In the Mirror: Functional Appreciated Bodies (IM FAB)

Eating Disorder Symptom Clinical Trial

— IMFAB  

Official title:

In the Mirror: Functional Appreciated Bodies (IM FAB): Piloting an Easily Disseminable Primary Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118972
• Other study ID #: UnionC
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2023
• Source: Union College, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current project aims to examine the concept of promoting attention toward body functionality and gratitude using a weekly functionality-based mirror exposure and body functionality gratitude "journaling" text prompts three days a week for three weeks to examine whether this helps foster positive body image and decrease eating disorder symptoms in a sample of undergraduate females, a population at particularly high risk of body image dissatisfaction and consequent eating disorder development.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: December 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergraduate female aged 18-23 years.

Exclusion Criteria:

• Self-definition as having an active eating disorder

• Participation in the Body Project

Related Conditions & MeSH terms

• Body Image Disturbance
• Eating Disorder Symptom
• Feeding and Eating Disorders

Intervention

Behavioral:
• Mirror exposure and text prompt responses
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)

Locations

Country	Name	City	State
United States	University at Albany, State University of New York	Albany	New York
United States	Union College	Schenectady	New York

Sponsors (2)

Lead Sponsor	Collaborator
Union College, New York	University at Albany

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gratitude Text Responses - Qualitative	6 Gratitude text responses during the experimental group intervention period will be assessed with qualitative analyses to assess relationship between responses and primary outcome	Days 2, 4, 6, 8, 10, and 12
Primary	Change in Multidimensional Body Self-Relations Questionnaire scores (MBSRQ; Cash, 2000)	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)	Change from Baseline MBSRQ scores to 20 weeks
Primary	Change in Eating Disorder Diagnostic Scale scores (EDDS; Stice, Fisher & Martinez, 2004)	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.	Change from baseline EDDS scores to 20 weeks
Primary	Change in Body Checking Questionnaire scores (BCQ; Reas, Whisenhunt, Netemeyer, & Williamson, 2002)	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.	Change from baseline BCQ scores to 20 weeks
Primary	Change in Body Image Avoidance Questionnaire scores (BIAQ; Rosen, Srebnik, Saltzberg, & Wendt, 1991)	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.	Change from baseline BIAQ scores to 20 weeks
Primary	Change in Body Appreciation Scale-2 scores (BAS-2; Tylka, & Wood-Barcalow, 2015)	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.	Change from baseline BAS-2 scores to 20 weeks
Primary	Change in Functional Appreciation Scale scores (FAS; Alleva, Tylka, & Van Deist, 2017)	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.	Change from baseline FAS scores to 20 weeks
Secondary	Usability Metric for User Experience (UMUX; Finstad, 2010)	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.	Post-Intervention (Week 3)
Secondary	Feasibility of mobile application scale, derived from UMUX format	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.	Post-Intervention (Week 3)
Secondary	Engagement with IMFAB protocol scale, derived from UMUX format.	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).	Post-Intervention (Week 3)