Eating DisorderNCT03013244
Reducing Eating Disorder Risk Factors Among College-Aged Males
A study testing The Body Project: More Than Muscles in people with Eating Disorder, run by Florida State University at 1 site in United States.
Trial summary
The purpose of the present study was to investigate the acceptability and efficacy of a cognitive dissonance-based (DB) intervention in reducing eating disorder and muscle dysmorphia risk factors in men with body dissatisfaction. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Eating Disorder
- What is being tested?
- The Body Project: More Than Muscles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male
- do not meet criteria for an eating disorder (based on phone screen interview)
- endorse body image concerns
- 18 years -30 years
- agree to participate in a positive body image program.
Who cannot join
- Individuals under 18 years of age
- Individuals who do not meet criterion a, b, c, or d (as outlined in the inclusion criteria)
- Individuals who meet full criteria for an eating disorder based on responses on the phone screen
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: A Randomized Controlled Trial of The Body Project: More Than Muscles for Males With Body Dissatisfaction
The purpose of the present study was to investigate the acceptability and efficacy of a cognitive dissonance-based (DB) intervention in reducing eating disorder and muscle dysmorphia risk factors in men with body dissatisfaction. The investigators hypothesized that the program would reduce eating disorder risk factors to a greater degree compared to wait list control and that these effects would be maintained at 1 month follow-up.
Read the detailed description
BACKGROUND \& PURPOSE The current project sought to examine the acceptability and efficacy of a cognitive dissonance-based (DB) eating disorder prevention program for college-aged men with body image concerns. Eating disorders represent a public health problem for which efficacious, disseminable treatments largely remain unknown, particularly for males. Epidemiological data support the increasing prevalence of eating disorders and body image concerns among men; however, few programs have been developed to address concerns relevant to men, and many men feel uncomfortable in programs that identify eating disorders as a "female" problem. Given that eating disorders are particularly difficult to treat, disseminable interventions that can target high-risk groups prior to eating disorder onset may be the best way to reduce the public health burden associated with eating disorders. As body image concerns represent the most potent and consistent risk factor for developing eating disorders in males and females, men with body image concerns represent one such high-risk, but underserved, group.
Recent prevention research has used DB principles to challenge thin-ideal internalization to decrease the likelihood of developing an eating disorder in female youth. Additionally, the investigators recently adapted and evaluated a DB program for gay males (The PRIDE Body Project), who represent another high-risk group among men. Dissonance theory states that when individuals engage in counter-attitudinal behavior they experience psychological discomfort, leading them to alter their attitudes to be congruent with their behavior. Several studies have supported the efficacy of DB programs in reducing eating disorder risk among females and results from The PRIDE Body Project extends the efficacy of these programs to gay males. These DB interventions have utilized peer co-leaders, capitalizing on the importance of peer influences on eating behaviors among college-aged females and males.
To date, other than The PRIDE Body Project, no studies have examined eating disorder prevention interventions for high-risk groups of males. Notably, the success of The PRIDE Body Project and several lines of research support that adapting a DB program may also be helpful in reducing eating disorder risk among young men with body image concerns. First, internalization of the mesomorphic ideal plays a central role in risk for developing eating pathology in males. Thus, an intervention targeting internalization of this body ideal may be particularly helpful for males. Second, studies support that peers influence body dissatisfaction and disordered eating in males concurrently and prospectively through socialization. This suggests that men, regardless of sexual orientation, may benefit from a peer-led DB program to address body image concerns. This work could fill a critical gap in the care provided to a growing demographic among those who suffer from eating disorders.
Thus, the aim of the present study was to determine the acceptability and efficacy of adapting a cognitive DB intervention for use in college-aged men with body image concerns. 112 men with body image concerns were recruited to participate in a randomized controlled trial (RCT), in which they were randomized into either a DB intervention (n=52) or wait list control (WL) condition (n=60).
The investigators hypothesized that: (1) The men in the DB group would show significantly greater reductions on all measures compared to men in the WL group; and (2) Differences between groups would be maintained at 4-week follow-up.
DESIGN Participants Participants (n=112) were recruited through introductory and upper division psychology classes at Florida State University (FSU), through the psychology research participant pool, and advertisements around the campus and local community. Based on retention rates in The PRIDE Body Project, the investigators estimated a 75% retention rate. Analyses support that the expected sample size should provide sufficient power to detect group differences, based on effect sizes from previous DB studies.
Procedure All participants first completed an eligibility phone screen to determine whether they met study eligibility criteria. Participants who qualified for and were interested in participating in the study were directed to complete the online consent form.
This intervention was adapted from a two-session DB intervention that the investigators developed for gay men, which was originally adapted for women to address risk factors specific to males with body image concerns, regardless of sexual orientation. Participants completed baseline measures assessing eating disorder and muscle dysmorphia risk factors, which were selected based on demonstrated reliability and validity in previous studies, particularly for use in men.
The two, 2-hour intervention sessions were spaced one week apart. Intervention groups included 4-10 members each and took place at the FSU psychology building. The investigator and an undergraduate peer co-leader facilitated all intervention groups. During Session 1, participants: (a) defined the male "body-ideal", (b) discussed the origin/perpetuation of the "body-ideal", (c) brainstormed costs of pursuing the "ideal", (d) participated in verbal challenges countering the "body-ideal" message, and (e) were assigned homework assignments. In Session 2 participants: (a) reviewed homework, (b) engaged in role plays to counter pursuit of the "body-ideal" (c) discussed ways to challenge and avoid negative "body talk" (d) listed ways to resist pressures to pursue this ideal both individually and at the university level (termed "body activism") and (e) selected an exit exercise to practice positive body talk. All intervention sessions were audiotaped to ensure facilitator adherence to the protocol.
Baseline measures were repeated for both conditions immediately post-intervention/after a one-week interval and 4-weeks post-intervention/after a five-week interval, to assess immediate and longer-term effects.
Data Analytic Plan The data analytic approach utilized hierarchical linear modeling (HLM), to control for repeated assessments of participants nested within groups.
- Conditions
- Eating Disorder
- Being tested
- The Body Project: More Than Muscles
- Keywords
- prevention, eating disorder, men, intervention, muscle dysmorphia, peer-led
- Medical subject headings
- Feeding and Eating Disorders, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Body Project: More Than MusclesBehavioural
Participants complete a variety of activities designed to counter internalization of the lean, muscular body ideal for men.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist Control | No intervention | Participants in this condition completed assessments at baseline, 1 week, and 5 weeks. |
| The Body Project: More Than Muscles | Experimental | Participants in this condition competed the 2-session dissonance-based eating disorder prevention protocol (2 hours per session). Receives: Behavioral: The Body Project: More Than Muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination Questionnaire - Bulimic Symptoms Composite
Measured: change from baseline to post-intervention (1 week)
Sociocultural Attitudes Towards Appearance Questionnaire-3 - Internalization General subscale
Measured: change from baseline to post-intervention (1 week)
Eating Disorder Examination-Questionnaire Restraint Subscale
Measured: change from baseline to post-intervention (1 week)
Male Body Attitudes Scale
The investigators examined the Muscularity and Body Fat subscales for this study
Measured: change from baseline to post-intervention (1 week)
Drive for Muscularity Scale
Measured: change from baseline to post-intervention (1 week)
Muscle Dysmorphia Disorder Inventory
Measured: change from baseline to post-intervention (1 week)
Secondary outcomes (6)
Eating Disorder Examination Questionnaire - Bulimic Symptoms Composite
Measured: change from baseline to follow-up (5 weeks)
Sociocultural Attitudes Towards Appearance Questionnaire-3 - Internalization General subscale
Measured: change from baseline to follow-up (5 weeks)
Eating Disorder Examination-Questionnaire Restraint Subscale
Measured: change from baseline to follow-up (5 weeks)
Male Body Attitudes Scale
The investigators examined the Muscularity and Body Fat subscales for this study
Measured: change from baseline to follow-up (5 weeks)
Drive for Muscularity Scale
Measured: change from baseline to follow-up (5 weeks)
Muscle Dysmorphia Disorder Inventory
Measured: change from baseline to follow-up (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela K Keel, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013244
- Sponsor's protocol ID
- 2015.17069
- Other IDs
- 2015
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 9 Jan 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of The Body Project: More Than Muscles for Males With Body Dissatisfaction
- ClinicalTrials.gov ID
- NCT03013244
- Acronym / sponsor ID
- 2015.17069
- Conditions
- Eating Disorder
- Keywords
- prevention, eating disorder, men, intervention, muscle dysmorphia, peer-led
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study was to investigate the acceptability and efficacy of a cognitive dissonance-based (DB) intervention in reducing eating disorder and muscle dysmorphia risk factors in men with body dissatisfaction. The investigators hypothesized that the program would reduce eating disorder risk factors to a greater degree compared to wait list control and that these effects would be maintained at 1 month follow-up.
Detailed description
BACKGROUND \& PURPOSE The current project sought to examine the acceptability and efficacy of a cognitive dissonance-based (DB) eating disorder prevention program for college-aged men with body image concerns. Eating disorders represent a public health problem for which efficacious, disseminable treatments largely remain unknown, particularly for males. Epidemiological data support the increasing prevalence of eating disorders and body image concerns among men; however, few programs have been developed to address concerns relevant to men, and many men feel uncomfortable in programs that identify eating disorders as a "female" problem. Given that eating disorders are particularly difficult to treat, disseminable interventions that can target high-risk groups prior to eating disorder onset may be the best way to reduce the public health burden associated with eating disorders. As body image concerns represent the most potent and consistent risk factor for developing eating disorders in males and females, men with body image concerns represent one such high-risk, but underserved, group.
Recent prevention research has used DB principles to challenge thin-ideal internalization to decrease the likelihood of developing an eating disorder in female youth. Additionally, the investigators recently adapted and evaluated a DB program for gay males (The PRIDE Body Project), who represent another high-risk group among men. Dissonance theory states that when individuals engage in counter-attitudinal behavior they experience psychological discomfort, leading them to alter their attitudes to be congruent with their behavior. Several studies have supported the efficacy of DB programs in reducing eating disorder risk among females and results from The PRIDE Body Project extends the efficacy of these programs to gay males. These DB interventions have utilized peer co-leaders, capitalizing on the importance of peer influences on eating behaviors among college-aged females and males.
To date, other than The PRIDE Body Project, no studies have examined eating disorder prevention interventions for high-risk groups of males. Notably, the success of The PRIDE Body Project and several lines of research support that adapting a DB program may also be helpful in reducing eating disorder risk among young men with body image concerns. First, internalization of the mesomorphic ideal plays a central role in risk for developing eating pathology in males. Thus, an intervention targeting internalization of this body ideal may be particularly helpful for males. Second, studies support that peers influence body dissatisfaction and disordered eating in males concurrently and prospectively through socialization. This suggests that men, regardless of sexual orientation, may benefit from a peer-led DB program to address body image concerns. This work could fill a critical gap in the care provided to a growing demographic among those who suffer from eating disorders.
Thus, the aim of the present study was to determine the acceptability and efficacy of adapting a cognitive DB intervention for use in college-aged men with body image concerns. 112 men with body image concerns were recruited to participate in a randomized controlled trial (RCT), in which they were randomized into either a DB intervention (n=52) or wait list control (WL) condition (n=60).
The investigators hypothesized that: (1) The men in the DB group would show significantly greater reductions on all measures compared to men in the WL group; and (2) Differences between groups would be maintained at 4-week follow-up.
DESIGN Participants Participants (n=112) were recruited through introductory and upper division psychology classes at Florida State University (FSU), through the psychology research participant pool, and advertisements around the campus and local community. Based on retention rates in The PRIDE Body Project, the investigators estimated a 75% retention rate. Analyses support that the expected sample size should provide sufficient power to detect group differences, based on effect sizes from previous DB studies.
Procedure All participants first completed an eligibility phone screen to determine whether they met study eligibility criteria. Participants who qualified for and were interested in participating in the study were directed to complete the online consent form.
This intervention was adapted from a two-session DB intervention that the investigators developed for gay men, which was originally adapted for women to address risk factors specific to males with body image concerns, regardless of sexual orientation. Participants completed baseline measures assessing eating disorder and muscle dysmorphia risk factors, which were selected based on demonstrated reliability and validity in previous studies, particularly for use in men.
The two, 2-hour intervention sessions were spaced one week apart. Intervention groups included 4-10 members each and took place at the FSU psychology building. The investigator and an undergraduate peer co-leader facilitated all intervention groups. During Session 1, participants: (a) defined the male "body-ideal", (b) discussed the origin/perpetuation of the "body-ideal", (c) brainstormed costs of pursuing the "ideal", (d) participated in verbal challenges countering the "body-ideal" message, and (e) were assigned homework assignments. In Session 2 participants: (a) reviewed homework, (b) engaged in role plays to counter pursuit of the "body-ideal" (c) discussed ways to challenge and avoid negative "body talk" (d) listed ways to resist pressures to pursue this ideal both individually and at the university level (termed "body activism") and (e) selected an exit exercise to practice positive body talk. All intervention sessions were audiotaped to ensure facilitator adherence to the protocol.
Baseline measures were repeated for both conditions immediately post-intervention/after a one-week interval and 4-weeks post-intervention/after a five-week interval, to assess immediate and longer-term effects.
Data Analytic Plan The data analytic approach utilized hierarchical linear modeling (HLM), to control for repeated assessments of participants nested within groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control | No intervention | –Participants in this condition completed assessments at baseline, 1 week, and 5 weeks. |
| The Body Project: More Than Muscles | Experimental | Behavioral: The Body Project: More Than MusclesParticipants in this condition competed the 2-session dissonance-based eating disorder prevention protocol (2 hours per session). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- male
- do not meet criteria for an eating disorder (based on phone screen interview)
- endorse body image concerns
- 18 years -30 years
- agree to participate in a positive body image program.
Key exclusion criteria (3 listed)
- Individuals under 18 years of age
- Individuals who do not meet criterion a, b, c, or d (as outlined in the inclusion criteria)
- Individuals who meet full criteria for an eating disorder based on responses on the phone screen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Body Project: More Than MusclesParticipants complete a variety of activities designed to counter internalization of the lean, muscular body ideal for men. | Behavioural | The Body Project: More Than Muscles |
Primary outcome
Eating Disorder Examination Questionnaire - Bulimic Symptoms Composite
Time frame: change from baseline to post-intervention (1 week)
Sociocultural Attitudes Towards Appearance Questionnaire-3 - Internalization General subscale
Time frame: change from baseline to post-intervention (1 week)
Eating Disorder Examination-Questionnaire Restraint Subscale
Time frame: change from baseline to post-intervention (1 week)
Male Body Attitudes Scale
Time frame: change from baseline to post-intervention (1 week)
The investigators examined the Muscularity and Body Fat subscales for this study
Drive for Muscularity Scale
Time frame: change from baseline to post-intervention (1 week)
Muscle Dysmorphia Disorder Inventory
Time frame: change from baseline to post-intervention (1 week)
6 secondary outcomes
Eating Disorder Examination Questionnaire - Bulimic Symptoms Composite
Time frame: change from baseline to follow-up (5 weeks)
Sociocultural Attitudes Towards Appearance Questionnaire-3 - Internalization General subscale
Time frame: change from baseline to follow-up (5 weeks)
Eating Disorder Examination-Questionnaire Restraint Subscale
Time frame: change from baseline to follow-up (5 weeks)
Male Body Attitudes Scale
Time frame: change from baseline to follow-up (5 weeks)
Drive for Muscularity Scale
Time frame: change from baseline to follow-up (5 weeks)
Muscle Dysmorphia Disorder Inventory
Time frame: change from baseline to follow-up (5 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela K Keel, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Body Project: More Than Muscles in people with Eating Disorder, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination Questionnaire - Bulimic Symptoms Composite (time frame: change from baseline to post-intervention (1 week)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.