Body ImageNCT05030532
Expert Peer Facilitation of the 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.
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. 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
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 30 Jun 2020
- 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
About this study
Official title: Expert Peer Facilitation of the EVERYbody Project: A Randomized-controlled Evaluation of a Diversity-focused, Dissonance-based, Universal Body Image Program for College Students
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.
Read the detailed 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.
- 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 group intervention (4 hours across two meetings)
Video + Expressive WritingOther
Brief video-based group intervention (4 hours across two meetings)
| Study group | Role | What they receive |
|---|---|---|
| EVERYbody Project: Expert facilitator version | Experimental | This gender inclusive, dissonance-based body image program was created from focus group feedback. Based on the Body Project, the program retains key dissonance activities while expanding the inclusivity focus (e.g., expanding the gender focus, exploring diversity within appearance ideals, critically discussing the impact of limited diversity representation in cultural appearance norms).
Around 10% of content from the previous trial was modified to form the current intervention. Changes focused on enhancing diversity-focused content. College students with body image content interest completed two days (16 hours) of training on the program manual, group management, and conducting inclusive conversations. Post training, students self-assessed their facilitation readiness and were evaluated by two trainers on facilitation expertise. Peer leaders with sufficient expertise were invited to facilitate EVERYbody Project groups. 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, and (2) The Mask You Live In. 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 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).
Measured: Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
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).
Measured: Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
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).
Measured: Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
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.
Measured: Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Oct 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: In-person intervention activities halted in March 2020 due to COVID-19; follow-up data collection of active participants completed online in June 2020.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 20 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Ciao, Western Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030532
- Sponsor's protocol ID
- 17-004_3
- Status last verified
- Sep 2021
- First submitted
- 5 Aug 2021
- Last updated
- 16 Sep 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, 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 34014692Ciao 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 29105805Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
PubMed 7866415Schaefer 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 25285718Stice 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 16649871Berscheid, 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
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.
PubMed 28122128Becker 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.
PubMed 28726480Kilpela 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Peer Facilitation of the EVERYbody Project: A Randomized-controlled Evaluation of a Diversity-focused, Dissonance-based, Universal Body Image Program for College Students
- ClinicalTrials.gov ID
- NCT05030532
- Acronym / sponsor ID
- 17-004_3
- Conditions
- Body Image, Eating Disorder Symptom
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In-person intervention activities halted in March 2020 due to COVID-19; follow-up data collection of active participants completed online in June 2020.
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Western Washington UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 1 Sep 2021 (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.
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.
Detailed 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.
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 20 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: Expert facilitator version | Experimental | Behavioral: EVERYbody ProjectThis gender inclusive, dissonance-based body image program was created from focus group feedback. Based on the Body Project, the program retains key dissonance activities while expanding the inclusivity focus (e.g., expanding the gender focus, exploring diversity within appearance ideals, critically discussing the impact of limited diversity representation in cultural appearance norms). Around 10% of content from the previous trial was modified to form the current intervention. Changes focused on enhancing diversity-focused content. College students with body image content interest completed two days (16 hours) of training on the program manual, group management, and conducting inclusive conversations. Post training, students self-assessed their facilitation readiness and were evaluated by two trainers on facilitation expertise. Peer leaders with sufficient expertise were invited to facilitate EVERYbody Project groups. |
| 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, and (2) The Mask You Live In. 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 group intervention (4 hours across two meetings) | Behavioural | EVERYbody Project: Expert facilitator version |
| Video + Expressive WritingBrief video-based group intervention (4 hours across two meetings) | Other | Video + Expressive Writing group |
Primary outcome
Eating disorder symptoms
Time frame: Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
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).
Body Dissatisfaction
Time frame: Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
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).
Internalized cultural appearance norms
Time frame: Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
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).
Negative affect
Time frame: Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)
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.
Results and safety
The study was stopped early (reason given: In-person intervention activities halted in March 2020 due to COVID-19; follow-up data collection of active participants completed online in June 2020.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: 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.
- 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 28122128Kliem 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.
- Background: PubMed 28726480Becker 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.
- 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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: stopped early, as of the sponsor's last update on 16 Sep 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 was stopped early (reason given: In-person intervention activities halted in March 2020 due to COVID-19; follow-up data collection of active participants completed online in June 2020.). Results are not available in the source record.
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: Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)). The study lists 4 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 NCT05030532, which also lists 10 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 16 Sep 2021.