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

Study Overview
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Brief Summary
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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. 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.

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

Conditions
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Obesity

Intervention / Treatment
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* Biological: Blood test


Participation Criteria
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Eligibility Criteria
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Patient being managed for the first time at Nîmes University Hospital Obesity Clinic ( complete hospitalization, outpatients' or consultation). Patient being managed for obesity defined by a body mass index (BMI) of 30 kg.m-² or over Patient affiliated to or covered by a health insurance scheme. Adult patient (≥ 18 years). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Blood test|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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0 | 
| 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. | Month 12 | 
| 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. | Month 24 | 
| 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. | Day 0 | 
| 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. | Month 12 | 
| 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. | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0 | 
| 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. | Month 12 | 
| 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. | Month 24 | 
| 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. | Day 0 | 
| 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. | Month 12 | 
| 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. | Month 24 | 
| Use of cocaine | The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No | Day 0 | 
| Use of cocaine | The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No | Month 12 | 
| Use of cocaine | The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No | Month 24 | 
| Use of amphetamines | The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No | Day 0 | 
| Use of amphetamines | The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No | Month 12 | 
| Use of amphetamines | The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No | Month 24 | 
| Use of opioids | The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No | Day 0 | 
| Use of opioids | The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No | Month 12 | 
| Use of opioids | The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No | Month 24 | 
| 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 | Day 0 | 
| 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 | Month 12 | 
| 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 | Month 24 | 
| Eating disorders | A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder. | Day 0 | 
| Eating disorders | A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder. | Month 12 | 
| Eating disorders | A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder. | Month 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. | Day 0 | 
| 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. | Month 12 | 
| 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. | Month 24 | 
| 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. | Day 0 | 
| 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. | Month 12 | 
| 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. | Month 24 | 
| 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. | Day 0 | 
| 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. | Month 12 | 
| 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. | Month 24 | 
| 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). | Day 0 | 
| 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). | Month 12 | 
| 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). | Month 24 |