NCT04118972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
12 months until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

3.3 years

First QC Date

October 9, 2018

Last Update Submit

December 5, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Usability Metric for User Experience (UMUX; Finstad, 2010)

    Post-Intervention (Week 3)

  • Feasibility of mobile application scale, derived from UMUX format

    Post-Intervention (Week 3)

  • Engagement with IMFAB protocol scale, derived from UMUX format.

    Post-Intervention (Week 3)

Other Outcomes (1)

  • Gratitude Text Responses - Qualitative

    Days 2, 4, 6, 8, 10, and 12

Study Arms (3)

Functionality Mirror Exposure & Journal

EXPERIMENTAL

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

Pure Mirror Exposure & Gratitude Journal

ACTIVE COMPARATOR

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

Assessment only control

NO INTERVENTION

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

Interventions

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)

Functionality Mirror Exposure & JournalPure Mirror Exposure & Gratitude Journal

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must self-identify as female.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergraduate female aged 18-23 years.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University at Albany, State University of New York

Albany, New York, 12222, United States

Location

Union College

Schenectady, New York, 12308, United States

Location

Related Publications (8)

  • 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.

    PMID: 16864251BACKGROUND
  • 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.

    PMID: 3761129BACKGROUND
  • 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.

    PMID: 25462882BACKGROUND
  • 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.

    PMID: 11920995BACKGROUND
  • 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.

    PMID: 28822275BACKGROUND
  • 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.

    PMID: 10887758BACKGROUND
  • 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.

    PMID: 15023093BACKGROUND
  • 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.

    PMID: 21443367BACKGROUND

Study Officials

  • D. Catherine Walker

    Union College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of two active conditions or a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Assistant Professor

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 8, 2019

Study Start

April 1, 2018

Primary Completion

July 1, 2021

Study Completion

December 1, 2021

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
6 months after initial publication of data analyses from the current study.
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.

Locations