- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04529746
Pilot Evaluation of the EVERYbody Project
A Pilot Evaluation of the EVERYbody Project: Professionally-delivered Inclusive Eating Disorder Risk Factor Reduction for College Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
An existing dissonance-based body image program (the Body Project; Stice, Shaw, Burton, & Wade, 2006) was adapted to directly discuss diversity within cultural appearance ideals (including race, gender identity, sexuality, ability, and age) and the individual and collective impact of pursuing exclusive appearance norms.
The feasibility, acceptability, and efficacy of the EVERYbody Project was assessed in an initial randomized-controlled trial. College students within a university in the Pacific Northwest United States were invited to participate in programming (universal intervention target).
Professional delivery of the two-session EVERYbody Project was compared to a waitlist control condition. Intervention groups were facilitated by one "expert" (faculty or staff with body image expertise) and two college student co-facilitators. Mixed methods assessment included a comparison of changes in quantitative eating disorder risk factor outcomes across randomization conditions and among students with marginalized identities at pre-intervention, post-intervention, and one-month follow-up. Qualitative interviews assessed the impact of the program on participants with marginalized identities. Feasibility and acceptability of the program was assessed to evaluate the appropriateness of the EVERYbody Project within universal college student audiences.
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: EVERYbody Project: Professional facilitator version
The EVERYbody Project is a dissonance body image intervention created from focus group feedback (Ciao, Ohls, & Pringle, 2017) and through an iterative process of student-driven feedback. The Body Project manual (Stice et al., 2006) was adapted to retain key dissonance activities while expanding the gender focus, adding an exploration of the diversity characteristics within appearance ideals, and adjusting activities to be inclusive of diversity characteristics. Several adapted versions of the intervention were piloted with groups of college students and further adapted based on feedback. Facilitators received 16 hours of training on the EVERYbody Project manual and facilitation guidelines. |
Brief behavioral intervention (4 hours across two meetings)
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NO_INTERVENTION: Waitlist control group
Participants allocated to the waitlist completed assessments at time points parallel to those in the EVERYbody Project condition and were offered the EVERYbody Project upon completing the one-month follow-up assessment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating disorder symptoms
Time Frame: Assessed change from baseline (Survey 1) through post-intervention (Survey 2; immediately after intervention) and one-month follow-up (Survey 3; one month after intervention). Waitlist was assessed at parallel time points.
|
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 with a 0-6 range; higher scores equal greater eating disorder symptoms).
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Assessed change from baseline (Survey 1) through post-intervention (Survey 2; immediately after intervention) and one-month follow-up (Survey 3; one month after intervention). Waitlist was assessed at parallel time points.
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Body dissatisfaction: The Satisfaction and Dissatisfaction with Body Parts Scale
Time Frame: Assessed change from baseline (Survey 1) through post-intervention (Survey 2; immediately after intervention) and one-month follow-up (Survey 3; one month after intervention). Waitlist was assessed at parallel time points.
|
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 with 1-5 range; higher scores equal greater body dissatisfaction).
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Assessed change from baseline (Survey 1) through post-intervention (Survey 2; immediately after intervention) and one-month follow-up (Survey 3; one month after intervention). Waitlist was assessed at parallel time points.
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Internalized cultural appearance norms
Time Frame: Assessed change from baseline (Survey 1) through post-intervention (Survey 2; immediately after intervention) and one-month follow-up (Survey 3; one month after intervention). Waitlist was assessed at parallel time points.
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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 with 1-5 range; higher scores equal greater internalization), following prior research by Kilpela et al. (2016).
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Assessed change from baseline (Survey 1) through post-intervention (Survey 2; immediately after intervention) and one-month follow-up (Survey 3; one month after intervention). Waitlist was assessed at parallel time points.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Negative affect
Time Frame: Assessed change from baseline (Survey 1) through post-intervention (Survey 2; immediately after intervention) and one-month follow-up (Survey 3; one month after intervention). Waitlist was assessed at parallel time points.
|
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 with 1-5 range; higher scores equal greater negative affect.
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Assessed change from baseline (Survey 1) through post-intervention (Survey 2; immediately after intervention) and one-month follow-up (Survey 3; one month after intervention). Waitlist was assessed at parallel time points.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Open-ended interviews
Time Frame: Students are invited to participate after completing their follow-up survey (Survey 3) or one month after their participation in the EVERYbody Project.
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Students with marginalized identities who participated in EVERYbody Project groups were invited to complete semi-structured interviews. Specific question asked were:
(3) The goal of this research was to have conversations about body image that are more inclusive, that is, with diverse individuals who have many different experiences. Do you think this occurred within your EVERYbody Project group? (4) Is there anything you would suggest for improving EVERYbody Project groups to meet the goal stated above? (5) Is there anything else you would like to share with us about the EVERYbody Project? Additional follow-up prompts were used at the interviewer's discretion. |
Students are invited to participate after completing their follow-up survey (Survey 3) or one month after their participation in the EVERYbody Project.
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Program satisfaction and application: questions included four Likert scale
Time Frame: Assessed at post-intervention (Survey 2; immediately following the intervention) and one-month follow-up (Survey 3; four weeks post intervention).
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Satisfaction with the EVERYbody Project (based on Ciao et al., 2015) included four Likert scale items (e.g., "I enjoyed the EVERYbody Project") rated from 1 (strongly disagree) to 5 (strongly agree). Questions were averaged to create a total "satisfaction" score; higher scores equaled greater satisfaction. Open-ended questions also assessed satisfaction (e.g., "Was any part of the EVERYbody Project particularly helpful/useful? If so, which part and why?"). Satisfaction questions were administered immediately following participation in the intervention (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). Items were averaged to created a total "application" score with higher scores equaling greater application of intervention content. |
Assessed at post-intervention (Survey 2; immediately following the intervention) and one-month follow-up (Survey 3; four weeks post intervention).
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
- 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.
- 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.
- 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_1
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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