Clinical trial NCT03758326: A New Measure of Body Image in Eating Disorders
Official title: Measurement of Body Image in Eating Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Eating Disorder
Keywords: Body image
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 135
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Body image distortion score on the Body App Tool
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Body image dissatisfaction score on the Photographic Figure Rating Scale
timeFrame: Through study completion, an average of 1 year
measure: Body image disturbance on the Body Appreciation Scale-2
timeFrame: Through study completion, an average of 1 year
measure: Eating disorder severity on the Eating Disorder Examination Questionnaire
timeFrame: Through study completion, an average of 1 year
measure: Body image disturbance on the Body Image States Scale
timeFrame: Through study completion, an average of 1 year
measure: Body dysmorphic concerns on the Dysmorphic Concerns Questionnaire
timeFrame: Through study completion, an average of 1 year
measure: Exercise addiction on the Exercise Addiction Inventory
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: Sahib Khalsa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: