NCT03013244

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

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

Study Start

First participant enrolled

September 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
Last Updated

January 9, 2017

Status Verified

December 1, 2016

Enrollment Period

1.1 years

First QC Date

December 20, 2016

Last Update Submit

January 5, 2017

Conditions

Eating Disorder

Keywords

preventioneating disordermeninterventionmuscle dysmorphiapeer-led

Outcome Measures

Primary Outcomes (6)

  • Eating Disorder Examination Questionnaire - Bulimic Symptoms Composite

    change from baseline to post-intervention (1 week)

  • Sociocultural Attitudes Towards Appearance Questionnaire-3 - Internalization General subscale

    change from baseline to post-intervention (1 week)

  • Eating Disorder Examination-Questionnaire Restraint Subscale

    change from baseline to post-intervention (1 week)

  • Male Body Attitudes Scale

    The investigators examined the Muscularity and Body Fat subscales for this study

    change from baseline to post-intervention (1 week)

  • Drive for Muscularity Scale

    change from baseline to post-intervention (1 week)

  • Muscle Dysmorphia Disorder Inventory

    change from baseline to post-intervention (1 week)

Secondary Outcomes (6)

  • Eating Disorder Examination Questionnaire - Bulimic Symptoms Composite

    change from baseline to follow-up (5 weeks)

  • Sociocultural Attitudes Towards Appearance Questionnaire-3 - Internalization General subscale

    change from baseline to follow-up (5 weeks)

  • Eating Disorder Examination-Questionnaire Restraint Subscale

    change from baseline to follow-up (5 weeks)

  • Male Body Attitudes Scale

    change from baseline to follow-up (5 weeks)

  • Drive for Muscularity Scale

    change from baseline to follow-up (5 weeks)

  • +1 more secondary outcomes

Study Arms (2)

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).

Behavioral: The Body Project: More Than Muscles

Interventions

The Body Project: More Than MusclesBEHAVIORAL

Participants complete a variety of activities designed to counter internalization of the lean, muscular body ideal for men.

The Body Project: More Than Muscles

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • do not meet criteria for an eating disorder (based on phone screen interview)
  • endorse body image concerns
  • years -30 years
  • agree to participate in a positive body image program.

You may not qualify if:

  • Individuals under 18 years of age
  • Individuals who meet full criteria for an eating disorder based on responses on the phone screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Feeding and Eating DisordersMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Pamela K Keel, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

January 6, 2017

Study Start

September 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 9, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)