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EXPALI: EXPert System, ALImentary

Sponsor
Marie-Pierre TAVOLACCI (Other)
Overall Status
Completed
CT.gov ID
NCT03208699
Collaborator
(none)
256
Enrollment
3
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    256 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Screening and Diagnosis Help of Eating Disorders
    Actual Study Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    Oct 1, 2015
    Actual Study Completion Date :
    Dec 31, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Sensivity and specificity of the clinical algorithm [inclusion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • eating disorders

    • SCOFF test = 2 or more

    Exclusion Criteria:

    • no eating disorders

    • SCOFF test = 0 or 1

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Marie-Pierre TAVOLACCI

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marie-Pierre TAVOLACCI, Docteur, University Hospital, Rouen
    ClinicalTrials.gov Identifier:
    NCT03208699
    Other Study ID Numbers:
    • 2017/124/OB
    First Posted:
    Jul 5, 2017
    Last Update Posted:
    Jul 6, 2017
    Last Verified:
    Jul 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marie-Pierre TAVOLACCI, Docteur, University Hospital, Rouen
    anorexia
    bulimia
    Additional relevant MeSH terms:
    Feeding and Eating Disorders

    Study Results

    No Results Posted as of Jul 6, 2017