Reducing Alcohol Use Post-Bariatric Surgery

NCT04788316 | Completed

• 2 other identifiers: RAPSR34AA027775
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Risky alcohol use

  6 months post-baseline

• Hazardous alcohol use

  6 months post-baseline

• Importance of and confidence in the ability to abstain from alcohol

  6 months post-baseline

Other Outcomes (4)

• Drinking Motives

  6 months post-baseline

• Depression

  6 months post-baseline

• Anxiety

  6 months post-baseline

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: CBI and Text messaging

Control

NO INTERVENTION

Treatment as usual

Interventions

CBI and Text messaging BEHAVIORAL

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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent a bariatric surgery procedure between 3 and 6 months prior to the recruitment date
• Has not consumed alcohol since undergoing bariatric surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Henry Ford Health System: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• Miller-Matero LR, Pappas C, Christopher B, Grossi R, Vanderziel A, Barnett NP, Moore RS, Bendit S, Hamann A, Carlin AM, Varban OA, Braciszewski JM. A Need for Strategies to Reduce Alcohol Use After Metabolic and Bariatric Surgery: Technology-Based Intervention and Study Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 7;15:e80068. doi: 10.2196/80068.

  PMID: 41499161 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Scientist

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 9, 2021
• Study Start: March 23, 2023
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)