord. 2001 Jan;29(1):90-3. doi: 10.1002/1098-108x(200101)29:13.0.co;2-f.
- Pope HG Jr, Olivardia R, Gruber A, Borowiecki J. Evolving ideals of male body image as seen through action toys. Int J Eat Disord. 1999 Jul;26(1):65-72. doi: 10.1002/(sici)1098-108x(199907)26:13.0.co;2-d.
- Pope HG Jr, Gruber AJ, Choi P, Olivardia R, Phillips KA. Muscle dysmorphia. An underrecognized form of body dysmorphic disorder. Psychosomatics. 1997 Nov-Dec;38(6):548-57. doi: 10.1016/S0033-3182(97)71400-2.
- Tiffany Brown 2022. "Evaluating Body Acceptance Programs for Young Men". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05258409.
Frequently Asked Questions
What are the primary objectives of this clinical experiment?
"The primary purpose of this clinical trial is to determine the impact of treatment on Eating Disorder-related psychopathology through evaluation with Muscularity Oriented Eating Test (MOET). Secondary endpoints for assessment include Male Body Attitudes Scale (MBAS), Obligatory Exercise Questionnaire (OEQ) and Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ). The MOET, MBAS, OEQ and SATAQ are all scored over a range from 1 to 6, 4 or 5 depending upon the metric." - Anonymous Online Contributor
Unverified Answer
Does this research endeavor seek to include elderly participants?
"Participants aged between 18 and 30 are the target demographic for this trial - there are 279 studies focusing on younger patients, while 661 examine those over 65." - Anonymous Online Contributor
Unverified Answer
Are there currently any enrollment options available for this trial?
"Affirmative, the clinicaltrial.gov website indicates this research is presently accepting enrollees. This trial was unveiled on August 16th 2022 and most recently revised on September 19th of the same year. 220 volunteers are required to participate in this study at 1 medical centre." - Anonymous Online Contributor
Unverified Answer
Is my profile suitable for enrolment in this research experiment?
"This medical study is accepting 220 participants between the ages of 18 and 30 with certain dietary habits. To be eligible for this clinical trial, applicants must meet these criteria." - Anonymous Online Contributor
Unverified Answer
What is the current scale of enrollment for this medical experiment?
"Affirmative. According to the information stored on clinicaltrials.gov, this trial is currently recruiting participants with a start date of August 16th 2022 and updated on September 19th 2022. A total of 220 volunteers are needed from 1 site." - Anonymous Online Contributor
Unverified Answer