Body ImageNCT04529746
Pilot Evaluation of the EVERYbody Project
A study testing EVERYbody Project in people with Body Image and Eating Disorder Symptom, run by Western Washington University at 1 site in United States.
Trial 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… 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 1 Sep 2017
- 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: A Pilot Evaluation of the EVERYbody Project: Professionally-delivered Inclusive Eating Disorder Risk Factor Reduction for College Students
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.
Read the 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.
- Conditions
- Body Image, Eating Disorder Symptom
- Being tested
- EVERYbody Project
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)
| Study group | Role | What they receive |
|---|---|---|
| EVERYbody Project: Professional facilitator version | Experimental | 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. Receives: Behavioral: EVERYbody Project |
| Waitlist control group | No intervention | 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. |
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 with a 0-6 range; higher scores equal greater eating disorder symptoms).
Measured: 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.
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).
Measured: 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.
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).
Measured: 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 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 with 1-5 range; higher scores equal greater negative affect.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Oct 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
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
- 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)
- Enrolment
- 98 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
- Investigators
- Anna C Ciao, PhD, Principal investigator, Western Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529746
- Sponsor's protocol ID
- 17-004_1
- 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 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
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 25959408Kilpela 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 27188688Ciao 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
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
- A Pilot Evaluation of the EVERYbody Project: Professionally-delivered Inclusive Eating Disorder Risk Factor Reduction for College Students
- ClinicalTrials.gov ID
- NCT04529746
- Acronym / sponsor ID
- 17-004_1
- Conditions
- Body Image, Eating Disorder Symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Western Washington UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 28 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| EVERYbody Project: Professional facilitator version | Experimental | Behavioral: EVERYbody ProjectThe 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. |
| Waitlist control group | No intervention | –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. |
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: Professional facilitator version |
Primary outcome
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.
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
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.
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
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.
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).
1 secondary outcome
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.
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 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 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.). 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 NCT04529746, 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.