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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03758326
Other study ID # 2018-001-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 16, 2018
Est. completion date November 30, 2024

Study information

Verified date October 2023
Source Laureate Institute for Brain Research, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 135
Est. completion date November 30, 2024
Est. primary completion date August 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 13 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Body App
Participants will indicate areas of concern on a virtual manikin using an electronic online interface. Body measurements will also be collected.

Locations

Country Name City State
United States Laureate Institute for Brain Research Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Laureate Institute for Brain Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body image distortion score on the Body App Tool Discrepancy between subjective body estimation on avatar and actual measurement of corresponding body part Through study completion, an average of 1 year
Secondary 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) Through study completion, an average of 1 year
Secondary 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) Through study completion, an average of 1 year
Secondary 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) Through study completion, an average of 1 year
Secondary 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) Through study completion, an average of 1 year
Secondary 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) Through study completion, an average of 1 year
Secondary 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) Through study completion, an average of 1 year
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