NCT04517942

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 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).

    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).

    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).

    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

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

Other Outcomes (1)

  • Program satisfaction and application

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

Study Arms (2)

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.).

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.

Other: Video + Expressive Writing

Interventions

Brief behavioral intervention (4 hours across two meetings)

EVERYbody Project: Peer facilitator version

Brief video-based intervention (4 hours across two meetings)

Video + Expressive Writing group

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.

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

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: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

August 15, 2020

First Posted

August 19, 2020

Study Start

October 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

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