- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04517942
Evaluation of Peer-led EVERYbody Project
An Evaluation of the Peer-delivered EVERYbody Project: Eating Disorder Risk Factor Reduction for College Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Washington
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Bellingham, Washington, United States, 98225
- Western Washington University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Current college student enrolled at institution where research was taking place
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EVERYbody Project: Peer facilitator version
This dissonance-based body image program was created from focus group feedback (Ciao, Ohls, & Pringle, 2017) and piloted in an initial randomized-controlled trial. Based on the Body Project (Stice et al., 2006), it retains key dissonance activities while adapting exercises to have a more inclusive focus (e.g., expanding the gender focus, exploring diversity characteristics within appearance ideals, adjusting activities to be inclusive of diversity). Around 10% of the original EVERYbody Project manual was modified to create the Peer Facilitator version for the current trial. Changes focused on adding individual exercises to draw out the critique of diversity in cultural ideals, refining prompts to be more suitable for peer facilitation, and flagging sections of the manual for more "expert" peer facilitation. Peer facilitators received 16 hours of training on the EVERYbody Project manual and peer facilitation guidelines (e.g., group management, handling problems, etc.). |
Brief behavioral intervention (4 hours across two meetings)
|
|
Active Comparator: Video + Expressive Writing group
Video + expressive writing groups were facilitated by a peer leader following a detailed script. This intervention was designed as an active but low-dissonance comparison condition. Participants viewed two separate documentary movies related to gender and/or appearance-related pressures (one during each session): (1) The Illusionists (2015 ), and (2) The Mask You Live In (2015). Participants engaged in a brief (10 minute) reflective writing exercise after each film. In order to keep dissonance low, participants were told that their reflections would not be shared with anyone and they were not turned in. Peer facilitators received brief (1 hour) training on the video group manual. |
Brief video-based intervention (4 hours across two meetings)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating disorder symptoms
Time Frame: Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)
|
Eating disorder symptoms were assessed with the Eating Disorders Examination Questionnaire (EDEQ; Fairburn & Beglin, 1994).
The Global score of the EDEQ was used in this study (average across all 28 items).
|
Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)
|
|
Body dissatisfaction
Time Frame: Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)
|
The Satisfaction and Dissatisfaction with Body Parts Scale (SDBPS; Berscheid, Walster, & Bohrnstedt, 1973) assessed satisfaction and dissatisfaction with nine parts of the body that are commonly endorsed as concerning (e.g., stomach, thighs, hips).
The average score was used in this study (average across all 9 items).
|
Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)
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Internalized cultural appearance norms
Time Frame: Assessed at baseline (Survey 1), following intervention Session 1 (Survey 1.B), post-intervention (Survey 2), and one-month follow-up (Survey 3)
|
The two Internalization subscales of the Sociocultural Attitudes Toward Appearance Questionnaire-4 (SATAQ-4; Schaefer et al., 2015) assess internalized cultural messages surrounding appearance and attractiveness.
The two internalization subscales were combined for this study (average across all 10 items), following prior research by Kilpela et al. (2016).
This survey was assessed at all outcome time points (Survey 1, 2, and 3), plus midway through the intervention (following Session 1 of the program).
|
Assessed at baseline (Survey 1), following intervention Session 1 (Survey 1.B), post-intervention (Survey 2), and one-month follow-up (Survey 3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Negative affect
Time Frame: Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)
|
Negative affect was assessed with 20 items from the fear, guilt, and sadness subscales of the Positive and Negative Affect Schedule-Revised (PANAS-X; Watson & Clark, 1992).
The average of all 20 items was used in this study.
|
Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Program satisfaction and application
Time Frame: Assessed at post-intervention (Survey 2) and one-month follow-up (Survey 3).
|
A series of feedback questions were used to gauge satisfaction with the EVERYbody Project (based on Ciao et al., 2015). These questions included four Likert scale items about enjoyment (e.g., "I enjoyed the EVERYbody Project") rated from 1 (strongly disagree) to 5 (strongly agree) as well as open-ended questions (e.g., "Was any part of the EVERYbody Project particularly helpful/useful? If so, which part and why?") These questions were administered immediately following participation in the EVERYbody Project as a part of the post-intervention survey (Survey 2). At post-intervention (Survey 2) and one-month follow-up (Survey 3), three questions gauged application of information learned in the program (e.g., "How often do think about the things you learned in the EVERYbody Project?" rated on a scale from 1 (not at all) to 5 (all the time). |
Assessed at post-intervention (Survey 2) and one-month follow-up (Survey 3).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
- Stice E, Shaw H, Burton E, Wade E. Dissonance and healthy weight eating disorder prevention programs: a randomized efficacy trial. J Consult Clin Psychol. 2006 Apr;74(2):263-75. doi: 10.1037/0022-006X.74.2.263.
- Schaefer LM, Burke NL, Thompson JK, Dedrick RF, Heinberg LJ, Calogero RM, Bardone-Cone AM, Higgins MK, Frederick DA, Kelly M, Anderson DA, Schaumberg K, Nerini A, Stefanile C, Dittmar H, Clark E, Adams Z, Macwana S, Klump KL, Vercellone AC, Paxton SJ, Swami V. Development and validation of the Sociocultural Attitudes Towards Appearance Questionnaire-4 (SATAQ-4). Psychol Assess. 2015 Mar;27(1):54-67. doi: 10.1037/a0037917. Epub 2014 Oct 6.
- Ciao AC, Ohls OC, Pringle KD. Should body image programs be inclusive? A focus group study of college students. Int J Eat Disord. 2018 Jan;51(1):82-86. doi: 10.1002/eat.22794. Epub 2017 Nov 6.
- Berscheid, E., Hatfield [Walster], E., & Bohrnstedt, G. (1973). The happy American body: A survey report. Psychology Today, 7, 119-131.
- Watson, D., & Clark, L. A. (1992). Affects separable and inseparable: On the hierarchical arrangement of the negative affects. Journal of Personality and Social Psychology, 62, 489-505. http://dx.doi.org/10.1037/ 0022-3514.62.3.489
- Ciao AC, Latner JD, Brown KE, Ebneter DS, Becker CB. Effectiveness of a peer-delivered dissonance-based program in reducing eating disorder risk factors in high school girls. Int J Eat Disord. 2015 Sep;48(6):779-84. doi: 10.1002/eat.22418. Epub 2015 May 8.
- Kilpela LS, Blomquist K, Verzijl C, Wilfred S, Beyl R, Becker CB. The body project 4 all: A pilot randomized controlled trial of a mixed-gender dissonance-based body image program. Int J Eat Disord. 2016 Jun;49(6):591-602. doi: 10.1002/eat.22562. Epub 2016 May 18.
- Ciao AC, Munson BR, Pringle KD, Roberts SR, Lalgee IA, Lawley KA, Brewster J. Inclusive dissonance-based body image interventions for college students: Two randomized-controlled trials of the EVERYbody Project. J Consult Clin Psychol. 2021 Apr;89(4):301-315. doi: 10.1037/ccp0000636.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-004_2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Data and other materials will be made available following reasonable request to study Principal Investigator. All outcome data will be included in data sharing. Socio-demographic characteristics will be collapsed into broader categories to protect participant identity.
Other study materials, including intervention manuals, will be housed on the Principal Investigator's Open Science Framework page, where URLs will be made publicly available.
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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