Clinical trial NCT04788316: Reducing Alcohol Use Post-Bariatric Surgery
Official title: A Technology-based Intervention to Reduce Alcohol Use After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Alcohol Drinking
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-03-09
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Time to alcohol use
timeFrame: 6 months post-baseline
measure: Number of drinking days
timeFrame: 6 months post-baseline
measure: Drinks per day
timeFrame: 6 months post-baseline
Secondary outcomes:
measure: Risky alcohol use
timeFrame: 6 months post-baseline
measure: Hazardous alcohol use
timeFrame: 6 months post-baseline
measure: Importance of and confidence in the ability to abstain from alcohol
timeFrame: 6 months post-baseline
Other outcomes:
measure: Drinking Motives
timeFrame: 6 months post-baseline
measure: Depression
timeFrame: 6 months post-baseline
measure: Anxiety
timeFrame: 6 months post-baseline
measure: Food addiction
timeFrame: Baseline and 1, 3, and 9 month follow ups
Locations:
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
Study officials:
References: