Reducing Alcohol Use Post-Bariatric Surgery

NCT ID: NCT04788316

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2025-02-17

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.

Conditions

Bariatric Surgery Candidate; Alcohol Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

CBI and Text messaging

Intervention Type: BEHAVIORAL

A computerized brief intervention (2 sessions) followed by six months of personalized text messaging

Control

Treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CBI and Text messaging

A computerized brief intervention (2 sessions) followed by six months of personalized text messaging

Intervention Type: BEHAVIORAL

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Lisa Matero

Assistant Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Health

Detroit, Michigan, United States

Countries

United States

Other Identifiers

R34AA027775

Identifier Type: NIH

Identifier Source: secondary_id

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RAPS

Identifier Type: -

Identifier Source: org_study_id