Reducing Alcohol Use Post-Bariatric Surgery
- Conditions
- Bariatric Surgery CandidateAlcohol Drinking
- Interventions
- Behavioral: CBI and Text messaging
- Registration Number
- NCT04788316
- Lead Sponsor
- Henry Ford Health System
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Underwent a bariatric surgery procedure between 3 and 6 months prior to the recruitment date
- Has not consumed alcohol since undergoing bariatric surgery
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention CBI and Text messaging A computerized brief intervention (CBI) followed by six months of personalized text messaging
- Primary Outcome Measures
Name Time Method Drinks per day 6 months post-baseline Average drinks per sitting
Time to alcohol use 6 months post-baseline The number of days that elapsed from surgery until the first alcoholic drink
Number of drinking days 6 months post-baseline The number of drinking days/days abstinent
- Secondary Outcome Measures
Name Time Method Hazardous alcohol use 6 months post-baseline 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.
Importance of and confidence in the ability to abstain from alcohol 6 months post-baseline Measured on 0-10 scales; with higher scores indicating greater importance and confidence
Risky alcohol use 6 months post-baseline 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)
Trial Locations
- Locations (1)
Henry Ford Health
🇺🇸Detroit, Michigan, United States