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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03219814
Other study ID # REB14-1451
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 19, 2017
Est. completion date April 30, 2018

Study information

Verified date January 2020
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Eating disorders are some of the most prevalent psychiatric disorders affecting women in Westernized cultures, and are associated with a range of medical complications; in severe cases, eating disorders can lead to death. Unfortunately, a large proportion of individuals with eating disorders do not receive treatment, and of those who do receive treatment, only approximately 40-50% of clients are symptom-free at the end of treatment. In addition to limited efficacy, existing treatments can be time-consuming and costly. From both public health and humanitarian perspectives it is best to prevent eating disorders prior to their emergence.

This study will use a randomized, controlled design to investigate the effects of a cognitive dissonance-based intervention on attentional biases for weight words in body-dissatisfied women. Cognitive dissonance is thought to occur when there is a discrepancy between one's beliefs or attitudes, and behaviour. The experience of dissonance is thought to create discomfort, and resultantly individuals change their beliefs to be in line with their behaviours. Thus, the core tenet of cognitive dissonance-based interventions is the concept of engaging participants in counter-attitudinal behaviours (e.g., speaking out against the thin ideal) to enact change through cognitive dissonance. This cognitive dissonance-based intervention (The Body Project) targets body dissatisfaction, thin-ideal internalization, and eating disorder symptoms.

Almost all research on the Body Project has assessed its efficacy via self-report, however, this study will use an eye-tracker to measure the gaze. Attentional biases are less susceptible to self-reporting biases than traditional pencil-and-paper questionnaires and so are a more reliable measure of cognitive processing The participants in this study will be placed into one of three different conditions: cognitive dissonance (CD), media psychoeducation (MP), or waitlist control (WL), and a similar number of women will be allocated to the body-satisfied (BS) condition. Both the CD and MP intervention groups will consist of two approximately 2-hour sessions scheduled one week apart, as well as a 30-minute online follow-up questionnaire 1 month after the second intervention/assessment session. Individuals allocated to WL will begin to receive the intervention approximately 5 weeks after the CD and MP groups (after their 1 month follow-up survey). The BS group will consist of two approximately 35- to 40-minute assessment-only sessions scheduled one week apart.

All groups of participants will full out several self-report questionnaire as well as participate in a brief eye-tracking assessment both before and after their allocated intervention group (the BS condition and waitlist control will only complete the questionnaires and eye tracking assessment). Participants will sign up for a group time slot, and the group time slots will be randomly assigned to be given either the CD, and MP, or the WL condition.

Participants will be recruited through the University of Calgary Department of Psychology Research Participation System (RPS) as well as campus community participants recruited through campus advertisements. Potential participants will be pre-screened for the presence of body dissatisfaction (or body satisfaction for the BS assessment only group).


Recruitment information / eligibility

Status Completed
Enrollment 228
Est. completion date April 30, 2018
Est. primary completion date March 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- male-identified

Study Design


Related Conditions & MeSH terms


Intervention

Other:
The Body Project
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.
Mediapsychoeducation
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.

Locations

Country Name City State
Canada University of Calgary Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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

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

Crandall CS. Prejudice against fat people: ideology and self-interest. J Pers Soc Psychol. 1994 May;66(5):882-94. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from baseline body dissatisfaction after completing the intervention/control condition, week 2 Level of body dissatisfaction will be measured using the Body Shape Questionnaire (BSQ; Cooper, Taylor, Cooper, & Fairburn, 1987). change in BSQ score from baseline measured at the end of the assigned intervention/control condition (week 2)
Secondary Change from baseline body dissatisfaction at the one-month follow up Level of body dissatisfaction will be measured using the Body Shape Questionnaire (BSQ; Cooper, Taylor, Cooper, & Fairburn, 1987). change in BSQ score from baseline measured in online follow-up survey administered one month after week 2 of the assigned intervention/control condition
Secondary Change from baseline body appreciation after completing the intervention/control condition, week 2 body appreciation will be assessed using the the Body Appreciation Scale (Tylka & Wood-Barcalow, 2015). change in Body Appreciation Scale score measured at the end of the assigned intervention/control condition (week 2)
Secondary Change from baseline body appreciation at the one-month follow up body appreciation will be assessed using the the Body Appreciation Scale (Tylka & Wood-Barcalow, 2015). change in Body Appreciation Scale score measured in online follow-up survey administered one month after week 2 of the assigned intervention/control condition
Secondary Change from baseline thin-ideal internalization after completing the intervention/control condition, week 2 thin-ideal internalization will be assessed using the internalization subscale of the Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ; Schaefer et al., 2015) change in SATAQ score measured at the end of the assigned intervention/control condition (week 2)
Secondary Change from baseline thin-ideal internalization at the one-month follow up thin-ideal internalization will be assessed using the internalization subscale of the Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ; Schaefer et al., 2015) Change in SATAQ score measured in online follow-up survey administered one month after week 2 of the assigned intervention/control condition
Secondary Change from baseline eating pathology after completing the intervention/control condition, week 2 eating pathology will be assessed using the Eating Disorder Examination Questionnaire (EDE-Q 6.0; Fairburn & Beglin, 1994) change in EDE-Q score measured at the end of the assigned intervention/control condition (week 2)
Secondary Change from baseline eating pathology at the one-month follow up eating pathology will be assessed using the Eating Disorder Examination Questionnaire (EDE-Q 6.0; Fairburn & Beglin, 1994) change in EDE-Q score measured in online follow-up survey administered one month after week 2 of the assigned intervention/control condition
Secondary Change from baseline explicit weight stigma after completing the intervention/control condition, week 2 Explicit weight stigma will be assessed using the Anti-Fat Attitudes Questionnaire (Crandall, 1994) change in Anti-Fat Attitudes Questionnaire score measured at the end of the assigned intervention/control condition (week 2)
Secondary Change from baseline explicit weight stigma at the one-month follow up Explicit weight stigma will be assessed using the Anti-Fat Attitudes Questionnaire (Crandall, 1994) Change in Anti-Fat Attitudes Questionnaire score measured in online follow-up survey administered one month after week 2 of the assigned intervention/control condition
Secondary Change from baseline weight self-stigma after completing the intervention/control condition, week 2 Weight self-stigma will be assessed using the Weight Self-Stigma Questionnaire (Lillis et al., 2010) change in Weight Self-Stigma Questionnaire score measured at the end of the assigned intervention/control condition (week 2)
Secondary Change from baseline weight self-stigma at the one-month follow up Weight self-stigma will be assessed using the Weight Self-Stigma Questionnaire (Lillis et al., 2010) change in Weight Self-Stigma Questionnaire score measured in online follow-up survey administered one month after week 2 of the assigned intervention/control condition
Secondary Change from baseline state body dissatisfaction after completing the intervention/control condition, week 2 State body dissatisfaction will be assessed using a Visual Analogue Scale that asks participants to rate their current level of body satisfaction/dissatisfaction on a scale from 0 (extremely satisfied with your body) to 100 (extremely dissatisfied with your body) change in Body Dissatisfaction Visual Analogue Scale score measured at the end of the assigned intervention/control condition (week 2)
Secondary Change from baseline state body dissatisfaction at the one-month follow up State body dissatisfaction will be assessed using a Visual Analogue Scale that asks participants to rate their current level of body satisfaction/dissatisfaction on a scale from 0 (extremely satisfied with your body) to 100 (extremely dissatisfied with your body) change in Body Dissatisfaction Visual Analogue Scale score measured in online follow-up survey administered one month after week 2 of the assigned intervention/control condition