Reducing Alcohol Use Post-Bariatric Surgery

Henry Ford Health

Status: Completed

Conditions: Bariatric Surgery Candidate; Alcohol Drinking

Treatments: Behavioral: CBI and Text messaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04788316

RAPS

R34AA027775 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Intervention

Experimental group

Description:

A computerized brief intervention (CBI) followed by six months of personalized text messaging

Treatment:

Behavioral: CBI and Text messaging

Control

No Intervention group

Description:

Treatment as usual