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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04529746
Other study ID # 17-004_1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2016
Est. completion date September 1, 2017

Study information

Verified date August 2021
Source Western Washington University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A pilot randomized-controlled trial explored the feasibility, acceptability, and efficacy of an inclusive dissonance-based body image intervention called the EVERYbody Project. The professionally delivered EVERYbody Project was evaluated in a universal college student population compared to a waitlist control group through one-month follow-up.


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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date September 1, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Current college student enrolled at institution where research was taking place Exclusion Criteria: - None

Study Design


Intervention

Behavioral:
EVERYbody Project
Brief behavioral intervention (4 hours across two meetings)

Locations

Country Name City State
United States Western Washington University Bellingham Washington

Sponsors (1)

Lead Sponsor Collaborator
Western Washington University

Country where clinical trial is conducted

United States, 

References & Publications (9)

Berscheid, E., Hatfield [Walster], E., & Bohrnstedt, G. (1973). The happy American body: A survey report. Psychology Today, 7, 119-131.

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. — View Citation

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):301-3 — View Citation

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. — View Citation

Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Other Open-ended interviews Students with marginalized identities who participated in EVERYbody Project groups were invited to complete semi-structured interviews. Specific question asked were:
How was your experience with the EVERYbody Project?
Was anything in the program (any activity or part of the experience) particularly interesting or helpful to you? Why?
Was anything in the program (any activity or part of the experience) particularly unhelpful or upsetting to you? Why?
(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.
Other Program satisfaction and application: questions included four Likert scale 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).
Primary Eating disorder symptoms 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). 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.
Primary Body dissatisfaction: The Satisfaction and Dissatisfaction with Body Parts Scale 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). 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.
Primary Internalized cultural appearance norms 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). 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 Negative affect 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. 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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