- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03758326
A New Measure of Body Image in Eating Disorders
Measurement of Body Image in Eating Disorders
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
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Tulsa, Oklahoma, United States, 74133
- Laureate Institute for Brain Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Eating disorder
Measurement of body image via Body App and relationship to body measurement
|
Participants will indicate areas of concern on a virtual manikin using an electronic online interface.
Body measurements will also be collected.
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Other: Healthy comparison
Measurement of body image via Body App and relationship to body measurement
|
Participants will indicate areas of concern on a virtual manikin using an electronic online interface.
Body measurements will also be collected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body image distortion score on the Body App Tool
Time Frame: Through study completion, an average of 1 year
|
Discrepancy between subjective body estimation on avatar and actual measurement of corresponding body part
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body image dissatisfaction score on the Photographic Figure Rating Scale
Time Frame: Through study completion, an average of 1 year
|
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)
|
Through study completion, an average of 1 year
|
Body image disturbance on the Body Appreciation Scale-2
Time Frame: Through study completion, an average of 1 year
|
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)
|
Through study completion, an average of 1 year
|
Eating disorder severity on the Eating Disorder Examination Questionnaire
Time Frame: Through study completion, an average of 1 year
|
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)
|
Through study completion, an average of 1 year
|
Body image disturbance on the Body Image States Scale
Time Frame: Through study completion, an average of 1 year
|
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)
|
Through study completion, an average of 1 year
|
Body dysmorphic concerns on the Dysmorphic Concerns Questionnaire
Time Frame: Through study completion, an average of 1 year
|
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)
|
Through study completion, an average of 1 year
|
Exercise addiction on the Exercise Addiction Inventory
Time Frame: Through study completion, an average of 1 year
|
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)
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sahib Khalsa, MD, PhD, Laureate Institute for Brain Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-001-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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