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ObesityADOBNCT04613791

Situation and Evolution of the Misuse of Alcohol and Other Addictive Behaviors in Obese Patients Being Managed at Nîmes University Hospital

An observational study of Obesity, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Obesity is a multifactorial pathology in which external (lifestyle, environment) and internal (psychological or biological, especially genetic) factors are involved. These are responsible for a positive energy balance. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Blood test
How many people
800 participants
Where
1 siteFrance
Study dates
16 Feb 2021to 15 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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: The target population for this study corresponds to all patients being managed for obesity (Body Mass Index ≥ 30 kg.m-²). The source population for this study corresponds to all patients being managed by the obesity clinic at Nîmes University Hospital for obesity with a BMI ≥ 30 kg.m-² at the time of their first visit (complete hospitalization outpatients or consultation) for initiation to management (incident subjects).

Who may be able to join

None listed.

Who cannot join

  • Patient with psychiatric disorder reducing capacity for comprehension.
  • Patient in an exclusion period determined by another study.
  • Patient under legal guardianship, tutorship or curatorship.
  • Patient to whom it is impossible to give clear information
  • Patient who is pregnant, about to give birth or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • CHU de Nimes

    Nîmes

    Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr

    Emma LUCQUIAUD, Dr.

    Recruiting

Other trials in France

About this study

Obesity is a multifactorial pathology in which external (lifestyle, environment) and internal (psychological or biological, especially genetic) factors are involved. These are responsible for a positive energy balance. One of the external factors that can intervene in the genesis of obesity is the existence of eating disorders: bulimic hyperphagia. Some teams consider bulimic hyperphagia as a form of addiction. After bariatric surgery, the appearance of new addictions has been observed.

In connection with Pr Perney's addictology department, the investigators have observed that some patients under treatment for obesity at the endocrinology department subsequently developed other addictions, in particular misuse of alcohol.

Read more

The hypotheses of this research are :

There appears to be a transfer from eating disorders to substance misuse addiction in post-treatment of obesity, particularly in patients who have undergone bariatric surgery.

The misuse of addictive substances most concerned by this transfer of addiction in the post-treatment of obesity, particularly after bariatric surgery, seems to be the misuse of alcohol.

This will be the first French cohort study on addictive behaviors in patients undergoing bariatric surgery and the first international study including non-operated obese patients benefiting from medical care alone. This study will improve the multidisciplinary management of these patients by integrating addictologists.

Conditions
Obesity
Being tested
Blood test
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood testBiological

    Also called Distribution of the following questionnaires: AUDIT, CAST, HADS, BES, Fagerstrom test and the EQVOD scale

    Collection of epidemio-clinical, biological, radiological and therapeutic patient data. Study samples collected from 154 patients to determine whether a particular immune profile could identify individuals prone to insulin resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.

    The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends). Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points. This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.

    Measured: Day 0

  2. Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.

    The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends).Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points. This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.

    Measured: Month 12

  3. Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.

    The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends). Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points.This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.

    Measured: Month 24

  4. Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire

    The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.

    Measured: Day 0

  5. Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire

    The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.

    Measured: Month 12

  6. Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire

    The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.

    Measured: Month 24

Secondary outcomes (33)
  1. Smoking (tobacco addiction) according to the Fagerström test

    The Fagerström test consists of six questions. A score of 0 - 10 is obtained depending on the answers given. A score of 0 - 2 = zero addiction, 3 - 4 = slight addiction, 5 - 6 = moderate addiction, 7 ou 8 heavy addiction and 9 - 10 = very heavy addiction.

    Measured: Day 0

  2. Smoking (tobacco addiction) according to the Fagerström test

    The Fagerström test consists of six questions. A score of 0 - 10 is obtained depending on the answers given. A score of 0 - 2 = zero addiction, 3 - 4 = slight addiction, 5 - 6 = moderate addiction, 7 ou 8 heavy addiction and 9 - 10 = very heavy addiction.

    Measured: Month 12

  3. Smoking (tobacco addiction) according to the Fagerström test

    The Fagerström test consists of six questions. A score of 0 - 10 is obtained depending on the answers given. A score of 0 - 2 = zero addiction, 3 - 4 = slight addiction, 5 - 6 = moderate addiction, 7 ou 8 heavy addiction and 9 - 10 = very heavy addiction.

    Measured: Month 24

  4. Cannabis addiction

    The Cannabis Abuse Screening Test (CAST) questionnaire has 6 questions to which the answer YES (=1) or NO (=0) is given. A score ≥ 3 on the CAST indicates addiction to Cannabis.

    Measured: Day 0

  5. Cannabis addiction

    The Cannabis Abuse Screening Test (CAST) questionnaire has 6 questions to which the answer YES (=1) or NO (=0) is given. A score ≥ 3 on the CAST indicates addiction to Cannabis.

    Measured: Month 12

  6. Cannabis addiction

    The Cannabis Abuse Screening Test (CAST) questionnaire has 6 questions to which the answer YES (=1) or NO (=0) is given. A score ≥ 3 on the CAST indicates addiction to Cannabis.

    Measured: Month 24

  7. Use of cocaine

    The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No

    Measured: Day 0

  8. Use of cocaine

    The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No

    Measured: Month 12

  9. Use of cocaine

    The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No

    Measured: Month 24

  10. Use of amphetamines

    The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No

    Measured: Day 0

  11. Use of amphetamines

    The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No

    Measured: Month 12

  12. Use of amphetamines

    The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No

    Measured: Month 24

  13. Use of opioids

    The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No

    Measured: Day 0

  14. Use of opioids

    The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No

    Measured: Month 12

  15. Use of opioids

    The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No

    Measured: Month 24

  16. Use of hallucinogenic drugs and/or new synthetic drugs

    The patient will be interviewed to find out whether he/she uses hallucinogenic drugs and/or new synthetic drugs. This will be noted as Yes/No

    Measured: Day 0

  17. Use of hallucinogenic drugs and/or new synthetic drugs

    The patient will be interviewed to find out whether he/she uses hallucinogenic drugs and/or new synthetic drugs. This will be noted as Yes/No

    Measured: Month 12

  18. Use of hallucinogenic drugs and/or new synthetic drugs

    The patient will be interviewed to find out whether he/she uses hallucinogenic drugs and/or new synthetic drugs. This will be noted as Yes/No

    Measured: Month 24

  19. Eating disorders

    A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.

    Measured: Day 0

  20. Eating disorders

    A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.

    Measured: Month 12

  21. Eating disorders

    A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.

    Measured: Month 24

  22. Comorbidities

    Presence of comorbidities for obesity (High blood pressure / Glucose intolerance or Diabetes / Sleep apnea syndrome / Dyslipidemia / Hepatic Steatosis / Cardiovascular diseases) will be noted from data in the patient file.

    Measured: Day 0

  23. Comorbidities

    Presence of comorbidities for obesity (High blood pressure / Glucose intolerance or Diabetes / Sleep apnea syndrome / Dyslipidemia / Hepatic Steatosis / Cardiovascular diseases) will be noted from data in the patient file.

    Measured: Month 12

  24. Comorbidities

    Presence of comorbidities for obesity (High blood pressure / Glucose intolerance or Diabetes / Sleep apnea syndrome / Dyslipidemia / Hepatic Steatosis / Cardiovascular diseases) will be noted from data in the patient file.

    Measured: Month 24

  25. Quality of Life according to the EQVOD scale

    The "Echelle de Qualité de Vie, Obésité et Diététique - EQVOD" (Quality of Life, Obesity and Dietetics Scale ) is a self-questionnaire validated in French which is adapted to the socio-cultural factors of obesity in France, making it possible to take into account the effects of dietary treatments on the quality of life of obese subjects (see Appendix 17.5) (Ziegler et al. 2005). It consists of 36 items, rated from 1 (always/highly) to 5 (never/not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sexual life - Q23-Q26, food well-being - Q27-Q31 and diet experience - Q32-Q36). The rating for each dimension is reported as 100. The closer the score is to 100, the better the quality of life related to that dimension.

    Measured: Day 0

  26. Quality of Life according to the EQVOD scale

    The "Echelle de Qualité de Vie, Obésité et Diététique - EQVOD" (Quality of Life, Obesity and Dietetics Scale ) is a self-questionnaire validated in French which is adapted to the socio-cultural factors of obesity in France, making it possible to take into account the effects of dietary treatments on the quality of life of obese subjects (see Appendix 17.5) (Ziegler et al. 2005). It consists of 36 items, rated from 1 (always/highly) to 5 (never/not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sexual life - Q23-Q26, food well-being - Q27-Q31 and diet experience - Q32-Q36). The rating for each dimension is reported as 100. The closer the score is to 100, the better the quality of life related to that dimension.

    Measured: Month 12

  27. Quality of Life according to the EQVOD scale

    The "Echelle de Qualité de Vie, Obésité et Diététique - EQVOD" (Quality of Life, Obesity and Dietetics Scale ) is a self-questionnaire validated in French which is adapted to the socio-cultural factors of obesity in France, making it possible to take into account the effects of dietary treatments on the quality of life of obese subjects (see Appendix 17.5) (Ziegler et al. 2005). It consists of 36 items, rated from 1 (always/highly) to 5 (never/not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sexual life - Q23-Q26, food well-being - Q27-Q31 and diet experience - Q32-Q36). The rating for each dimension is reported as 100. The closer the score is to 100, the better the quality of life related to that dimension.

    Measured: Month 24

  28. Anxiety and Depression

    The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that assesses depressive and anxiety symptomatology (excluding somatic symptoms) and measures severity in patients between 16 and 65 years of age from a hospital environment (Zigmong \& Snaith 1983, Snaith et al. 2003). The HADS consists of two parts: (a) 7 questions for screening for depression, and (b) 7 questions for screening for anxiety disorders. Each question receives a score between 0 and 3. The score for each part is obtained by adding the items that make up the part. The higher the score, the greater the severity of the corresponding symptoms.

    The French version was validated by Razavi et al. 1989 and Friedman et al. 2001.

    Measured: Day 0

  29. Anxiety and Depression

    The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that assesses depressive and anxiety symptomatology (excluding somatic symptoms) and measures severity in patients between 16 and 65 years of age from a hospital environment (Zigmong \& Snaith 1983, Snaith et al. 2003). The HADS consists of two parts: (a) 7 questions for screening for depression, and (b) 7 questions for screening for anxiety disorders. Each question receives a score between 0 and 3. The score for each part is obtained by adding the items that make up the part. The higher the score, the greater the severity of the corresponding symptoms.

    The French version was validated by Razavi et al. 1989 and Friedman et al. 2001.

    Measured: Month 12

  30. Anxiety and Depression

    The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that assesses depressive and anxiety symptomatology (excluding somatic symptoms) and measures severity in patients between 16 and 65 years of age from a hospital environment (Zigmong \& Snaith 1983, Snaith et al. 2003). The HADS consists of two parts: (a) 7 questions for screening for depression, and (b) 7 questions for screening for anxiety disorders. Each question receives a score between 0 and 3. The score for each part is obtained by adding the items that make up the part. The higher the score, the greater the severity of the corresponding symptoms.

    The French version was validated by Razavi et al. 1989 and Friedman et al. 2001.

    Measured: Month 24

  31. Binge eating

    The Binge Eating Scale (BES) is a self-administered questionnaire that diagnoses Binge Eating Disorder (BED) and assesses the behavioural, emotional and cognitive symptoms associated with Binge Eating Disorder in obese individuals (Gormally et al. 1982). It is composed of 16 items corresponding to groups of sentences including one to be selected from 3 to 4 propositions, which best describe how one feels. For each item, the subject has to choose the formulation that best corresponds to his current situation, which results in a score varying between 0 and 3 or between 0 and 2 for each item. Half of the items measure eating behaviours and the other half assess feelings or cognitions occurring during compulsive episodes. It gives a total score (from 0 to 46) that reflects the severity of the BED. A score greater than or equal to 18 indicates significant bulimic hyperphagia. The French version of this questionnaire was translated and validated by Brunault et al (2016).

    Measured: Day 0

  32. Binge eating

    The Binge Eating Scale (BES) is a self-administered questionnaire that diagnoses Binge Eating Disorder (BED) and assesses the behavioural, emotional and cognitive symptoms associated with Binge Eating Disorder in obese individuals (Gormally et al. 1982). It is composed of 16 items corresponding to groups of sentences including one to be selected from 3 to 4 propositions, which best describe how one feels. For each item, the subject has to choose the formulation that best corresponds to his current situation, which results in a score varying between 0 and 3 or between 0 and 2 for each item. Half of the items measure eating behaviours and the other half assess feelings or cognitions occurring during compulsive episodes. It gives a total score (from 0 to 46) that reflects the severity of the BED. A score greater than or equal to 18 indicates significant bulimic hyperphagia. The French version of this questionnaire was translated and validated by Brunault et al (2016).

    Measured: Month 12

  33. Binge eating

    The Binge Eating Scale (BES) is a self-administered questionnaire that diagnoses Binge Eating Disorder (BED) and assesses the behavioural, emotional and cognitive symptoms associated with Binge Eating Disorder in obese individuals (Gormally et al. 1982). It is composed of 16 items corresponding to groups of sentences including one to be selected from 3 to 4 propositions, which best describe how one feels. For each item, the subject has to choose the formulation that best corresponds to his current situation, which results in a score varying between 0 and 3 or between 0 and 2 for each item. Half of the items measure eating behaviours and the other half assess feelings or cognitions occurring during compulsive episodes. It gives a total score (from 0 to 46) that reflects the severity of the BED. A score greater than or equal to 18 indicates significant bulimic hyperphagia. The French version of this questionnaire was translated and validated by Brunault et al (2016).

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2020
  2. Study start16 Feb 2021
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion15 Dec 2026 (estimated)

Resources

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
Prospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04613791
Sponsor's protocol ID
NIMAO/2019-2/FB-01
Acronym
ADOB
Status last verified
Jun 2026
First submitted
28 Oct 2020
Last updated
16 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Centre Hospitalier Universitaire de Nīmes 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 0 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emma LUCQUIAUD, Dr. (+33 4.66.68.33.21, emma.lucquiaud@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire. (time frame: Day 0). The study lists 6 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 16 Jun 2026.

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