Body ImageNCT04517942

Evaluation of Peer-led EVERYbody Project

A study testing EVERYbody Project and Video + Expressive Writing in people with Body Image and Eating Disorder Symptom, run by Western Washington University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Body Image, Eating Disorder Symptom
What is being tested?: EVERYbody Project and Video + Expressive Writing
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 141 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2017to 1 Sep 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Current college student enrolled at institution where research was taking place

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Western Washington University
Bellingham, Washington, 98225

Other trials in United States

About this study

Official title: An Evaluation of the Peer-delivered EVERYbody Project: Eating Disorder Risk Factor Reduction for College Students

Read the 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.

Conditions: Body Image, Eating Disorder Symptom
Being tested: EVERYbody Project, Video + Expressive Writing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EVERYbody ProjectBehavioural
Brief behavioral intervention (4 hours across two meetings)
Video + Expressive WritingOther
Brief video-based intervention (4 hours across two meetings)

Study groups in NCT04517942
Study group	Role	What they receive
EVERYbody Project: Peer facilitator version	Experimental	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.). Receives: Behavioral: EVERYbody Project
Video + Expressive Writing group	Active comparator	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. Receives: Other: Video + Expressive Writing

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20171 Sep 2018

First posted19 Aug 2020
Study start1 Oct 2017
Primary completion1 Sep 2018
Study completion1 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Body ImageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
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)
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04517942
Sponsor's protocol ID: 17-004_2
Status last verified: Aug 2021
First submitted: 15 Aug 2020
Last updated: 12 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 29105805
Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
PubMed 7866415
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.
PubMed 25285718
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.
PubMed 16649871
Berscheid, E., Hatfield [Walster], E., & Bohrnstedt, G. (1973). The happy American body: A survey report. Psychology Today, 7, 119-131.
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
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.
PubMed 25959408
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.
PubMed 27188688
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.
PubMed 34014692

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the Peer-delivered EVERYbody Project: Eating Disorder Risk Factor Reduction for College Students
ClinicalTrials.gov ID: NCT04517942
Acronym / sponsor ID: 17-004_2
Conditions: Body Image, Eating Disorder Symptom
Study type: Interventional
Recruitment status: Completed
Enrolment: 141 participants (actual)
Lead sponsor: Western Washington UniversityUniversity, hospital or other
Study start: 1 Oct 2017 (actual)
Primary completion: 1 Sep 2018 (actual)
Study completion: 1 Sep 2018 (actual)
First posted: 19 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2
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).

Arm	Type	Receives
EVERYbody Project: Peer facilitator version	Experimental	Behavioral: EVERYbody ProjectThis 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 group	Active comparator	Other: Video + Expressive WritingVideo + 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Current college student enrolled at institution where research was taking place

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EVERYbody ProjectBrief behavioral intervention (4 hours across two meetings)	Behavioural	EVERYbody Project: Peer facilitator version
Video + Expressive WritingBrief video-based intervention (4 hours across two meetings)	Other	Video + Expressive Writing group

Primary outcome

Eating disorder symptoms
Time frame: Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)
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
Time frame: Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)
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
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)
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).

1 secondary outcome

Negative affect
Time frame: Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
Background: PubMed 29105805Ciao 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.
Background: PubMed 7866415Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
Background: PubMed 25285718Schaefer 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.
Background: PubMed 16649871Stice 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.
BackgroundBerscheid, E., Hatfield [Walster], E., & Bohrnstedt, G. (1973). The happy American body: A survey report. Psychology Today, 7, 119-131.
BackgroundWatson, 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
Background: PubMed 25959408Ciao 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.
Background: PubMed 27188688Kilpela 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 publication: PubMed 34014692Ciao 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna C Ciao, PhD principal investigator

Western Washington University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EVERYbody Project and Video + Expressive Writing in people with Body Image and Eating Disorder Symptom, run by Western Washington University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eating disorder symptoms (time frame: Assessed at baseline (Survey 1), post-intervention (Survey 2), and one-month follow-up (Survey 3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04517942, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.