- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04126239
Validation of a Food Addiction Screening Test (FAST - FR)
June 17, 2021 updated by: Hospices Civils de Lyon
Validation Study of a Rapid Screening Test of Food Addiction in Patients Suffering From Obesity and Healthy Volunteer
Food addiction (FA) is a behavioral addiction characterized by a high consumption of palatable foods, which markedly activate the reward system, despite adverse consequences.
FA was first described in 1956 but remains controversial.
The Yale Food Addiction Scale (YFAS), developed by Gearhardt et al. in 2009, is currently regarded as the "Gold Standard" for FA screening.
In a previous study, we established a Food Addiction Screening Test using artificial intelligence.
The main objective of the present study is to validate the sensitivity, specificity and precision for FA diagnosis in a sample of patient suffering from obesity and healthy volunteers.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1610
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sylvain ICETA, MD
- Phone Number: +33 4 27 85 60 11
- Email: sylvain.iceta@gmail.com
Study Contact Backup
- Name: Emmanuel Disse, PR
- Email: emmanuel.disse@chu-lyon.fr
Study Locations
-
-
-
Pierre-Bénite, France
- Recruiting
- Centre Hospitalier Lyon Sud
-
Contact:
- Sylvain ICETA, MD
-
Contact:
- Emmanuel DISSE, PR
-
Principal Investigator:
- Sylvain Iceta, MD
-
Sub-Investigator:
- Emmanuel DISSE, PR
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- BMI ≥ 30
- Able to consent
Description
Inclusion Criteria:
- BMI ≥ 30
- Able to consent
Exclusion Criteria:
- Non-french speaker
- Patient unable to use internet tools
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participant suffering from obesity
Patient, male or female, over 18 and under 70 years old Patient group with a Body Mass Index (BMI) greater than or equal to 30 kg / m2
|
Online survey - questionnaire
|
healthy volunteer
|
Online survey - questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FAST score
Time Frame: Baseline
|
Screening test to validate
|
Baseline
|
YFAS 2.0
Time Frame: Baseline
|
Screening test to validate DSM-5 Yale Food Addiction Scale (YFAS 2.0)
|
Baseline
|
BES score
Time Frame: Baseline
|
Binge Eating Scale scoring
|
Baseline
|
DEBQ score
Time Frame: Baseline
|
Dutch Eating Behaviour Questionnaire scoring
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sylvain ICETA, MD, Hospices Civils de Lyon
- Principal Investigator: Emmanuel Disse, Pr, Hospices Civils de Lyon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2019
Primary Completion (Anticipated)
October 17, 2022
Study Completion (Anticipated)
June 17, 2023
Study Registration Dates
First Submitted
October 11, 2019
First Submitted That Met QC Criteria
October 11, 2019
First Posted (Actual)
October 15, 2019
Study Record Updates
Last Update Posted (Actual)
June 18, 2021
Last Update Submitted That Met QC Criteria
June 17, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL19_0320
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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