Food AddictionFAST - FRNCT04126239
Validation of a Food Addiction Screening Test
An observational study of Food Addiction and Obesity, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Addiction, Obesity
- What is being tested?
- Online survey - questionnaire
- How many people
- 1,610 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2019to 17 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * BMI ≥ 30 * Able to consent
Who may be able to join
- BMI ≥ 30
- Able to consent
Who cannot join
- Non-french speaker
- Patient unable to use internet tools
Trial locations and contacts
1 site in 1 country.
Emmanuel Disse, PR contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite
Sylvain ICETA, MD
Emmanuel DISSE, PR
About this study
Official title: 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.
- Conditions
- Food Addiction, Obesity
- Being tested
- Online survey - questionnaire
- Keywords
- food Addiction, Obesity
- Medical subject headings
- Food Addiction, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online survey - questionnaireOther
Online survey - questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Online survey - questionnaire | |
| healthy volunteer | Not described Receives: Other: Online survey - questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAST score
Screening test to validate
Measured: Baseline
YFAS 2.0
Screening test to validate DSM-5 Yale Food Addiction Scale (YFAS 2.0)
Measured: Baseline
BES score
Binge Eating Scale scoring
Measured: Baseline
DEBQ score
Dutch Eating Behaviour Questionnaire scoring
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start7 Oct 2019
- Primary completion17 Oct 2022 (estimated)
- Study completion17 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AddictionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain ICETA, MD, Principal investigator, Hospices Civils de LyonEmmanuel Disse, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126239
- Sponsor's protocol ID
- 69HCL19_0320
- Acronym
- FAST - FR
- Status last verified
- Jun 2021
- First submitted
- 11 Oct 2019
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of a Rapid Screening Test of Food Addiction in Patients Suffering From Obesity and Healthy Volunteer
- ClinicalTrials.gov ID
- NCT04126239
- Acronym / sponsor ID
- FAST - FR / 69HCL19_0320
- Conditions
- Food Addiction, Obesity
- Keywords
- food Addiction, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,610 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 17 Oct 2022 (estimated)
- Study completion
- 17 Jun 2023 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant suffering from obesity | – | Other: Online survey - questionnairePatient, 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 |
| healthy volunteer | – | Other: Online survey - questionnaire |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * BMI ≥ 30 * Able to consent
Key inclusion criteria (2 listed)
- BMI ≥ 30
- Able to consent
Key exclusion criteria (2 listed)
- Non-french speaker
- Patient unable to use internet tools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online survey - questionnaireOnline survey - questionnaire | Other | Participant suffering from obesity, healthy volunteer |
Primary outcome
FAST score
Time frame: Baseline
Screening test to validate
YFAS 2.0
Time frame: Baseline
Screening test to validate DSM-5 Yale Food Addiction Scale (YFAS 2.0)
BES score
Time frame: Baseline
Binge Eating Scale scoring
DEBQ score
Time frame: Baseline
Dutch Eating Behaviour Questionnaire scoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Disse, PR contact
Sylvain ICETA, MD principal investigator
Hospices Civils de Lyon
Emmanuel Disse, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Addiction and Obesity, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvain ICETA, MD (4 27 85 60 11 ext. +33, sylvain.iceta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAST score (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.