Evaluation of Peer-led EVERYbody Project

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

EVERYbody Project

Video + Expressive Writing

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

Active Comparator

Arm Label

EVERYbody Project: Peer facilitator version

Video + Expressive Writing group

Arm Description

This dissonance-based body image program was created from focus group feedback (Ciao, Ohls, & Pringle, 2017) and piloted in an initial randomized-controlled trial. Based on the Body Project (Stice et al., 2006), it retains key dissonance activities while adapting exercises to have a more inclusive focus (e.g., expanding the gender focus, exploring diversity characteristics within appearance ideals, adjusting activities to be inclusive of diversity). Around 10% of the original EVERYbody Project manual was modified to create the Peer Facilitator version for the current trial. Changes focused on adding individual exercises to draw out the critique of diversity in cultural ideals, refining prompts to be more suitable for peer facilitation, and flagging sections of the manual for more "expert" peer facilitation. Peer facilitators received 16 hours of training on the EVERYbody Project manual and peer facilitation guidelines (e.g., group management, handling problems, etc.).

Video + expressive writing groups were facilitated by a peer leader following a detailed script. This intervention was designed as an active but low-dissonance comparison condition. Participants viewed two separate documentary movies related to gender and/or appearance-related pressures (one during each session): (1) The Illusionists (2015 ), and (2) The Mask You Live In (2015). Participants engaged in a brief (10 minute) reflective writing exercise after each film. In order to keep dissonance low, participants were told that their reflections would not be shared with anyone and they were not turned in. Peer facilitators received brief (1 hour) training on the video group manual.

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).

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).

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).

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.

Full Information

NCT ID

NCT04517942

First Posted

August 15, 2020

Last Updated

August 5, 2021

Sponsor

Western Washington University

1. Study Identification

Unique Protocol Identification Number

NCT04517942

Brief Title

Evaluation of Peer-led EVERYbody Project

Official Title

An Evaluation of the Peer-delivered EVERYbody Project: 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, 2017 (Actual)

Primary Completion Date

September 1, 2018 (Actual)

Study Completion Date

September 1, 2018 (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

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.

Detailed 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.

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

After signing up for a specific time slot, participants were randomized in blocks of 10 to the EVERYbody Project or video comparison condition (two blocks of 10 participant slots were available in each time slot).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

141 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EVERYbody Project: Peer facilitator version

Arm Type

Experimental

Arm Description

This dissonance-based body image program was created from focus group feedback (Ciao, Ohls, & Pringle, 2017) and piloted in an initial randomized-controlled trial. Based on the Body Project (Stice et al., 2006), it retains key dissonance activities while adapting exercises to have a more inclusive focus (e.g., expanding the gender focus, exploring diversity characteristics within appearance ideals, adjusting activities to be inclusive of diversity). Around 10% of the original EVERYbody Project manual was modified to create the Peer Facilitator version for the current trial. Changes focused on adding individual exercises to draw out the critique of diversity in cultural ideals, refining prompts to be more suitable for peer facilitation, and flagging sections of the manual for more "expert" peer facilitation. Peer facilitators received 16 hours of training on the EVERYbody Project manual and peer facilitation guidelines (e.g., group management, handling problems, etc.).

Arm Title

Video + Expressive Writing group

Arm Type

Active Comparator

Arm Description

Video + expressive writing groups were facilitated by a peer leader following a detailed script. This intervention was designed as an active but low-dissonance comparison condition. Participants viewed two separate documentary movies related to gender and/or appearance-related pressures (one during each session): (1) The Illusionists (2015 ), and (2) The Mask You Live In (2015). Participants engaged in a brief (10 minute) reflective writing exercise after each film. In order to keep dissonance low, participants were told that their reflections would not be shared with anyone and they were not turned in. Peer facilitators received brief (1 hour) training on the video group manual.

Intervention Type

Behavioral

Intervention Name(s)

EVERYbody Project

Intervention Description

Brief behavioral intervention (4 hours across two meetings)

Intervention Type

Other

Intervention Name(s)

Video + Expressive Writing

Intervention Description

Brief video-based 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).

Time Frame

Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)

Title

Body dissatisfaction

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).

Time Frame

Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)

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), 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).

Time Frame

Assessed at baseline (Survey 1), following intervention Session 1 (Survey 1.B), post-intervention (Survey 2), and one-month follow-up (Survey 3)

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.

Time Frame

Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)

Other Pre-specified Outcome Measures:

Title

Program satisfaction and application

Description

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).

Time Frame

Assessed at post-intervention (Survey 2) and one-month follow-up (Survey 3).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

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

Body Image, Eating Disorder Symptom

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial