A New Measure of Body Image in Eating Disorders
Primary Purpose
Eating Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body App
Sponsored by
About this trial
This is an interventional diagnostic trial for Eating Disorder focused on measuring Body image
Eligibility Criteria
Eating disorders group:
Inclusion Criteria:
- Primary clinical diagnosis of eating disorder
- Receiving inpatient treatment for eating disorder
- Body mass index greater than or equal to 14
- Independently ambulatory
- Possession of a smartphone with data plan
- English proficiency
Exclusion Criteria:
- Active suicidal ideation
- Comorbid schizophrenia spectrum or other psychotic disorder.
Healthy comparison group:
Inclusion Criteria:
- No current psychiatric diagnosis
- Body mass index greater than or equal to 14
- Independently ambulatory
- Possession of a smartphone with data plan
- English proficiency
Exclusion Criteria:
- Body mass index > 41
- Active suicidal ideation
Sites / Locations
- Laureate Institute for Brain Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Eating disorder
Healthy comparison
Arm Description
Measurement of body image via Body App and relationship to body measurement
Measurement of body image via Body App and relationship to body measurement
Outcomes
Primary Outcome Measures
Body image distortion score on the Body App Tool
Discrepancy between subjective body estimation on avatar and actual measurement of corresponding body part
Secondary Outcome Measures
Body image dissatisfaction score on the Photographic Figure Rating Scale
Average of the absolute change in body image dissatisfaction across each measurement (score range: 0 to 10; larger changes indicate greater severity of body image dissatisfaction)
Body image disturbance on the Body Appreciation Scale-2
Average of the absolute change in body image disturbance across each measurement relative to baseline (range 10 to 50, higher scores indicating reduced severity of body image disturbance)
Eating disorder severity on the Eating Disorder Examination Questionnaire
Average of the absolute change in overall eating disorder severity across each measurement relative to baseline (range 0 to 6, larger scores indicate greater severity of eating disorder)
Body image disturbance on the Body Image States Scale
Average of the absolute change in body image disturbance across each measurement relative to baseline (range 0 to 48, higher scores indicate greater severity of body image disturbance)
Body dysmorphic concerns on the Dysmorphic Concerns Questionnaire
Average of the absolute change in dysmorphic concerns across each measurement relative to baseline (range 0 to 21, higher scores indicate greater severity of dysmorphic concerns)
Exercise addiction on the Exercise Addiction Inventory
Average of the absolute change in exercise addiction across each measurement relative to baseline (range 6 to 30, higher scores indicate greater severity of exercise addiction)
Full Information
NCT ID
NCT03758326
First Posted
March 19, 2018
Last Updated
October 4, 2023
Sponsor
Laureate Institute for Brain Research, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03758326
Brief Title
A New Measure of Body Image in Eating Disorders
Official Title
Measurement of Body Image in Eating Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laureate Institute for Brain Research, Inc.
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
This study aims to compare a new electronic instrument called (here referred to as the 'Body App') with traditional paper and pencil rating scales for assessing how individuals with eating disorders evaluate their body image.
Detailed Description
Self-perceived weight or shape disturbance is a core symptom of eating disorders, with heavy therapeutic and prognostic relevance. Developing a reliable and unbiased method to assess body image disturbance is imperative, as feature characteristics of eating disorders, such as anorexia nervosa, include the overestimation of body size and shape. Among the most essential features of the disorder, this inability to correctly judge one's own body image has been frequently linked to the maintenance of eating disorders. Moreover, persistent perceptual disturbance for one's visual appearance is one of the strong predictors of relapse in AN and bulimia nervosa.
Body image disturbance can be conceptualized as having two main components: perceptual, and attitudinal/affective. These might be considered two distinct constructs, best measured independently. However, clinicians currently rely upon self-report questionnaires that evaluate aggregates of symptoms, perceptual experiences, behaviors, and thoughts linked to the disorder. Some scales selectively evaluate body image characteristics such as body dissatisfaction and body distortion. However, it is unclear to what degree each of these measures quantifies the specific components of perceptual experiences vs. attitudinal/affective aspects. This study aims to evaluate whether a new electronic instrument, here referred to as the 'Body App', which separates estimations of body shape and size from the attitudinal/affective component might result in closer approximations of the perceptual component of weight or shape disturbance, and facilitate the assessment of body image disturbance in eating disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder
Keywords
Body image
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eating disorder
Arm Type
Other
Arm Description
Measurement of body image via Body App and relationship to body measurement
Arm Title
Healthy comparison
Arm Type
Other
Arm Description
Measurement of body image via Body App and relationship to body measurement
Intervention Type
Other
Intervention Name(s)
Body App
Intervention Description
Participants will indicate areas of concern on a virtual manikin using an electronic online interface. Body measurements will also be collected.
Primary Outcome Measure Information:
Title
Body image distortion score on the Body App Tool
Description
Discrepancy between subjective body estimation on avatar and actual measurement of corresponding body part
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Body image dissatisfaction score on the Photographic Figure Rating Scale
Description
Average of the absolute change in body image dissatisfaction across each measurement (score range: 0 to 10; larger changes indicate greater severity of body image dissatisfaction)
Time Frame
Through study completion, an average of 1 year
Title
Body image disturbance on the Body Appreciation Scale-2
Description
Average of the absolute change in body image disturbance across each measurement relative to baseline (range 10 to 50, higher scores indicating reduced severity of body image disturbance)
Time Frame
Through study completion, an average of 1 year
Title
Eating disorder severity on the Eating Disorder Examination Questionnaire
Description
Average of the absolute change in overall eating disorder severity across each measurement relative to baseline (range 0 to 6, larger scores indicate greater severity of eating disorder)
Time Frame
Through study completion, an average of 1 year
Title
Body image disturbance on the Body Image States Scale
Description
Average of the absolute change in body image disturbance across each measurement relative to baseline (range 0 to 48, higher scores indicate greater severity of body image disturbance)
Time Frame
Through study completion, an average of 1 year
Title
Body dysmorphic concerns on the Dysmorphic Concerns Questionnaire
Description
Average of the absolute change in dysmorphic concerns across each measurement relative to baseline (range 0 to 21, higher scores indicate greater severity of dysmorphic concerns)
Time Frame
Through study completion, an average of 1 year
Title
Exercise addiction on the Exercise Addiction Inventory
Description
Average of the absolute change in exercise addiction across each measurement relative to baseline (range 6 to 30, higher scores indicate greater severity of exercise addiction)
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Eligibility is based on self-representation of gender identity.
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Eating disorders group:
Inclusion Criteria:
Primary clinical diagnosis of eating disorder
Receiving inpatient treatment for eating disorder
Body mass index greater than or equal to 14
Independently ambulatory
Possession of a smartphone with data plan
English proficiency
Exclusion Criteria:
Active suicidal ideation
Comorbid schizophrenia spectrum or other psychotic disorder.
Healthy comparison group:
Inclusion Criteria:
No current psychiatric diagnosis
Body mass index greater than or equal to 14
Independently ambulatory
Possession of a smartphone with data plan
English proficiency
Exclusion Criteria:
Body mass index > 41
Active suicidal ideation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahib Khalsa, MD, PhD
Organizational Affiliation
Laureate Institute for Brain Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laureate Institute for Brain Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A New Measure of Body Image in Eating Disorders
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