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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05030532
Other study ID # 17-004_3
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date June 30, 2020

Study information

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

Clinical Trial Summary

The third trial of the EVERYbody Project explored the efficacy of using expert peer leaders to deliver the two-session, inclusive, group body image intervention compared to a time-matched video and expressive writing group through three-month follow-up. Expert peer leaders were college students with lived and/or academic expertise who were screened for facilitation readiness through a two-day training.


Description:

The first two trials of the EVERYbody Project demonstrated that a gender-inclusive, diversity-focused, dissonance-based group body image intervention could improve eating disorder risk factors among college students, particularly when the two session program was delivered by individuals with expertise (faculty or staff with body image expertise). When peer interventionists were used (college students with body image interest who completed a two-day training before facilitating groups), the effects of the EVERYbody Project were diminished. Although peer facilitation is commonly used for delivering dissonance-based body image interventions, an open training peer facilitation model (where all students who are trained are eligible to deliver the intervention) may not be the most beneficial for leading inclusivity-focused body image groups. The current trial of the EVERYbody Project (Trial 3) explores a novel strategy to implement this program using expert peer facilitators. College students with lived or academic expertise in both body image and diversity topics were recruited to complete a two-day training. The training included practice and feedback on the two session intervention content as well as training on inclusive facilitation. Following the training, peer leaders completed a facilitation readiness self-evaluation and were evaluated by trainers for facilitation expertise. Only students who passed the expertise threshold were invited to facilitate EVERYbody Project groups. The expert peer facilitation of the EVERYbody Project was compared to a time-matched two session passive video and expressive writing intervention. College students within a university in the Pacific Northwest United States were invited to participate in the group intervention (universal intervention target, gender inclusive). Outcome assessment included a comparison of changes in eating disorder risk factors and symptoms across randomization conditions from pre-post intervention through three-month follow-up. Program satisfaction was assessed at post-intervention and program application was assessed post-intervention and at three-month follow-up.


Recruitment information / eligibility

Status Terminated
Enrollment 84
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
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 group intervention (4 hours across two meetings)
Other:
Video + Expressive Writing
Brief video-based group 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 (10)

Becker CB, Stice E. From efficacy to effectiveness to broad implementation: Evolution of the Body Project. J Consult Clin Psychol. 2017 Aug;85(8):767-782. doi: 10.1037/ccp0000204. — View Citation

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

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. — 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

Kliem S, Schmidt R, Vogel M, Hiemisch A, Kiess W, Hilbert A. An 8-item short form of the Eating Disorder Examination-Questionnaire adapted for children (ChEDE-Q8). Int J Eat Disord. 2017 Jun;50(6):679-686. doi: 10.1002/eat.22658. Epub 2017 Jan 25. — 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 after the second session (based on prior research). 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 as a part of the post-intervention survey (Survey 2).
At post-intervention (Survey 2) and three-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 (1-2 weeks after baseline) and follow-up (3 months)
Primary Eating disorder symptoms Eating disorder symptoms were assessed with an 8-item version of the Eating Disorders Examination Questionnaire (EDEQ). The 8-item version of the EDEQ yields a Global score (average across all 8 items). Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
Primary Body Dissatisfaction The Satisfaction and Dissatisfaction with Body Parts Scale (SDBPS) 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). Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
Primary Internalized cultural appearance norms The two Internalization subscales of the Sociocultural Attitudes Toward Appearance Questionnaire-4 (SATAQ-4) 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. 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). Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
Primary 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). The average of all 20 items was used in this study. Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
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