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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04517942
Other study ID # 17-004_2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date September 1, 2018

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

The second trial of the EVERYbody Project explored the efficacy of the inclusive body image intervention when delivered by college peer leaders. The peer-facilitated EVERYbody Project was compared to a video and expressive writing comparison intervention through one-month follow-up.


Description:

The initial trial of the EVERYbody Project established that professional leaders could deliver a universal, inclusive body image program for college students, with benefit above and beyond a waitlist control condition. The second trial of the EVERYbody Project aimed to further evaluate the intervention using a more disseminable facilitator model: trained college student peer leaders. It also utilized a more rigorous comparison condition, where peer leaders conducted the two-session EVERYbody Project program or a time-matched video and expressive writing intervention. College students within a university in the Pacific Northwest United States were invited to participate in programming (universal intervention target). Quantitative assessment included a comparison of changes in eating disorder risk factor outcomes across randomization conditions at pre- and post-intervention and one-month follow-up. Feasibility and acceptability explored the impact of the peer delivered program within universal college student audiences.


Recruitment information / eligibility

Status Completed
Enrollment 141
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
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)
Other:
Video + Expressive Writing
Brief video-based 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 Program satisfaction and application 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).
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). Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)
Primary Body dissatisfaction 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)
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), 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 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. Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)
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