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In the Mirror: Functional Appreciated Bodies (IM FAB) (IMFAB)

Primary Purpose

Eating Disorder Symptom, Body Image Disturbance

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mirror exposure and text prompt responses
Sponsored by
Union College, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorder Symptom

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Undergraduate female aged 18-23 years.

Exclusion Criteria:

  • Self-definition as having an active eating disorder
  • Participation in the Body Project

Sites / Locations

  • University at Albany, State University of New YorkRecruiting
  • Union CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Functionality Mirror Exposure & Journal

Pure Mirror Exposure & Gratitude Journal

Assessment only control

Arm Description

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)

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.

Assessments at Week 1, Week 3, and 1- and 4-month follow-ups, identical to those received by participants in the active condition

Outcomes

Primary Outcome Measures

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 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 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 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 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 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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
October 9, 2018
Last Updated
September 27, 2021
Sponsor
Union College, New York
Collaborators
University at Albany, National Eating Disorder Association Feeding Hope Fund
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1. Study Identification

Unique Protocol Identification Number
NCT04118972
Brief Title
In the Mirror: Functional Appreciated Bodies (IM FAB)
Acronym
IMFAB
Official Title
In the Mirror: Functional Appreciated Bodies (IM FAB): Piloting an Easily Disseminable Primary Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Union College, New York
Collaborators
University at Albany, National Eating Disorder Association Feeding Hope Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder Symptom, Body Image Disturbance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to one of two active conditions or a control group.
Masking
Investigator
Masking Description
Participants are blinded to their study conditions. Investigators are aware of the study conditions but are not present for or delivering the active portions of the intervention directly. Participants in either active condition receive digitally delivered interventions.
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functionality Mirror Exposure & Journal
Arm Type
Experimental
Arm Description
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)
Arm Title
Pure Mirror Exposure & Gratitude Journal
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Assessment only control
Arm Type
No Intervention
Arm Description
Assessments at Week 1, Week 3, and 1- and 4-month follow-ups, identical to those received by participants in the active condition
Intervention Type
Behavioral
Intervention Name(s)
Mirror exposure and text prompt responses
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in Multidimensional Body Self-Relations Questionnaire scores (MBSRQ; Cash, 2000)
Description
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)
Time Frame
Change from Baseline MBSRQ scores to 20 weeks
Title
Change in Eating Disorder Diagnostic Scale scores (EDDS; Stice, Fisher & Martinez, 2004)
Description
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.
Time Frame
Change from baseline EDDS scores to 20 weeks
Title
Change in Body Checking Questionnaire scores (BCQ; Reas, Whisenhunt, Netemeyer, & Williamson, 2002)
Description
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.
Time Frame
Change from baseline BCQ scores to 20 weeks
Title
Change in Body Image Avoidance Questionnaire scores (BIAQ; Rosen, Srebnik, Saltzberg, & Wendt, 1991)
Description
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.
Time Frame
Change from baseline BIAQ scores to 20 weeks
Title
Change in Body Appreciation Scale-2 scores (BAS-2; Tylka, & Wood-Barcalow, 2015)
Description
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.
Time Frame
Change from baseline BAS-2 scores to 20 weeks
Title
Change in Functional Appreciation Scale scores (FAS; Alleva, Tylka, & Van Deist, 2017)
Description
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.
Time Frame
Change from baseline FAS scores to 20 weeks
Secondary Outcome Measure Information:
Title
Usability Metric for User Experience (UMUX; Finstad, 2010)
Description
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.
Time Frame
Post-Intervention (Week 3)
Title
Feasibility of mobile application scale, derived from UMUX format
Description
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.
Time Frame
Post-Intervention (Week 3)
Title
Engagement with IMFAB protocol scale, derived from UMUX format.
Description
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).
Time Frame
Post-Intervention (Week 3)
Other Pre-specified Outcome Measures:
Title
Gratitude Text Responses - Qualitative
Description
6 Gratitude text responses during the experimental group intervention period will be assessed with qualitative analyses to assess relationship between responses and primary outcome
Time Frame
Days 2, 4, 6, 8, 10, and 12

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants must self-identify as female.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Undergraduate female aged 18-23 years. Exclusion Criteria: Self-definition as having an active eating disorder Participation in the Body Project
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
D. Catherine Walker, PhD
Phone
15185263778
Email
walkerc@union.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Drew A. Anderson, PhD
Phone
1-518-442-4835
Email
drewa@albany.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Catherine Walker
Organizational Affiliation
Union College
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Albany, State University of New York
City
Albany
State/Province
New York
ZIP/Postal Code
12222
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drew A Anderson, PhD
Phone
518-442-4835
Email
daanderson@albany.edu
Facility Name
Union College
City
Schenectady
State/Province
New York
ZIP/Postal Code
12308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D. Catherine C Walker, PhD
Phone
518-388-6538
Email
walkerc@union.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared 6 months after initial publication of data analyses from the current study. Researchers will need to submit a proposal for access to the dataset and demonstrate IRB approval for secondary analysis of the data, if using the dataset for research purposes.
IPD Sharing Time Frame
6 months after initial publication of data analyses from the current study.
IPD Sharing Access Criteria
Researchers will need to submit a proposal for access to the dataset and demonstrate IRB approval if using the dataset for research purposes.
Citations:
PubMed Identifier
16864251
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.
Results Reference
background
PubMed Identifier
3761129
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.
Results Reference
background
PubMed Identifier
25462882
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.
Results Reference
background
PubMed Identifier
11920995
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.
Results Reference
background
PubMed Identifier
28822275
Citation
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.
Results Reference
background
PubMed Identifier
10887758
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.
Results Reference
background
PubMed Identifier
15023093
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.
Results Reference
background
PubMed Identifier
21443367
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.
Results Reference
background

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In the Mirror: Functional Appreciated Bodies (IM FAB)

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