NCT03219814

Brief Summary

The purpose of this study is to assess a cognitive dissonance-based eating disorder prevention intervention program on its ability to reduce attentional biases in body-dissatisfied women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 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

May 19, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

July 11, 2017

Last Update Submit

January 6, 2020

Conditions

Keywords

body-imageattentioncognitive dissonanceeating disorder prevention

Outcome Measures

Primary Outcomes (1)

  • Change from baseline attentional bias after completing the intervention/control condition, week 2

    using an EyeLink 1000 eye-tracking system gaze will be tracked for biases to view weight words and images

    change in attentional bias from baseline recorded at the end of the assigned intervention/control condition (week 2)

Secondary Outcomes (14)

  • Change from baseline body dissatisfaction after completing the intervention/control condition, week 2

    change in BSQ score from baseline measured at the end of the assigned intervention/control condition (week 2)

  • Change from baseline body dissatisfaction at the one-month follow up

    change in BSQ score from baseline measured in online follow-up survey administered one month after week 2 of the assigned intervention/control condition

  • Change from baseline body appreciation after completing the intervention/control condition, week 2

    change in Body Appreciation Scale score measured at the end of the assigned intervention/control condition (week 2)

  • Change from baseline body appreciation at the one-month follow up

    change in Body Appreciation Scale score measured in online follow-up survey administered one month after week 2 of the assigned intervention/control condition

  • Change from baseline thin-ideal internalization after completing the intervention/control condition, week 2

    change in SATAQ score measured at the end of the assigned intervention/control condition (week 2)

  • +9 more secondary outcomes

Study Arms (4)

Cognitive Dissonance Intervention

EXPERIMENTAL

Participants in the Cognitive Dissonance condition will complete tasks from Becker et al.'s (2005) 2-session adaptation of the Body Project. In the intervention groups, participants will be asked to consider the costs of pursuing the thin ideal in verbal, written, and behavioural exercises. Participants will be asked to assume the role as a body activist, and will be given several opportunities to vocalize opposition to the social forces that drive the thin ideal throughout the sessions. The first session will involve exercises and discussions about the thin ideal and the costs associated with pursuing it. They will be given a homework assignment to complete at home over the next week. In the following week's session the participants will engage in a role-play exercise, as well as continuing the discussion on the costs of pursuing the thin ideal.

Other: The Body Project

Mediapsychoeducation Intervention

ACTIVE COMPARATOR

Participants in the Mediapsychoeducation condition will complete two sessions of tasks as outlined for Becker et al.'s (2005) media psychoeducation group, which includes no cognitive dissonance tasks. The first session will have the participants discuss the thin ideal and the media's influence on it. They will then watch a 35-minute psychoeducational video on the influence that advertisements have on body image and perpetuating the thin ideal. They will be assigned homework to complete at home during the week between the sessions. The second session will include a discussion surrounding the attainability to the thin ideal, and this discussion will also be expanded to include all forms of media. Participants will then be asked to consider and discuss differences between media images and themselves, as well as whether achieving this "ideal" is realistic, and the costs in trying to achieve this thin ideal. They will then watch a 20-minute video on eating disorders.

Other: Mediapsychoeducation

Waitlist Control

NO INTERVENTION

The participants in the Waitlist condition will be given the Cognitive Dissonance intervention between 5 and 6 weeks after their second assessment-only session (the cognitive dissonance intervention will be offered and scheduled 1 week after their 1-month online follow-up questionnaire).

Body-Satisfied Assessment Only Condition

NO INTERVENTION

Body-satisfied women will be recruited to engage in the assessment portion of the study only (i.e. they will be given NO intervention but are serving as a control in terms of eye-tracking assessment). Body-satisfied women will be assessed to compare their attention to weight words with body-dissatisfied women's attention to weight words. This comparison will be done with an aim of replicating the findings of Tobin (2015), to ensure that for this particular sample, body-dissatisfied women exhibit stronger attentional biases for weight words than body-satisfied women. Attention to weight words in body-satisfied women will be assessed at two time points, one week apart, to ensure there are no spurious changes in attention in body satisfied women.

Interventions

The Body Project is a dissonance-based body-acceptance program designed to help high school girls and college-age women resist cultural pressures to conform to the appearance ideal standard of female beauty and reduce their pursuit of unrealistic bodies. The Body Project is supported by more research than any other body image program and has been found to reduce onset of eating disorders.

Cognitive Dissonance Intervention

Mediapsychoeducation is used to educate individuals on psychological issues through the use of various medias, in this study mediapsychoeducation is being used to educate individuals on eating disorders and the thin ideal.

Mediapsychoeducation Intervention

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale identified
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • body-dissatisfied for three conditions (cognitive dissonance, media psychoeducation, waitlist control)
  • body-satisfied for one condition (body-satisfied assessment only condition)
  • female-identified for all conditions

You may not qualify if:

  • male-identified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (10)

  • Becker, C. B., Smith, L. M., & Ciao, A. C. (2005). Reducing eating disorder risk factors in sorority members: A randomized trial. Behavior Therapy, 36, 245-253. doi:10.1016/S0005-7894(05)80073-5

    BACKGROUND
  • Cooper, P. J., Taylor, M. J., Cooper, Z., & Fairburn, C. G. (1987). The development and validation of the body shape questionnaire. International Journal of Eating Disorders, 6, 485-494. Retrieved from http://search.proquest.com/docview/617439169

    BACKGROUND
  • 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
  • Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.

    PMID: 25462882BACKGROUND
  • Van Strien, T., Frijters, J. E., Van Staveren, W. A., Defares, P. B., & Deurenberg, P. (1986). The predictive validity of the Dutch restrained eating scale. International Journal of Eating Disorders, 5(4), 747-755. doi:10.1002/1098-108X(198605)5:4<747::AID-EAT2260050413>3.0.CO;2-6

    BACKGROUND
  • Stice, E., Rohde, P., & Shaw, H. (2013). The Body Project: A dissonance-based eating disorder prevention intervention (Updated ed.). Facilitator guide.

    BACKGROUND
  • 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
  • Crandall CS. Prejudice against fat people: ideology and self-interest. J Pers Soc Psychol. 1994 May;66(5):882-94. doi: 10.1037//0022-3514.66.5.882.

    PMID: 8014833BACKGROUND
  • Lillis J, Luoma JB, Levin ME, Hayes SC. Measuring weight self-stigma: the weight self-stigma questionnaire. Obesity (Silver Spring). 2010 May;18(5):971-6. doi: 10.1038/oby.2009.353. Epub 2009 Oct 15.

    PMID: 19834462BACKGROUND
  • Tobin LN, Sears CR, von Ranson KM. Two eating disorder preventive interventions reduce attentional biases in body-dissatisfied university women: A cluster randomized controlled trial. J Consult Clin Psychol. 2022 Dec;90(12):911-924. doi: 10.1037/ccp0000768. Epub 2022 Nov 17.

Study Officials

  • Kristin von Ranson, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be unaware until completion of study as to which group they were assigned to (all participants who sign up are only given the information that they will be engaging in an eyetracking task and discussions about the media). The assessments consist of self-report questionnaires (which will be scores by a masked assessor), and eye-tracking, which is an objective measure of time spent gazing at various stimuli.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Psychology

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 18, 2017

Study Start

May 19, 2017

Primary Completion

March 28, 2018

Study Completion

April 30, 2018

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations