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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05336253
Other study ID # 4482EX21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 14, 2022
Est. completion date August 30, 2023

Study information

Verified date December 2023
Source Western Washington University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized-controlled trial examines an online dissonance-based body image program for college students called the EVERYbody Project-Connect. The online (videoconferencing) intervention will be delivered using expert peer leaders in three 90-minute weekly sessions. Expert peer leaders for the EVERYbody Project-Connect are college students with lived and/or academic expertise within both body image and diversity and equity domains who are trained and screened for facilitation readiness. The comparison intervention is a passive, time-matched self-help condition using The Body Is Not An Apology Workbook by Sonya Renee Taylor. Both interventions explore diversity and representation within sociocultural body image pressures and provide tools for body acceptance. The study is open to all college students in a universal prevention and risk factor reduction framework. Outcomes will be assessed before and after the three weeks of intervention and at three-month follow-up.


Description:

To date, three completed trials of the EVERYbody Project demonstrate that a gender-inclusive, diversity-focused, dissonance based group program can improve eating disorder risk factors and body image among college students. Through active written and verbal exercises and discussion, students directly challenge the cultural messages that appearance should fit within a narrow set of "ideals," critiquing the diversity representation within appearance ideals and incorporating new strategies for body acceptance. Although peer (aka student to student) facilitation is commonly used for delivering dissonance-based body image interventions, an open training model (where all interested students are eligible to facilitate after training) may not be the most beneficial for leading inclusivity-focused body image groups. Research suggests that the EVERYbody Project is most effective when delivered by either (1) professional facilitators (faculty or staff with body image expertise), or (2) expert peer leaders (college students with lived or academic expertise in both body image and diversity topics who are screened for facilitation readiness during training). The current trial explores an online adaptation of this program. The EVERYbody Project-Connect was created from the original program after end-user piloting with college students. The resulting program consists of three 90-minute weekly sessions delivered by expert peer leaders over a secure videoconferencing platform. Expert peer facilitators will complete a 16-hour online training and be screened for facilitation readiness before being approved to lead the intervention. Participants will be randomized on a 1:1 basis to receive the EVERYbody Project-Connect or a time-matched, low-dissonance self-help workbook intervention. Participants in this comparison intervention will be provided with an online copy of The Body Is Not An Apology Workbook by author and activist Sonya Renee Taylor and given weekly assignment instructions (90 minutes of activities each week for three weeks). Workbook activities will be completed on their own as a passive self-help intervention. College students in the Pacific Northwest United States will be invited to participate in this study (universal intervention target, gender inclusive). Outcome assessment includes a comparison of changes in eating disorder risk factors, eating disorder symptoms, and related constructs across conditions over time (from pre- to post-intervention and through 3-month follow-up). Program satisfaction will be assessed at post-intervention, and program application will be evaluated both post-intervention and at follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Current college students (enrolled with university email address) Exclusion Criteria: - None

Study Design


Intervention

Behavioral:
EVERYbody Project-Connect
3-week dissonance-based, group, online body image program (4.5 hours total)
Self-Help Workbook
Time-matched 3-week passive, individual workbook condition (4.5 hours total)

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 (13)

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, 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):301-315. 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

Crandall, C., & Biernat, M. (1990). The Ideology of Anti-Fat Attitudes. Journal of Applied Social Psychology, 20(3), 227-243.

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. — View Citation

Kliem S, Mossle T, Zenger M, Strauss B, Brahler E, Hilbert A. The eating disorder examination-questionnaire 8: A brief measure of eating disorder psychopathology (EDE-Q8). Int J Eat Disord. 2016 Jun;49(6):613-6. doi: 10.1002/eat.22487. Epub 2015 Dec 29. — 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. doi: 10.1037/0022-006X.74.2.263. — View Citation

Taylor, S. R. (2021). The Body Is Not An Apology Workbook: Tools for Living Radical Self-Love. Beret-Koehler Publishers, Inc.

Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21. — 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

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Week 1 weight bias change Interim assessment of weight bias after Week 1 of the 3-week interventions using the Anti-fat attitudes scale (AFAS). Change from baseline to Week 1 will be used to predict post-intervention and follow-up outcomes. Assessed at Week 1 of intervention (one week after baseline)
Other Week 1 internalization change Interim assessment of internalization of appearance norms after Week 1 of the 3-week interventions using the Sociocultural Attitudes Toward Appearance Questionnaire-4 (SATAQ-4). Change from baseline to Week 1 will be used to predict post-intervention and follow-up outcomes. Assessed at Week 1 of intervention (one week after baseline)
Other Program satisfaction Four Likert scale items about enjoyment (e.g., "I enjoyed the EVERYbody Project") averaged for total satisfaction score (higher score equals greater satisfaction). Three open-ended questions (e.g., "Was any part of the EVERYbody Project particularly helpful/useful? If so, which part and why?") coded for themes. Assessed at post-intervention (three weeks after baseline)
Other Program application Three Likert questions to gauge the application of new information (e.g., "How often do you think about the things you learned in the EVERYbody Project?"). Items will be averaged for a total application score (higher scores equaling more frequent application). One open-ended question on the 3-month follow-up survey only to report any other ways the EVERYbody Project has impacted the participant recently. Assessed at post-intervention (three weeks after baseline) and follow-up (3 months)
Primary Internalized appearance norms Internalization subscales from the Sociocultural Attitudes Toward Appearance Questionnaire-4 (SATAQ-4). Average of 10 items; higher scores indicate greater internalization of cultural messages surrounding appearance and attractiveness. Change from baseline through post-intervention (3 weeks later) and follow-up (3 months)
Primary Body dissatisfaction Satisfaction and Dissatisfaction with Body Parts Scale (SDBPS). Average of 9 items; higher scores equal greater dissatisfaction with nine body parts that are commonly endorsed as concerning (e.g., stomach, thighs, hips). The scale will be reverse scored from the original. Change from baseline through post-intervention (3 weeks later) and follow-up (3 months)
Primary Eating disorder pathology 8-item version of the Eating Disorders Examination Questionnaire (EDE-Q8). Average of 8 items for Global Score; higher scores equal greater frequency and severity of disordered attitudes and behaviors over the past month. Change from baseline through post-intervention (3 weeks later) and follow-up (3 months)
Primary Negative affect Fear, guilt, and sadness subscales of the Positive and Negative Affect Schedule-Revised (PANAS). Average of 20 items; higher scores equal greater negative emotion. Change from baseline through post-intervention (3 weeks later) and follow-up (3 months)
Secondary Weight bias Anti-fat attitudes scale (AFAS). Average of 5 items; higher scores equal greater negative stereotypes about fat people and fear of fat. Change from baseline through post-intervention (3 weeks later) and follow-up (3 months)
Secondary Positive body image Body Appreciation Scale-2 (BAS-2). Average of 10 items; higher scores equal greater body positivity. Change from baseline through post-intervention (3 weeks later) and follow-up (3 months)
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