NCT04687228

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

1.5 years

First QC Date

December 15, 2020

Last Update Submit

October 31, 2022

Conditions

Keywords

MaleMuscularity Oriented EatingExerciseEating DisorderBody Image

Outcome Measures

Primary Outcomes (3)

  • Eating Disorder Examination Questionnaire (EDE-Q)

    The EDE-Q is a 28-item measure scored on a 7-point rating scale with scores ranging from 0 to 168 (scores higher than 4 on individual questions are indicative of clinical levels). The EDE-Q is a transdiagnostic measure of Eating Disorder symptoms with high scores indicating elevated eating pathology.

    change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up

  • Muscle Dysmorphic Disorder Inventory (MDDI)

    The MDDI is a 13-item measure for muscle dysmorphia symptoms, which is a common feature of Eating Disorders in men. Items are scored 0 (never) to 4 (always) with higher scores indicating greater muscle dysmorphic symptoms. Scores on this measure range 0 to 52.

    change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up

  • Eating Pathology Symptom Inventory-Clinician Rated Version (EPSI-CRV)

    The EPSI-CRV is a semi-structured interview that assesses dimensional constructs of psychopathology associated with Diagnostic and Statistical Manual-5 Eating Disorders. The interview will take approximately 40 minutes to complete.

    Change from baseline to 6-month follow-up related to dimensional changes in Eating Disorder-related psychopathology.

Secondary Outcomes (10)

  • Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ)

    change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up

  • Drive for Muscularity Scale (DMS)

    change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up

  • Male Body Attitudes Scale (MBAS)

    change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up

  • Self-Objectification Questionnaire (SOQ)

    change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up

  • Obligatory Exercise Questionnaire (OEQ)

    change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up

  • +5 more secondary outcomes

Study Arms (2)

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.

Behavioral: Media Advocacy (MA)

Body Project: More than Muscles (MTM)

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.

Behavioral: More than Muscles (MTM)

Interventions

In session 1, the primary activities are: 1) define the "ideal" body type for men in our culture, 2) discuss the origin and perpetration of the "ideal," 3) brainstorm the costs of pursuing the "ideal," 4) participate in a verbal challenge during which participants counter the "ideal" message, and (5) are asked to complete three "homework" assignments (i.e., a letter to an adolescent boy, a behavioral challenge, and a mirror exposure assignment). In session 2, the primary activities are: 1) reviewing homework, 2) engage in role-plays to counter/discourage pursuit of the "ideal," 3) discuss ways to challenge and avoid "negative body talk" statements, 4) list ways to resist the pressure to pursue this "ideal" both individually and as a group within the larger community (i.e., body activism), 5) discuss barriers to body activism and strategies to overcome those barriers, and 6) individually select an exit exercise to continue to actively challenge the appearance ideal.

Also known as: Body Project
Body Project: More than Muscles (MTM)

MA content generally centers on acknowledging and discussing the role the media has on shaping body image ideals. Session 1: In session 1, similar to MTM, the primary activities will include: (1) describing the ideal body for men in our culture, (2) discussing how the media impacts this ideal, with a particular focus on advertising. Following this, participants will (3) watch a video on how the media influences body image among men, and the consequences of internalizing these messages. Session 2: In session 2, content will continue by further discussion of the video showed in session 1, with participants sharing their reactions. Next, the group discusses the attainability of the ideal as well as discusses other forms of media (e.g., social media) and how it impacts body image.

Media Advocacy (MA)

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPerson who self-identify as male.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego, Eating Disorder Center for Treatment and Research

San Diego, California, 92093, United States

Location

Related Publications (24)

  • Strother E, Lemberg R, Stanford SC, Turberville D. Eating disorders in men: underdiagnosed, undertreated, and misunderstood. Eat Disord. 2012;20(5):346-55. doi: 10.1080/10640266.2012.715512.

    PMID: 22985232BACKGROUND
  • 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.

    PMID: 16815322BACKGROUND
  • Keel PK. Eating Disorders. Upper Saddle River: Prentice Hall; 2005

    BACKGROUND
  • Kirkbride J, Coid JW, Morgan C, Fearon P, Dazzan P, Yang M, Lloyd T, Harrison GL, Murray RM, Jones PB. Translating the epidemiology of psychosis into public mental health: evidence, challenges and future prospects. J Public Ment Health. 2010 Jun;9(2):4-14. doi: 10.5042/jpmh.2010.0324.

    PMID: 21160544BACKGROUND
  • Rodgers RF, Ganchou C, Franko DL, Chabrol H. Drive for muscularity and disordered eating among French adolescent boys: a sociocultural model. Body Image. 2012 Jun;9(3):318-23. doi: 10.1016/j.bodyim.2012.03.002. Epub 2012 Apr 10.

    PMID: 22494958BACKGROUND
  • Tylka TL. Refinement of the tripartite influence model for men: dual body image pathways to body change behaviors. Body Image. 2011 Jun;8(3):199-207. doi: 10.1016/j.bodyim.2011.04.008. Epub 2011 Jun 12.

    PMID: 21664886BACKGROUND
  • Litt D, Dodge T. A longitudinal investigation of the Drive for Muscularity Scale: predicting use of performance enhancing substances and weightlifting among males. Body Image. 2008 Dec;5(4):346-51. doi: 10.1016/j.bodyim.2008.04.002. Epub 2008 Jul 21.

    PMID: 18644753BACKGROUND
  • 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.

    PMID: 11920996BACKGROUND
  • 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.

    PMID: 15642647BACKGROUND
  • 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.

    PMID: 9427852BACKGROUND
  • 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.

    PMID: 10910793BACKGROUND
  • 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.

    BACKGROUND
  • Griffiths S, Hay P, Mitchison D, Mond JM, McLean SA, Rodgers B, Massey R, Paxton SJ. Sex differences in the relationships between body dissatisfaction, quality of life and psychological distress. Aust N Z J Public Health. 2016 Dec;40(6):518-522. doi: 10.1111/1753-6405.12538. Epub 2016 Jul 3.

    PMID: 27372301BACKGROUND
  • Griffiths S, Mond JM, Li Z, Gunatilake S, Murray SB, Sheffield J, Touyz S. Self-stigma of seeking treatment and being male predict an increased likelihood of having an undiagnosed eating disorder. Int J Eat Disord. 2015 Sep;48(6):775-8. doi: 10.1002/eat.22413. Epub 2015 Jun 6.

    PMID: 26052695BACKGROUND
  • 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.

    PMID: 10744844BACKGROUND
  • Brown TA, Keel PK. Current and emerging directions in the treatment of eating disorders. Subst Abuse. 2012;6:33-61. doi: 10.4137/SART.S7864. Epub 2012 Mar 29.

    PMID: 22879753BACKGROUND
  • 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.

    PMID: 20186717BACKGROUND
  • 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.

    PMID: 10349585BACKGROUND
  • 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.

    PMID: 11135340BACKGROUND
  • Pope H, Phillips KA, Olivardia R. The Adonis complex: The secret crisis of male body obsession: Simon and Schuster; 2000.

    BACKGROUND
  • Harrison K, Cantor J. The relationship between media consumption and eating disorders. Journal of communication. 1997;47(1):40-67.

    BACKGROUND
  • Brown TA, Forney KJ, Pinner D, Keel PK. A randomized controlled trial of The Body Project: More Than Muscles for men with body dissatisfaction. Int J Eat Disord. 2017 Aug;50(8):873-883. doi: 10.1002/eat.22724. Epub 2017 May 8.

    PMID: 28481431BACKGROUND
  • 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.

    BACKGROUND
  • Becker CB, Bull S, Schaumberg K, Cauble A, Franco A. Effectiveness of peer-led eating disorders prevention: a replication trial. J Consult Clin Psychol. 2008 Apr;76(2):347-54. doi: 10.1037/0022-006X.76.2.347.

    PMID: 18377130BACKGROUND

Related Links

MeSH Terms

Conditions

Congenital AbnormalitiesFeeding and Eating DisordersMotor Activity

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will remain unaware of what group they have been randomized to as both groups will be actively be participating in groups focused on male body image.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator & Assistant Professor

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 29, 2020

Study Start

February 15, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

November 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Principal Investigator will comply with data storage and sharing guidelines associated with her institutions best practices. Participant information will be de-identified in cases of sharing to maintain anonymity.

Locations