- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04118972
In the Mirror: Functional Appreciated Bodies (IM FAB) (IMFAB)
In the Mirror: Functional Appreciated Bodies (IM FAB): Piloting an Easily Disseminable Primary Prevention Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Specific Aim 1. First, the project aims to test a gratitude-based body functionality primary prevention program, In the Mirror: Functional Appreciated Bodies (IM FAB), that incorporates mirror exposure with a greater intervention "dose" than that piloted by Brooks and Walker. The increased dose should allow for greater ability for participants to consolidate exposure-based learning. Specifically, more time instructed to appreciate the body's functionality allows for more occasions to redirect critical appearance-oriented cognitions to appreciative, function-based cognitions.
Specific Aim 2. Second, the project aims to pilot test a relatively minimalistic intervention that would be easily translated to app-based delivery format, to help overcome the most-cited barriers to prevention program participation noted by undergraduate students in universal prevention research. Specifically, undergraduate participants who were assigned to a prevention program but did not enroll questioned a need for counseling/therapy, reported preferring to deal with issues on their own, and cited a lack of time as reasons they did not enroll.
Specific Aim 3. Third, the project aims to test this specific functionality mirror exposure approach largely on its own, rather than as part of a multicomponent treatment program, so that its unique contribution in preventing body image dissatisfaction, and ultimately eating disorders, can be assessed. A main goal in prevention and treatment development remains to continuously test components of body-image interventions separately for efficacy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: D. Catherine Walker, PhD
- Phone Number: 15185263778
- Email: walkerc@union.edu
Study Contact Backup
- Name: Drew A. Anderson, PhD
- Phone Number: 1-518-442-4835
- Email: drewa@albany.edu
Study Locations
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New York
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Albany, New York, United States, 12222
- University at Albany, State University of New York
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Schenectady, New York, United States, 12308
- Union College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergraduate female aged 18-23 years.
Exclusion Criteria:
- Self-definition as having an active eating disorder
- Participation in the Body Project
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Functionality Mirror Exposure & Journal
A text-based functionality gratitude "journaling" prompt three times weekly paired with three weeks of weekly functionality-based guided mirror exposure sessions in the lab (the IM FAB program)
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Participants in the active interventions have three weekly mirror exposure sessions that are either guided with specific instructions as to where to look and how (only in functionality condition)
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Active Comparator: Pure Mirror Exposure & Gratitude Journal
Thrice weekly generic (non body-focused) gratitude text prompts and pure mirror exposure in the lab.
Participants are not given instructions on how to examine body parts, only instructed to examine the same specific body parts as the Functionality group to control specifically for impacts of the body functionality focus.
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Participants in the active interventions have three weekly mirror exposure sessions that are either guided with specific instructions as to where to look and how (only in functionality condition)
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No Intervention: Assessment only control
Assessments at Week 1, Week 3, and 1- and 4-month follow-ups, identical to those received by participants in the active condition
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Multidimensional Body Self-Relations Questionnaire scores (MBSRQ; Cash, 2000)
Time Frame: Change from Baseline MBSRQ scores to 20 weeks
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69-item questionnaire with Likert-type scale ranging from 1-5.
Trait body image satisfaction with subscales assessing: Appearance Evaluation, Appearance Orientation, Fitness Evaluation, Fitness Orientation, Health Evaluation, Health Orientation, Illness Orientation, Body Areas Satisfaction, Overweight Preoccupation, and Self-Classified Weight; Scores are averaged for each subscale with a range of 1-5.
Fitness, Health, and Appearance Evaluation scores that are higher reflect more positive attitudes about one's fitness, health, and appearance, respectively.
Higher appearance, fitness, health, and illness orientation, and overweight preoccupation scores reflect greater investment in appearance, health, concerns about becoming ill, fitness, and preoccupation with weight.
Higher Body Areas Satisfaction reflects more positive body image.
Higher self-classified weight reflects self-reported higher weight categorization (e.g., overweight or obese)
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Change from Baseline MBSRQ scores to 20 weeks
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Change in Eating Disorder Diagnostic Scale scores (EDDS; Stice, Fisher & Martinez, 2004)
Time Frame: Change from baseline EDDS scores to 20 weeks
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Eating disorder diagnostic scale for the DSM-5.
This is a diagnostic measure, so participants respond to questions regarding binge eating, purging and other compensatory behaviors, weight and shape concern, weight loss, height, weight, and fear of weight gain to determine whether they meet diagnostic criteria for anorexia nervosa, bulimia nervosa, binge eating disorder, atypical anorexia nervosa, low frequency bulimia nervosa, low frequency binge eating disorder, purging disorder, or night eating syndrome.
See http://www.ori.org/files/Static%20Page%20Files/EDDS_5.pdf for specific scoring instructions.
Higher scale scores represent greater eating disorder pathology.
As a diagnostic tool, respondents need to meet DSM-5 criteria for an eating disorder based on specific item responses, and would be scored as indicating a specific eating disorder diagnosis based on those specific item responses.
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Change from baseline EDDS scores to 20 weeks
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Change in Body Checking Questionnaire scores (BCQ; Reas, Whisenhunt, Netemeyer, & Williamson, 2002)
Time Frame: Change from baseline BCQ scores to 20 weeks
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Body checking questionnaire.
23-item 5-point Likert-type scale ranging from 1-5.
Three subscales assess: Overall appearance checking, specific body part checking, and idiosyncratic checking.
Items are summed for for each subscale and for a total score.
Total score ranges from 23-115.
Higher scores reflect greater frequency of body checking behaviors.
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Change from baseline BCQ scores to 20 weeks
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Change in Body Image Avoidance Questionnaire scores (BIAQ; Rosen, Srebnik, Saltzberg, & Wendt, 1991)
Time Frame: Change from baseline BIAQ scores to 20 weeks
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Body image avoidance questionnaire.
Measures avoidance of one's body across a range of evaluative contexts.
19 6-point Likert-type scale ranging from 0-5, with three items reverse scored (12, 13, and 19).
Items are summed, with a possible range from 0-95.
Higher scores reflect greater body image avoidance and are typically associated with greater psychopathology.
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Change from baseline BIAQ scores to 20 weeks
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Change in Body Appreciation Scale-2 scores (BAS-2; Tylka, & Wood-Barcalow, 2015)
Time Frame: Change from baseline BAS-2 scores to 20 weeks
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Body appreciation measure.
10-item 5-point Likert-type scale.
Items reflect accepting and holding positive views about one's body.
Items are averaged with higher scores reflecting great body appreciation.
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Change from baseline BAS-2 scores to 20 weeks
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Change in Functional Appreciation Scale scores (FAS; Alleva, Tylka, & Van Deist, 2017)
Time Frame: Change from baseline FAS scores to 20 weeks
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Scale assesses appreciation of the body's functions.
7-item 5-point Likert-type scale with items ranging from 1-5.
Items are averaged with greater scores reflecting greater appreciation of the functions and capabilities of one's body.
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Change from baseline FAS scores to 20 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability Metric for User Experience (UMUX; Finstad, 2010)
Time Frame: Post-Intervention (Week 3)
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4 7-point Likert-type items ranging from 0-6, after recoding, which assesses the usability and ease of the IMFAB protocol.
The items are summed for a possible range of 0-24 points, with greater scores representing greater usability of the technology or protocol in question.
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Post-Intervention (Week 3)
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Feasibility of mobile application scale, derived from UMUX format
Time Frame: Post-Intervention (Week 3)
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5 7-point Likert-scale items and one open-ended item assessing feasibility of the IMFAB protocol delivery via mobile application.
Questions range from 0-6 after recoding and are summed.
Greater scores reflect higher ratings of feasibility of adopting IMFAB in mobile application format.
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Post-Intervention (Week 3)
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Engagement with IMFAB protocol scale, derived from UMUX format.
Time Frame: Post-Intervention (Week 3)
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9 7-point Likert-type scale items & 3 open-ended questions assessing participant engagement with IM FAB protocol.
Likert-type items range from 0-6 and are summed after reverse coding.
Greater scores reflect more positive attitudes toward the intervention design (e.g., mirror exposure exercises and gratitude text prompts).
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Post-Intervention (Week 3)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gratitude Text Responses - Qualitative
Time Frame: Days 2, 4, 6, 8, 10, and 12
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6 Gratitude text responses during the experimental group intervention period will be assessed with qualitative analyses to assess relationship between responses and primary outcome
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Days 2, 4, 6, 8, 10, and 12
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: D. Catherine Walker, Union College
Publications and helpful links
General Publications
- 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.
- Cash TF, Fleming EC, Alindogan J, Steadman L, Whitehead A. Beyond body image as a trait: the development and validation of the Body Image States Scale. Eat Disord. 2002 Summer;10(2):103-13. doi: 10.1080/10640260290081678.
- Stice E, Fisher M, Martinez E. Eating disorder diagnostic scale: additional evidence of reliability and validity. Psychol Assess. 2004 Mar;16(1):60-71. doi: 10.1037/1040-3590.16.1.60.
- Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.
- Cash TF, Green GK. Body weight and body image among college women: perception, cognition, and affect. J Pers Assess. 1986 Summer;50(2):290-301. doi: 10.1207/s15327752jpa5002_15.
- Reas DL, Whisenhunt BL, Netemeyer R, Williamson DA. Development of the body checking questionnaire: a self-report measure of body checking behaviors. Int J Eat Disord. 2002 Apr;31(3):324-33. doi: 10.1002/eat.10012.
- Stice E, Telch CF, Rizvi SL. Development and validation of the Eating Disorder Diagnostic Scale: a brief self-report measure of anorexia, bulimia, and binge-eating disorder. Psychol Assess. 2000 Jun;12(2):123-31. doi: 10.1037//1040-3590.12.2.123.
- Froh JJ, Fan J, Emmons RA, Bono G, Huebner ES, Watkins P. Measuring gratitude in youth: assessing the psychometric properties of adult gratitude scales in children and adolescents. Psychol Assess. 2011 Jun;23(2):311-24. doi: 10.1037/a0021590.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UnionC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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