Clinical trial NCT06194175: Alcohol Consumption After Bariatric Surgery
Official title: Evolution of Alcohol Consumption Patterns After Bariatric Surgery and Associated Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery
Obesity
Alcohol Drinking
Keywords: bariatric surgery
obesity
alcohol
predictor
longitudinal
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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).

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Alcohol consumption and alcohol use disorder
timeFrame: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.
measure: Binge drinking
timeFrame: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.
measure: Alcohol Intoxication
timeFrame: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.
measure: Antecedents of alcohol use problems
timeFrame: Before surgery only.
measure: Drinking Motives
timeFrame: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.
measure: Sensitivity to alcohol
timeFrame: At 6 months and one year after surgery.
Secondary outcomes:
measure: Binge eating
timeFrame: Before bariatric surgery and one and two years post-surgery.
measure: Emotional eating
timeFrame: Before bariatric surgery and one and two years post-surgery.
measure: Grazing
timeFrame: Before bariatric surgery and one and two years post-surgery.
measure: Emotion regulation
timeFrame: Before bariatric surgery and one and two years post-surgery.
measure: Experiential Avoidance
timeFrame: Before bariatric surgery and one and two years post-surgery.
measure: Impulsivity
timeFrame: Before bariatric surgery and one year post-surgery.
measure: Anxiety
timeFrame: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.
measure: Depression
timeFrame: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.
Other outcomes:
measure: Sociodemographic data
timeFrame: 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.
measure: Type of surgery
timeFrame: Before surgery only.
measure: Weight
timeFrame: Before bariatric surgery and 6 months, one year, one and a half years and two years after surgery.
measure: Height
timeFrame: Before surgery only.
Locations:
city: Auderghem
country: Belgium
facility: Centre Hospitalier Interrégional Edith Cavell - site Delta
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Namur
country: Belgium
facility: Centre Hospitalier Universitaire CHU UCL Namur - site Sainte-Elisabeth
Study officials:
affiliation: University of Liège (Research Unit for a life-Course perspective on Health & Education)
name: ER Esin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: sciensano.be [Online]. Numbers ; [cited 2 déc 2023]. Available : https://www.sciensano.be/en/health-topics/obesity/numbers
citation: 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.
citation: 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.