NCT06194175

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

January 8, 2024

Status Verified

December 1, 2023

Enrollment Period

2.8 years

First QC Date

December 2, 2023

Last Update Submit

December 21, 2023

Conditions

Keywords

bariatric surgeryobesityalcoholpredictorlongitudinal

Outcome Measures

Primary Outcomes (6)

  • 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.

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

  • Binge drinking

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

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

  • Alcohol Intoxication

    Frequency of alcohol intoxication assessed by a single item.

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

  • 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.

    Before surgery only.

  • 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.

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

  • Sensitivity to alcohol

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

    At 6 months and one year after surgery.

Secondary Outcomes (8)

  • Binge eating

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

  • Emotional eating

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

  • Grazing

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

  • Emotion regulation

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

  • Experiential Avoidance

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

  • +3 more secondary outcomes

Other Outcomes (4)

  • Sociodemographic data

    These questions are only asked at baseline, before bariatric surgery. They will be used to provide the description of the participant's characteristics and to control their effects while conducting some statistical analyses.

  • Type of surgery

    Before surgery only.

  • Weight

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

  • +1 more other outcomes

Study Arms (1)

Patients undergoing bariatric surgery

350 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.

Procedure: Bariatric surgery

Interventions

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.

Patients undergoing bariatric surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Hospitalier Interrégional Edith Cavell - site Delta

Auderghem, 1160, Belgium

RECRUITING

Grand Hôpital de Charleroi

Charleroi, 6000, Belgium

RECRUITING

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

RECRUITING

Centre Hospitalier Universitaire CHU UCL Namur - site Sainte-Elisabeth

Namur, 5000, Belgium

RECRUITING

Related Publications (9)

  • 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.

    PMID: 32870301BACKGROUND
  • 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.

    PMID: 25258356BACKGROUND
  • 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.

    PMID: 30350107BACKGROUND
  • 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.

    PMID: 31410716BACKGROUND
  • 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.

    PMID: 28528115BACKGROUND
  • 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.

    PMID: 22710289BACKGROUND
  • sciensano.be [Online]. Numbers ; [cited 2 déc 2023]. Available : https://www.sciensano.be/en/health-topics/obesity/numbers

    BACKGROUND
  • 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.

    PMID: 26241357BACKGROUND
  • 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.

    PMID: 25586736BACKGROUND

MeSH Terms

Conditions

ObesityAlcohol Drinking

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • ER Esin

    University of Liège (Research Unit for a life-Course perspective on Health & Education)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2023

First Posted

January 8, 2024

Study Start

May 30, 2023

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

January 8, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations