Eating DisorderNCT03758326
A New Measure of Body Image in Eating Disorders
A study testing Body App in people with Eating Disorder, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder
- What is being tested?
- Body App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 64 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- No current psychiatric diagnosis
- Body mass index greater than or equal to 14
- Independently ambulatory
- Possession of a smartphone with data plan
- English proficiency
Who cannot join
- Active suicidal ideation
- Comorbid schizophrenia spectrum or other psychotic disorder.
- Healthy comparison group:
- Body mass index > 41
- Active suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74133
About this study
Official title: Measurement of Body Image in Eating Disorders
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.
Read the 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.
- Conditions
- Eating Disorder
- Being tested
- Body App
- Keywords
- Body image
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body AppOther
Participants will indicate areas of concern on a virtual manikin using an electronic online interface. Body measurements will also be collected.
| Study group | Role | What they receive |
|---|---|---|
| Eating disorder | Other | Measurement of body image via Body App and relationship to body measurement Receives: Other: Body App |
| Healthy comparison | Other | Measurement of body image via Body App and relationship to body measurement Receives: Other: Body App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body image distortion score on the Body App Tool
Discrepancy between subjective body estimation on avatar and actual measurement of corresponding body part
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
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)
Measured: Through study completion, an average of 1 year
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)
Measured: Through study completion, an average of 1 year
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)
Measured: Through study completion, an average of 1 year
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)
Measured: Through study completion, an average of 1 year
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)
Measured: Through study completion, an average of 1 year
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)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start16 Mar 2018
- Primary completion30 Aug 2022
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahib Khalsa, MD, PhD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758326
- Sponsor's protocol ID
- 2018-001-01
- Status last verified
- Oct 2023
- First submitted
- 19 Mar 2018
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Body Image in Eating Disorders
- ClinicalTrials.gov ID
- NCT03758326
- Acronym / sponsor ID
- 2018-001-01
- Conditions
- Eating Disorder
- Keywords
- Body image
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eating disorder | Other | Other: Body AppMeasurement of body image via Body App and relationship to body measurement |
| Healthy comparison | Other | Other: Body AppMeasurement of body image via Body App and relationship to body measurement |
Who may qualify
- Ages
- 13 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- Active suicidal ideation
- Comorbid schizophrenia spectrum or other psychotic disorder.
- Body mass index > 41
- Active suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body AppParticipants will indicate areas of concern on a virtual manikin using an electronic online interface. Body measurements will also be collected. | Other | Eating disorder, Healthy comparison |
Primary outcome
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
6 secondary outcomes
Body image dissatisfaction score on the Photographic Figure Rating Scale
Time frame: 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
Eating disorder severity on the Eating Disorder Examination Questionnaire
Time frame: 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
Body dysmorphic concerns on the Dysmorphic Concerns Questionnaire
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahib Khalsa, MD, PhD principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body App in people with Eating Disorder, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body image distortion score on the Body App Tool (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.