Situation and Evolution of the Misuse of Alcohol and Other Addictive Behaviors in Obese Patients Being Managed at Nîmes University Hospital
ADOB
1 other identifier
observational
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedStudy Start
First participant enrolled
February 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedJanuary 12, 2023
January 1, 2023
2.8 years
October 28, 2020
January 11, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (33)
Smoking (tobacco addiction) according to the Fagerström test
Day 0
Smoking (tobacco addiction) according to the Fagerström test
Month 12
Smoking (tobacco addiction) according to the Fagerström test
Month 24
Cannabis addiction
Day 0
Cannabis addiction
Month 12
- +28 more secondary outcomes
Other Outcomes (25)
Age
Day 0
Age
Month 12
Age
Month 24
- +22 more other outcomes
Interventions
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
Eligibility Criteria
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).
You may not qualify if:
- Patient with psychiatric disorder reducing capacity for comprehension.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nimes
Nîmes, France
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2020
First Posted
November 3, 2020
Study Start
February 16, 2021
Primary Completion
December 15, 2023
Study Completion
December 15, 2023
Last Updated
January 12, 2023
Record last verified: 2023-01