ObesityADDICTALNCT04218097
Food Addiction and Follow-up in Subjects With Obesity
An observational study of Obesity and Eating Disorders, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Obesity is a chronic disease. Its prevalence, which is constantly increasing, as well as the morbidity and mortality caused, require the development of new treatments, particularly for associated eating disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Eating Disorders, Food Addiction
- What is being tested?
- Study questionnaire
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2020to 1 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients grade 2 and 3, Hospitalized in Endocrinology A from January 1, 2017 to January 1, 2018
Who may be able to join
- Obese patients grade 2 and 3
- Hospitalized in Endocrinology A from January 1, 2017 to January 1, 2018
- Over 18 years of age
- Not objecting to its participation
Who cannot join
- No understanding of French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Follow-up in Subjects With Obesity and Food Addiction
Obesity is a chronic disease. Its prevalence, which is constantly increasing, as well as the morbidity and mortality caused, require the development of new treatments, particularly for associated eating disorders. Indeed, it has been shown that a participation of abnormalities of food addiction type behaviour was frequently found in patients hospitalized for obesity (25% of patients). These disorders require specific management if you want to achieve a good weight result. The aim of the study is to compare the weight evolution of patients with addiction-type disorder (addict) versus those without addiction (non-addict) as well as the management modalities.
- Conditions
- Obesity, Eating Disorders, Food Addiction
- Being tested
- Study questionnaire
- Medical subject headings
- Obesity, Feeding and Eating Disorders, Food Addiction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study questionnaireOther
Monitoring - data collection: Sending of an information form and the study questionnaire, the YFAS and Hospital Anxiety and Depression (HAD) scale by post within a follow-up period of 24 to 36 months. With a stamped envelope for the answer and a telephone reminder if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Addict patients | Obese type 2 and 3 with food addict according to the Yale Food Addiction Scale (YFAS) questionnaire.
Cohort design: identification of patients treated in hospital for obesity assessment over the period 1 January 2017 to 1 January 2018 whose addictive or non-addictive status was characterised by the YFAS questionnaire. To talk about food addiction, the person must have at least 3 out of 7 positive criteria AND also meet the "marked suffering" criterion. Receives: Other: Study questionnaire | |
| Control patients | Obese type 2 and 3, non food addict Cohort design: identification of patients treated in hospital for obesity assessment over the period 1 January 2017 to 1 January 2018 whose addictive or non-addictive status was characterised by the YFAS questionnaire. To talk about food addiction, the person must have at least 3 out of 7 positive criteria AND also meet the "marked suffering" criterion. Receives: Other: Study questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change: difference between the current weight reported in a questionnaire and the weight measured at the end of hospitalization
Evaluate the weight evolution of patients according to their addictive or non-addictive nature, 24-36 months after their discharge from hospital, in Endocrinology for initial obesity assessment.
Measured: month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start30 Mar 2020
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine LAVILLE, PR, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218097
- Sponsor's protocol ID
- 69HCL19_0401
- Acronym
- ADDICTAL
- Status last verified
- Aug 2022
- First submitted
- 19 Dec 2019
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Follow-up in Subjects With Obesity and Food Addiction
- ClinicalTrials.gov ID
- NCT04218097
- Acronym / sponsor ID
- ADDICTAL / 69HCL19_0401
- Conditions
- Obesity, Eating Disorders, Food Addiction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 6 Jan 2020 (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.
Obesity is a chronic disease. Its prevalence, which is constantly increasing, as well as the morbidity and mortality caused, require the development of new treatments, particularly for associated eating disorders. Indeed, it has been shown that a participation of abnormalities of food addiction type behaviour was frequently found in patients hospitalized for obesity (25% of patients). These disorders require specific management if you want to achieve a good weight result. The aim of the study is to compare the weight evolution of patients with addiction-type disorder (addict) versus those without addiction (non-addict) as well as the management modalities.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Addict patients | – | Other: Study questionnaireObese type 2 and 3 with food addict according to the Yale Food Addiction Scale (YFAS) questionnaire. Cohort design: identification of patients treated in hospital for obesity assessment over the period 1 January 2017 to 1 January 2018 whose addictive or non-addictive status was characterised by the YFAS questionnaire. To talk about food addiction, the person must have at least 3 out of 7 positive criteria AND also meet the "marked suffering" criterion. |
| Control patients | – | Other: Study questionnaireObese type 2 and 3, non food addict Cohort design: identification of patients treated in hospital for obesity assessment over the period 1 January 2017 to 1 January 2018 whose addictive or non-addictive status was characterised by the YFAS questionnaire. To talk about food addiction, the person must have at least 3 out of 7 positive criteria AND also meet the "marked suffering" criterion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients grade 2 and 3, Hospitalized in Endocrinology A from January 1, 2017 to January 1, 2018
Key inclusion criteria (4 listed)
- Obese patients grade 2 and 3
- Hospitalized in Endocrinology A from January 1, 2017 to January 1, 2018
- Over 18 years of age
- Not objecting to its participation
Key exclusion criteria (1 listed)
- No understanding of French
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 |
|---|---|---|
| Study questionnaireMonitoring - data collection: Sending of an information form and the study questionnaire, the YFAS and Hospital Anxiety and Depression (HAD) scale by post within a follow-up period of 24 to 36 months. With a stamped envelope for the answer and a telephone reminder if necessary. | Other | Addict patients, Control patients |
Primary outcome
Weight change: difference between the current weight reported in a questionnaire and the weight measured at the end of hospitalization
Time frame: month 36
Evaluate the weight evolution of patients according to their addictive or non-addictive nature, 24-36 months after their discharge from hospital, in Endocrinology for initial obesity assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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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.
Martine LAVILLE, PR study director
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 Obesity and Eating Disorders, 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 4 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change: difference between the current weight reported in a questionnaire and the weight measured at the end of hospitalization (time frame: month 36). 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 4 Aug 2022.