NCT04126239

Brief Summary

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.

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
1,610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

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

October 7, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2023

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

October 11, 2019

Last Update Submit

June 17, 2021

Conditions

Keywords

food AddictionObesity

Outcome Measures

Primary Outcomes (4)

  • FAST score

    Screening test to validate

    Baseline

  • YFAS 2.0

    Screening test to validate DSM-5 Yale Food Addiction Scale (YFAS 2.0)

    Baseline

  • BES score

    Binge Eating Scale scoring

    Baseline

  • DEBQ score

    Dutch Eating Behaviour Questionnaire scoring

    Baseline

Study Arms (2)

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

Other: Online survey - questionnaire

healthy volunteer

Other: Online survey - questionnaire

Interventions

Online survey - questionnaire

Participant suffering from obesityhealthy volunteer

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* BMI ≥ 30 * Able to consent

You may qualify if:

  • BMI ≥ 30
  • Able to consent

You may not qualify if:

  • Non-french speaker
  • Patient unable to use internet tools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

RECRUITING

MeSH Terms

Conditions

Food AddictionObesity

Condition Hierarchy (Ancestors)

Behavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorFeeding and Eating DisordersMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sylvain ICETA, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR
  • Emmanuel Disse, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain ICETA, MD

CONTACT

Emmanuel Disse, PR

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 15, 2019

Study Start

October 7, 2019

Primary Completion

October 17, 2022

Study Completion

June 17, 2023

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations