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

Sponsor
Union College, New York (Other)
Overall Status
Recruiting
CT.gov ID
NCT04118972
Collaborator
University at Albany (Other), National Eating Disorder Association Feeding Hope Fund (Other)
225
2
3
44
112.5
2.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mirror exposure and text prompt responses
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomly assigned to one of two active conditions or a control group.Participants are randomly assigned to one of two active conditions or a control group.
Masking:
Single (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.
Primary Purpose:
Prevention
Official Title:
In the Mirror: Functional Appreciated Bodies (IM FAB): Piloting an Easily Disseminable Primary Prevention Program
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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)

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)

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.

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)

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

Outcome Measures

Primary Outcome Measures

  1. Change in Multidimensional Body Self-Relations Questionnaire scores (MBSRQ; Cash, 2000) [Change from Baseline MBSRQ scores to 20 weeks]

    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)

  2. Change in Eating Disorder Diagnostic Scale scores (EDDS; Stice, Fisher & Martinez, 2004) [Change from baseline EDDS scores to 20 weeks]

    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.

  3. Change in Body Checking Questionnaire scores (BCQ; Reas, Whisenhunt, Netemeyer, & Williamson, 2002) [Change from baseline BCQ scores to 20 weeks]

    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.

  4. Change in Body Image Avoidance Questionnaire scores (BIAQ; Rosen, Srebnik, Saltzberg, & Wendt, 1991) [Change from baseline BIAQ scores to 20 weeks]

    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.

  5. Change in Body Appreciation Scale-2 scores (BAS-2; Tylka, & Wood-Barcalow, 2015) [Change from baseline BAS-2 scores to 20 weeks]

    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.

  6. Change in Functional Appreciation Scale scores (FAS; Alleva, Tylka, & Van Deist, 2017) [Change from baseline FAS scores to 20 weeks]

    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

  1. Usability Metric for User Experience (UMUX; Finstad, 2010) [Post-Intervention (Week 3)]

    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.

  2. Feasibility of mobile application scale, derived from UMUX format [Post-Intervention (Week 3)]

    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.

  3. Engagement with IMFAB protocol scale, derived from UMUX format. [Post-Intervention (Week 3)]

    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).

Other Outcome Measures

  1. Gratitude Text Responses - Qualitative [Days 2, 4, 6, 8, 10, and 12]

    6 Gratitude text responses during the experimental group intervention period will be assessed with qualitative analyses to assess relationship between responses and primary outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Undergraduate female aged 18-23 years.
Exclusion Criteria:
  • Self-definition as having an active eating disorder

  • Participation in the Body Project

Contacts and Locations

Locations

Site City State Country Postal Code
1 University at Albany, State University of New York Albany New York United States 12222
2 Union College Schenectady New York United States 12308

Sponsors and Collaborators

  • Union College, New York
  • University at Albany
  • National Eating Disorder Association Feeding Hope Fund

Investigators

  • Principal Investigator: D. Catherine Walker, Union College

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Catherine Walker, Visiting Assistant Professor, Union College, New York
ClinicalTrials.gov Identifier:
NCT04118972
Other Study ID Numbers:
  • UnionC
First Posted:
Oct 8, 2019
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2021