Evaluating Body Acceptance Programs for Young Men

NCT ID: NCT04687228

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Body Image Disturbance Eating Disorder Symptom Dysmorphia Eating Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Media Advocacy (MA)

Intervention Type BEHAVIORAL

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.

Body Project: More than Muscles (MTM)

Participants assigned to this condition take part in a two-session intervention based on dissonance theory which encourages them to challenge the body ideal.

Group Type EXPERIMENTAL

More than Muscles (MTM)

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

More than Muscles (MTM)

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.

Intervention Type BEHAVIORAL

Media Advocacy (MA)

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Body Project

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Michael and Arlene Rosen Foundation

UNKNOWN

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tiffany Brown

Principal Investigator & Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

San Diego, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22985232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16815322 (View on PubMed)

Keel PK. Eating Disorders. Upper Saddle River: Prentice Hall; 2005

Reference Type 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.

Reference Type BACKGROUND
PMID: 21160544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22494958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21664886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18644753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11920996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15642647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9427852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10910793 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 27372301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26052695 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10744844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22879753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20186717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10349585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11135340 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 28481431 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 18377130 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201229S

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

My Life and My Experiences Project
NCT06821178 RECRUITING NA