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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 (ADOB)

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ClinicalTrials.gov Identifier: NCT04613791
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief 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. 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.


Condition or disease Intervention/treatment
Obesity Biological: Blood test

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Situation and Evolution of the Misuse of Alcohol and Other Addictive Behaviors in Obese Patients Being Managed at Nîmes University Hospital
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Blood test
    Collection of epidemio-clinical, biological, radiological and therapeutic patient data
    Other Name: Distribution of the following questionnaires: AUDIT, CAST, HADS, BES, Fagerstrom test and the EQVOD scale


Primary Outcome Measures :
  1. 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 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.

  2. Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire. [ Time Frame: Month 12 ]
    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.

  3. Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire. [ Time Frame: Month 24 ]
    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.

  4. Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire [ Time Frame: Day 0 ]
    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.

  5. Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire [ Time Frame: Month 12 ]
    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.

  6. Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire [ Time Frame: Month 24 ]
    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.


Secondary Outcome Measures :
  1. Smoking (tobacco addiction) according to the Fagerström test [ Time Frame: Day 0 ]
    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.

  2. Smoking (tobacco addiction) according to the Fagerström test [ Time Frame: Month 12 ]
    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.

  3. Smoking (tobacco addiction) according to the Fagerström test [ Time Frame: Month 24 ]
    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.

  4. Cannabis addiction [ Time Frame: Day 0 ]
    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.

  5. Cannabis addiction [ Time Frame: Month 12 ]
    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.

  6. Cannabis addiction [ Time Frame: Month 24 ]
    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.

  7. Use of cocaine [ Time Frame: Day 0 ]
    The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No

  8. Use of cocaine [ Time Frame: Month 12 ]
    The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No

  9. Use of cocaine [ Time Frame: Month 24 ]
    The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No

  10. Use of amphetamines [ Time Frame: Day 0 ]
    The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No

  11. Use of amphetamines [ Time Frame: Month 12 ]
    The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No

  12. Use of amphetamines [ Time Frame: Month 24 ]
    The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No

  13. Use of opioids [ Time Frame: Day 0 ]
    The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No

  14. Use of opioids [ Time Frame: Month 12 ]
    The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No

  15. Use of opioids [ Time Frame: Month 24 ]
    The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No

  16. Use of hallucinogenic drugs and/or new synthetic drugs [ Time Frame: Day 0 ]
    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

  17. Use of hallucinogenic drugs and/or new synthetic drugs [ Time Frame: Month 12 ]
    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

  18. Use of hallucinogenic drugs and/or new synthetic drugs [ Time Frame: Month 24 ]
    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

  19. Eating disorders [ Time Frame: Day 0 ]
    A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.

  20. Eating disorders [ Time Frame: Month 12 ]
    A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.

  21. Eating disorders [ Time Frame: Month 24 ]
    A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.

  22. Comorbidities [ Time Frame: Day 0 ]
    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.

  23. Comorbidities [ Time Frame: Month 12 ]
    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.

  24. Comorbidities [ Time Frame: Month 24 ]
    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.

  25. Quality of Life according to the EQVOD scale [ Time Frame: Day 0 ]
    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.

  26. Quality of Life according to the EQVOD scale [ Time Frame: Month 12 ]
    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.

  27. Quality of Life according to the EQVOD scale [ Time Frame: Month 24 ]
    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.

  28. Anxiety and Depression [ Time Frame: Day 0 ]

    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.


  29. Anxiety and Depression [ Time Frame: Month 12 ]

    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.


  30. Anxiety and Depression [ Time Frame: Month 24 ]

    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.


  31. Binge eating [ Time Frame: Day 0 ]
    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).

  32. Binge eating [ Time Frame: Month 12 ]
    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).

  33. Binge eating [ Time Frame: Month 24 ]
    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).


Other Outcome Measures:
  1. Age [ Time Frame: Day 0 ]
    Age will be recorded in years

  2. Age [ Time Frame: Month 12 ]
    Age will be recorded in years

  3. Age [ Time Frame: Month 24 ]
    Age will be recorded in years

  4. Weight [ Time Frame: Day 0 ]
    Weight will be recorded in kg.

  5. Weight [ Time Frame: Month 12 ]
    Weight will be recorded in kg.

  6. Weight [ Time Frame: Month 24 ]
    Weight will be recorded in kg.

  7. Height [ Time Frame: Day 0 ]
    Height will be recorded in cm

  8. Height [ Time Frame: Month 12 ]
    Height will be recorded in cm

  9. Height [ Time Frame: Month 24 ]
    Height will be recorded in cm

  10. Sex [ Time Frame: Day 0 ]
    Male/Female

  11. Sex [ Time Frame: Month 12 ]
    Male/Female

  12. Sex [ Time Frame: Month 24 ]
    Male/Female

  13. Other relevant items [ Time Frame: Day 0 ]
    All items (X-rays, biological tests, medicinal treatment…) relevant to the patient's care will be noted

  14. Other relevant items [ Time Frame: Month 12 ]
    All items (X-rays, biological tests, medicinal treatment…) relevant to the patient's care will be noted

  15. Other relevant items [ Time Frame: Month 24 ]
    All items (X-rays, biological tests, medicinal treatment…) relevant to the patient's care will be noted


Biospecimen Retention:   Samples Without DNA
Two EDTA tubes of 5ml of blood will be collected for plasma extraction and conservation at -80°C in the biobank (samples taken at the same time as normal blood tests) .Samples will be stored in the hospital's bloodbank (biological resource centre) for the requirements of the future research programs or in view of giving them to other organisations for them to use for research. In order to be conformant with regulations, the samples collected will be subjected to a declaration and request for authorization with the authorities (Ministry of Further Education and Research and the Regional Health Agency) at the end of the trial.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).

Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613791


Contacts
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Contact: Emma LUCQUIAUD, Dr. +33 4.66.68.33.21 emma.lucquiaud@chu-nimes.fr
Contact: Anissa MEGZARI +33 4.66.68.42.36 drc@chu-nimes.fr

Locations
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France
CHU de Nimes Recruiting
Nîmes, France
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Emma LUCQUIAUD, Dr.         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04613791    
Other Study ID Numbers: NIMAO/2019-2/FB-01
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior