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NCT03208699 Clinical Trial

EXPert System, ALImentary

Eating Disorder Symptom Clinical Trial

— EXPALI  

Official title:
Screening and Diagnosis Help of Eating Disorders

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03208699
Other study ID # 2017/124/OB
Secondary ID
Status Completed
Phase N/A
First received July 3, 2017
Last updated July 4, 2017
Start date October 1, 2015
Est. completion date December 31, 2015

Study information
Verified date July 2017
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 256
Est. completion date December 31, 2015
Est. primary completion date October 1, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- eating disorders

- SCOFF test = 2 or more

Exclusion Criteria:

- no eating disorders

- SCOFF test = 0 or 1

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Marie-Pierre TAVOLACCI

Outcome
Type Measure Description Time frame Safety issue
Primary Sensivity and specificity of the clinical algorithm inclusion
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