NCT03208699

Brief Summary

Eating disorders (ED) are often undetected in the general population resulting in delayed treatment. The SCOFF questionnaire has been validated for eating disorders screening in primary care, but does not identify the type of eating disorder. Objective: Investigators evaluated the performance of a clinical algorithm (ExpaliTM) combining answers to SCOFF questionnaire with Body Mass Index (BMI) to identify four Broad Categories of ED derived from DSM-5. Design: Clinical algorithm (ExpaliTM) was developped from 104 combinations of BMI levels and answers to five SCOFF questions. Two senior ED specialists allocated each combination to one of the four Broad Categories of ED (DSM-5 diagnostics): restrictive disorder (anorexia nervosa typical, atypical and restrictive food intake disorders), bulimic disorder (typical and with low frequency or duration), hyperphagic disorder (binge eating disorders typical and with low frequency or duration) and other specified ED. The performance of ExpaliTM was evaluated on data from patients referred to the Nutrition Department including a precise DSM-5 diagnosis of ED, a positive SCOFF test (at least 2 "yes" answers) and BMI. Sensitivity, specificity values with a 95% confidence interval (95% CI) and Youden index were calculated for each category.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Status
completed

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

October 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

Same day

First QC Date

July 3, 2017

Last Update Submit

July 4, 2017

Conditions

Eating Disorder Symptom

Keywords

anorexiabulimia

Outcome Measures

Primary Outcomes (1)

  • Sensivity and specificity of the clinical algorithm

    inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients recruited in the Nutrition Department of Rouen University Hospital (France) for suspicion of Eating disorders

You may qualify if:

  • eating disorders
  • SCOFF test = 2 or more

You may not qualify if:

  • no eating disorders
  • SCOFF test = 0 or 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AnorexiaBulimia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsHyperphagia

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Docteur

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 5, 2017

Study Start

October 1, 2015

Primary Completion

October 1, 2015

Study Completion

December 31, 2015

Last Updated

July 6, 2017

Record last verified: 2017-07