NCT04529746

Brief Summary

A pilot randomized-controlled trial explored the feasibility, acceptability, and efficacy of an inclusive dissonance-based body image intervention called the EVERYbody Project. The professionally delivered EVERYbody Project was evaluated in a universal college student population compared to a waitlist control group through one-month follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

August 15, 2020

Last Update Submit

August 5, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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).

    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

    Assessed change from baseline (Survey 1) through post-intervention (Survey 2; immediately after intervention) and one-month follow-up (Survey 3; one month after intervention). Waitlist was assessed at parallel time points.

Other Outcomes (2)

  • Open-ended interviews

    Students are invited to participate after completing their follow-up survey (Survey 3) or one month after their participation in the EVERYbody Project.

  • Program satisfaction and application: questions included four Likert scale

    Assessed at post-intervention (Survey 2; immediately following the intervention) and one-month follow-up (Survey 3; four weeks post intervention).

Study Arms (2)

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.

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.

Interventions

Brief behavioral intervention (4 hours across two meetings)

EVERYbody Project: Professional facilitator version

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Washington University

Bellingham, Washington, 98225, United States

Location

Related Publications (9)

  • 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.

    PMID: 29105805BACKGROUND
  • Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.

    PMID: 7866415BACKGROUND
  • 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.

    PMID: 25285718BACKGROUND
  • 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.

    PMID: 16649871BACKGROUND
  • Berscheid, E., Hatfield [Walster], E., & Bohrnstedt, G. (1973). The happy American body: A survey report. Psychology Today, 7, 119-131.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 25959408BACKGROUND
  • 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.

    PMID: 27188688BACKGROUND
  • 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.

Study Officials

  • Anna C Ciao, PhD

    Western Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Participants were randomized on a 1-1 basis to receive either the EVERYbody Project or be on the waitlist control list (assessment-only control).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

August 15, 2020

First Posted

August 28, 2020

Study Start

October 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 12, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Since the trial is complete, data are available immediately upon request.
More information

Locations