NCT03758326

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

4.5 years

First QC Date

March 19, 2018

Last Update Submit

October 4, 2023

Conditions

Eating Disorder

Keywords

Body image

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Body image dissatisfaction score on the Photographic Figure Rating Scale

    Through study completion, an average of 1 year

  • Body image disturbance on the Body Appreciation Scale-2

    Through study completion, an average of 1 year

  • Eating disorder severity on the Eating Disorder Examination Questionnaire

    Through study completion, an average of 1 year

  • Body image disturbance on the Body Image States Scale

    Through study completion, an average of 1 year

  • Body dysmorphic concerns on the Dysmorphic Concerns Questionnaire

    Through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (2)

Eating disorder

OTHER

Measurement of body image via Body App and relationship to body measurement

Other: Body App

Healthy comparison

OTHER

Measurement of body image via Body App and relationship to body measurement

Other: Body App

Interventions

Body AppOTHER

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

Eating disorderHealthy comparison

Eligibility Criteria

Age13 Years - 64 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is based on self-representation of gender identity.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Active suicidal ideation
  • Comorbid schizophrenia spectrum or other psychotic disorder.
  • Healthy comparison group:
  • No current psychiatric diagnosis
  • Body mass index greater than or equal to 14
  • Independently ambulatory
  • Possession of a smartphone with data plan
  • English proficiency
  • Body mass index \> 41
  • Active suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74133, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Sahib Khalsa, MD, PhD

    Laureate Institute for Brain Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

November 29, 2018

Study Start

March 16, 2018

Primary Completion

August 30, 2022

Study Completion

November 30, 2024

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)