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Pilot Evaluation of the EVERYbody Project

Primary Purpose

Body Image, Eating Disorder Symptom

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EVERYbody Project
Sponsored by
Western Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Image

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Current college student enrolled at institution where research was taking place

Exclusion Criteria:

  • None

Sites / Locations

  • Western Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EVERYbody Project: Professional facilitator version

Waitlist control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
August 15, 2020
Last Updated
August 5, 2021
Sponsor
Western Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT04529746
Brief Title
Pilot Evaluation of the EVERYbody Project
Official Title
A Pilot Evaluation of the EVERYbody Project: Professionally-delivered Inclusive Eating Disorder Risk Factor Reduction for College Students
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Washington University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Image, Eating Disorder Symptom

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Participants were randomized on a 1-1 basis to receive either the EVERYbody Project or be on the waitlist control list (assessment-only control).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVERYbody Project: Professional facilitator version
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EVERYbody Project
Intervention Description
Brief behavioral intervention (4 hours across two meetings)
Primary Outcome Measure Information:
Title
Eating disorder symptoms
Description
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).
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.
Title
Body dissatisfaction: The Satisfaction and Dissatisfaction with Body Parts Scale
Description
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).
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.
Title
Internalized cultural appearance norms
Description
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).
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.
Secondary Outcome Measure Information:
Title
Negative affect
Description
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.
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.
Other Pre-specified Outcome Measures:
Title
Open-ended interviews
Description
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.
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.
Title
Program satisfaction and application: questions included four Likert scale
Description
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.
Time Frame
Assessed at post-intervention (Survey 2; immediately following the intervention) and one-month follow-up (Survey 3; four weeks post intervention).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Current college student enrolled at institution where research was taking place Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna C Ciao, PhD
Organizational Affiliation
Western Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Washington University
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Since the trial is complete, data are available immediately upon request.
IPD Sharing URL
https://osf.io/x3k7v/?view_only=c9dbd31a4ad94a08b16421d719bc0fac
Citations:
PubMed Identifier
29105805
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.
Results Reference
background
PubMed Identifier
7866415
Citation
Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
Results Reference
background
PubMed Identifier
25285718
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.
Results Reference
background
PubMed Identifier
16649871
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.
Results Reference
background
Citation
Berscheid, E., Hatfield [Walster], E., & Bohrnstedt, G. (1973). The happy American body: A survey report. Psychology Today, 7, 119-131.
Results Reference
background
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
Results Reference
background
PubMed Identifier
25959408
Citation
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.
Results Reference
background
PubMed Identifier
27188688
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.
Results Reference
background
PubMed Identifier
34014692
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.
Results Reference
result

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Pilot Evaluation of the EVERYbody Project

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