Reducing Alcohol Use Post-Bariatric Surgery

Study Overview
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Brief Summary
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Despite bariatric surgery being the most effective weight loss intervention for patients who are severely obese, as many as 1 in 5 patients will develop an alcohol use disorder after their surgery. Changes in metabolism, hormone levels, and behavior as a result of bariatric surgery alter the rewarding effects of alcohol while concurrently changing its absorption rate, putting patients at significantly elevated risk of hazardous drinking. Simply providing education to this vulnerable patient population about post-surgical risks has not been sufficient to reduce alcohol use, yet comprehensive in-person interventions are met with significant challenges, including hours-long distances between patients and their bariatric surgery programs. Thus, the long-term goal is to increase access to an empirically-supported intervention for reducing alcohol use among patients who undergo bariatric surgery by leveraging technology. This intervention, rooted in motivational interviewing and the transtheoretical model, is a two-session computerized brief intervention CBI, supplemented by six months of tailored text messaging based on participants CBI results and subsequent fluctuations in their readiness to change. The purpose of the proposed study is to optimize this technology-based intervention for patients who undergo bariatric surgery and to examine feasibility and acceptability of the intervention. In the first phase, patient interviews will be utilized to identify preferences for intervention content and treatment delivery. Ten patients will then participate in an open trial of the intervention, which will be subsequently revised based on feedback from these patients. In Phase 2, patients will be recruited between 3 and 6 months following bariatric surgery and randomized to the intervention or treatment as usual control group. All patients will complete baseline questionnaires and at 1, 3, 6, and 9 month post-assessments. The investigators expect that this intervention will be both feasible and acceptable to patients. Results will be used as preliminary data to inform a large, fully-powered clinical trial to test the larger efficacy of this intervention.

Official Title
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A Technology-based Intervention to Reduce Alcohol Use After Bariatric Surgery

Conditions
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Bariatric Surgery Candidate, Alcohol Drinking

Intervention / Treatment
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* Behavioral: CBI and Text messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Underwent a bariatric surgery procedure between 3 and 6 months prior to the recruitment date Has not consumed alcohol since undergoing bariatric surgery Exclusion Criteria: History of an alcohol use disorder Never consumed alcohol prior to surgery Does not have a cellular phone that can receive and send text messages No access to internet to complete the computerized brief intervention (CBI)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>A computerized brief intervention (CBI) followed by six months of personalized text messaging | Behavioral: CBI and Text messaging<br>* A computerized brief intervention (2 sessions) followed by six months of personalized text messaging<br>|
| No Intervention: Control<br>Treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to alcohol use | The number of days that elapsed from surgery until the first alcoholic drink | 6 months post-baseline | 
| Number of drinking days | The number of drinking days/days abstinent | 6 months post-baseline | 
| Drinks per day | Average drinks per sitting | 6 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risky alcohol use | Definition of at-risk drinking from the National Institute of on Alcohol Abuse and Alcoholism (i.e., more than 3 drinks in a day for women or 4 for men or more than 7 drinks in a week for women or 14 drinks for men) | 6 months post-baseline | 
| Hazardous alcohol use | Scores on Alcohol Use Disorder Identification Test-Concise. Scores range from 0-12, with higher scores indicating greater potential for hazardous use. Scores of 3+ for women or 4+ for men indicate hazardous use. | 6 months post-baseline | 
| Importance of and confidence in the ability to abstain from alcohol | Measured on 0-10 scales; with higher scores indicating greater importance and confidence | 6 months post-baseline |