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Bariatric SurgeryNCT06194175

Alcohol Consumption After Bariatric Surgery

An observational study of Bariatric Surgery and Obesity, run by University of Liege at 4 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A large body of studies indicate an increase in alcohol use disorder (AUD) rates after bariatric surgery. However, little information exists on the evolution of other drinking patterns after surgery and the psychological predictors of problematic drinking postoperatively. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bariatric Surgery, Obesity, Alcohol Drinking
What is being tested?
Bariatric surgery
Type of treatment
Surgery or procedure
How many people
350 participants
Where
4 sitesBelgium
Study dates
30 May 2023to 30 Mar 2026
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: Adults (1) suffering from obesity, with a body mass index (BMI) greater than or equal to 40, or a BMI greater than or equal to 35 with at least one obesity-related comorbidity; (2) and whose candidacy for bariatric surgery has been accepted (i.e. who have obtained an operation date).

Who may be able to join

  • Being 18 years or older at the time of surgery
  • Having a body mass index (BMI) greater than or equal to 40 or a BMI greater than or equal to 35 with at least one obesity-related comorbidity
  • Having a scheduled surgery date
  • Fluency in French speaking
  • Being able to complete the questionnaires, i.e. have access to a computer or a smartphone

Who cannot join

  • Being a minor at the time of the operation
  • Having difficulty reading or understanding French.
  • Not having access to a computer or a smartphone to answer the questionnaires

Trial locations and contacts

4 sites in 1 country.

ER Esin contact

+32 471011382

esin.er@doct.uliege.be

Belgium4 sites, 4 recruiting

  • Centre Hospitalier Interrégional Edith Cavell - site Delta

    Auderghem, 1160

    Esin Er, esin.er@doct.uliege.be

    Recruiting

  • Grand Hôpital de Charleroi

    Charleroi, 6000

    Esin Er, esin.er@doct.uliege.be

    Recruiting

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

    Esin Er

    Recruiting

  • Centre Hospitalier Universitaire CHU UCL Namur - site Sainte-Elisabeth

    Namur, 5000

    Esin Er, esin.er@doct.uliege.be

    Recruiting

Other trials in Belgium

About this study

Official title: Evolution of Alcohol Consumption Patterns After Bariatric Surgery and Associated Factors

A large body of studies indicate an increase in alcohol use disorder (AUD) rates after bariatric surgery. However, little information exists on the evolution of other drinking patterns after surgery and the psychological predictors of problematic drinking postoperatively. The identification of these factors is necessary for the implementation of prevention strategies regarding postoperative problematic alcohol use. The aim of this research is to examine the evolution of various drinking patterns after bariatric surgery as well as the psychological factors associated with AUD and an increase in postoperative alcohol consumption.

Read the detailed description

Obesity affects 15.9% of the Belgian population and remains a difficult disease to treat with traditional weight loss interventions. Its high prevalence and the negative consequences it entails make it a public health concern. Bariatric surgery is associated with long-term weight loss and an improvement in obesity-related comorbidities. However, despite its success in achieving significant and lasting weight loss, numerous studies raise the emergence of unpleasant psychosocial problems after the operation, including an increase of regular alcohol consumption and prevalence of AUD. Some of these studies are longitudinal and include large samples. For example, in a prospective multicenter study, King et al., (2017) found that more than 20% of patients with a bariatric surgery present symptoms of AUD within five years after surgery. Moreover, some studies suggest that, among patients with postoperative AUD, some had never suffered from alcohol problems before surgery.

Given the severe negative consequences of AUD for the individuals who suffer from it, their family and the society, better understanding the factors involved in postoperative alcohol use problems is necessary. However, little is known about predictors of post-bariatric surgery AUD. Known risk factors are: male gender, smoking, regular alcohol consumption before surgery, younger age, recreational drug use, lower sense of belonging and ADHD symptoms. Information is lacking about the psychological risk factors for postoperative AUD and regarding the evolution of problematic drinking patterns other than AUD after surgery.

Given the previously cited gaps in the scientific literature, the present research's aims are to study the evolution of different drinking patterns after bariatric surgery as well as the psychological factors associated with AUD and increased alcohol consumption postoperatively.

Being tested
Bariatric surgery
Keywords
bariatric surgery, obesity, alcohol, predictor, longitudinal
Medical subject headings
Obesity, Alcohol Drinking

What participants receive

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

  • Bariatric surgeryProcedure or surgery

    Participants whose application for bariatric surgery was accepted, regardless of the type of surgical intervention (e.g., sleeve gastrectomy, Roux-en-Y Gastric Bypass).

    This longitudinal study includes five measurement times: before surgery and then, 6 months, one year, one and a half years and two years after surgery. At each measurement time, participants are asked to respond to a set of online questionnaires. Responses are anonymous.

Study groups in NCT06194175
Study groupRoleWhat they receive
Patients undergoing bariatric surgery350 adults (1) suffering from obesity, with a body mass index (BMI) greater than or equal to 40, or a BMI greater than or equal to 35 with at least one obesity-related comorbidity; (2) and whose candidacy for bariatric surgery has been accepted (i.e. who have obtained an operation date). Participants are recruited from four hospitals practicing bariatric surgery in Belgium.
Receives: Procedure: Bariatric surgery

What is being measured

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

  1. Alcohol consumption and alcohol use disorder

    Alcohol consumption and presence of alcohol use disorder assessed using the Alcohol Use Disorders Identification Test (AUDIT). Scores on the AUDIT range from 0 to 40, with higher scores indicating more problematic alcohol use.

    Measured: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.

  2. Binge drinking

    Frequency of binge drinking as evaluated by a three item questionnaire.

    Measured: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.

  3. Alcohol Intoxication

    Frequency of alcohol intoxication assessed by a single item.

    Measured: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.

  4. Antecedents of alcohol use problems

    Assessment of the lifetime presence of alcohol problems using the CAGE questionnaire (CAGE as an acronym for "Cut down drinking", "Annoyed by criticism", "Guilty feelings" and "Eye-opener").This questionnaire is made up of 4 items to which participants can respond on a binary scale ("yes" or "no"). Two or more "yes" answers indicate an alcohol abuse problem.

    Measured: Before surgery only.

  5. Drinking Motives

    Assessment of reasons for consuming alcohol using the Drinking Motives Questionnaire - Revised Short Form. This questionnaire is composed of 12 items and 4 subscales assessing four types of motivation to drink. Scores on each of the subscales range from 3 to 9, with higher scores indicating more motivations to drink.

    Measured: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.

  6. Sensitivity to alcohol

    Single-question assessment of the extent to which participants perceive a change in their response to alcohol following bariatric surgery.

    Measured: At 6 months and one year after surgery.

Secondary outcomes (8)

  1. Binge eating

    Assessment of binge eating behaviors using the Binge Eating Scale. Scores on this scale range from 0 to 46, with a higher score indicating a higher levels of binge eating. A score greater than or equal to 18 on this scale indicates binge eating disorder.

    Measured: Before bariatric surgery and one and two years post-surgery.

  2. Emotional eating

    Assessment of emotional eating through the "emotional eating" subscale of the Dutch Eating Behavior Questionnaire. Scores on this subscale range from 13 to 65, with higher scores indicating a greater tendency toward emotional eating.

    Measured: Before bariatric surgery and one and two years post-surgery.

  3. Grazing

    Assessment of grazing behaviors through a single question.

    Measured: Before bariatric surgery and one and two years post-surgery.

  4. Emotion regulation

    Assessment of emotional regulation using the Difficulties in Emotion Regulation Scale. It includes 6 subscales (i.e., nonacceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies and lack of emotional clarity). A total score is calculated as well as scores for each subscale. Higher scores suggest higher levels of emotional regulation deficits.

    Measured: Before bariatric surgery and one and two years post-surgery.

  5. Experiential Avoidance

    Assessment of experiential avoidance using the Brief Experiential Avoidance Questionnaire. Scores on this scale range from 15 to 90, with higher scores indicating higher levels of experiential avoidance.

    Measured: Before bariatric surgery and one and two years post-surgery.

  6. Impulsivity

    Assessment of impulsivity through a short version of the UPPS-P Impulsive Behavior Scale. This scale includes 5 subscales: negative urgency, positive urgency, lack of premeditation, lack of perseverance, and sensation seeking. Higher scores on these subscales indicate higher levels of impulsivity.

    Measured: Before bariatric surgery and one year post-surgery.

  7. Anxiety

    Assessment of anxiety using the "Anxiety" subscale of the Hospital Anxiety and Depression Scale.This subscale has 7 items. Scores vary between 0 and 21. A score greater than or equal to 8 is an indicator of anxiety.

    Measured: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.

  8. Depression

    Assessment of depressive symptoms using the "Depression" subscale of the Hospital Anxiety and Depression Scale.This subscale has 7 items. Scores vary between 0 and 21. A score greater than or equal to 8 is an indicator of depressive symptoms.

    Measured: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.

Timeline

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

  1. First posted8 Jan 2024
  2. Study start30 May 2023
  3. Primary completion30 Mar 2026 (estimated)
  4. Study completion30 Mar 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
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06194175
Sponsor's protocol ID
2023-043 (CHU de Liège)
Status last verified
Dec 2023
First submitted
2 Dec 2023
Last updated
8 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arterburn DE, Telem DA, Kushner RF, Courcoulas AP. Benefits and Risks of Bariatric Surgery in Adults: A Review. JAMA. 2020 Sep 1;324(9):879-887. doi: 10.1001/jama.2020.12567.

    PubMed 32870301

  • Cuellar-Barboza AB, Frye MA, Grothe K, Prieto ML, Schneekloth TD, Loukianova LL, Hall-Flavin DK, Clark MM, Karpyak VM, Miller JD, Abulseoud OA. Change in consumption patterns for treatment-seeking patients with alcohol use disorder post-bariatric surgery. J Psychosom Res. 2015 Mar;78(3):199-204. doi: 10.1016/j.jpsychores.2014.06.019. Epub 2014 Sep 7.

    PubMed 25258356

  • Ibrahim N, Alameddine M, Brennan J, Sessine M, Holliday C, Ghaferi AA. New onset alcohol use disorder following bariatric surgery. Surg Endosc. 2019 Aug;33(8):2521-2530. doi: 10.1007/s00464-018-6545-x. Epub 2018 Oct 22.

    PubMed 30350107

  • Ivezaj V, Benoit SC, Davis J, Engel S, Lloret-Linares C, Mitchell JE, Pepino MY, Rogers AM, Steffen K, Sogg S. Changes in Alcohol Use after Metabolic and Bariatric Surgery: Predictors and Mechanisms. Curr Psychiatry Rep. 2019 Aug 13;21(9):85. doi: 10.1007/s11920-019-1070-8.

    PubMed 31410716

  • King WC, Chen JY, Courcoulas AP, Dakin GF, Engel SG, Flum DR, Hinojosa MW, Kalarchian MA, Mattar SG, Mitchell JE, Pomp A, Pories WJ, Steffen KJ, White GE, Wolfe BM, Yanovski SZ. Alcohol and other substance use after bariatric surgery: prospective evidence from a U.S. multicenter cohort study. Surg Obes Relat Dis. 2017 Aug;13(8):1392-1402. doi: 10.1016/j.soard.2017.03.021. Epub 2017 Mar 31.

    PubMed 28528115

  • King WC, Chen JY, Mitchell JE, Kalarchian MA, Steffen KJ, Engel SG, Courcoulas AP, Pories WJ, Yanovski SZ. Prevalence of alcohol use disorders before and after bariatric surgery. JAMA. 2012 Jun 20;307(23):2516-25. doi: 10.1001/jama.2012.6147.

    PubMed 22710289

  • sciensano.be [Online]. Numbers ; [cited 2 déc 2023]. Available : https://www.sciensano.be/en/health-topics/obesity/numbers

  • Spadola CE, Wagner EF, Dillon FR, Trepka MJ, De La Cruz-Munoz N, Messiah SE. Alcohol and Drug Use Among Postoperative Bariatric Patients: A Systematic Review of the Emerging Research and Its Implications. Alcohol Clin Exp Res. 2015 Sep;39(9):1582-601. doi: 10.1111/acer.12805. Epub 2015 Aug 4.

    PubMed 26241357

  • Wiedemann AA, Saules KK, Ivezaj V. Emergence of New Onset substance use disorders among post-weight loss surgery patients. Clin Obes. 2013 Dec;3(6):194-201. doi: 10.1111/cob.12034. Epub 2013 Oct 15.

    PubMed 25586736

Questions about this trial

What is this clinical trial studying?

An observational study of Bariatric Surgery and Obesity, run by University of Liege at 4 sites in Belgium.

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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. 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?

Results are not available in the source record.

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

Contact ER Esin (+32 471011382, esin.er@doct.uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol consumption and alcohol use disorder (time frame: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.). 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?

On the ClinicalTrials.gov record for NCT06194175, which also lists 9 linked publications.

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 8 Jan 2024.

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