NCT05030532

Brief 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. Expert peer leaders were college students with lived and/or academic expertise who were screened for facilitation readiness through a two-day training.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

August 5, 2021

Last Update Submit

September 9, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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).

    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).

    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).

    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.

    Change from baseline through post-intervention (1-2 weeks) and follow-up (3 months)

Other Outcomes (1)

  • Program satisfaction and application

    Assessed at post-intervention (1-2 weeks after baseline) and follow-up (3 months)

Study Arms (2)

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.

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.

Other: Video + Expressive Writing

Interventions

Brief behavioral group intervention (4 hours across two meetings)

EVERYbody Project: Expert facilitator version

Brief video-based group 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 (10)

  • 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.

    PMID: 34014692BACKGROUND
  • 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
  • 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.

    PMID: 28122128BACKGROUND
  • Becker 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.

    PMID: 28726480BACKGROUND
  • 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

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

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 20 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 5, 2021

First Posted

September 1, 2021

Study Start

October 1, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

September 16, 2021

Record last verified: 2021-09

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