Reducing Alcohol Use Post-Bariatric Surgery

A Technology-based Intervention to Reduce Alcohol Use After Bariatric Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking; Bariatric Surgery Candidate
• Intervention / Treatment: Behavioral: CBI and Text messaging

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Matero, PhD; Phone Number: 313-874-5454; Email: lmatero1@hfhs.org
• Study Contact Backup: Name: Jordan Braciszewski, PhD; Phone Number: 313-874-5454; Email: jbracis1@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health
      • Contact: Lisa Matero, PhD; Phone Number: 313-214-8240; Email: lmatero1@hfhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Treatment as usual
Experimental: Intervention; A computerized brief intervention (CBI) followed by six months of personalized text messaging	Behavioral: CBI and Text messaging; A computerized brief intervention (2 sessions) followed by six months of personalized text messaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risky alcohol use	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)	6 months post-baseline
Hazardous alcohol use	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.	6 months post-baseline
Importance of and confidence in the ability to abstain from alcohol	Measured on 0-10 scales; with higher scores indicating greater importance and confidence	6 months post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinking Motives	The Drinking Motives Questionnaire-Revised (DMQ-R) assesses respondents' reasons for drinking across four categories: conformity, coping, enhancement, and social. Each subscale has scores that range from 5-25, with higher scores indicating greater motivation to use alcohol.	6 months post-baseline
Depression	Patient Health Questionnaire depression scale (PHQ-8) will measure depression scores. Scores range from 0-24 with higher scores indicating greater levels of depression.	6 months post-baseline
Anxiety	Measured by the Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0-21 with higher scores indicating greater levels of anxiety.	6 months post-baseline
Food addiction	Yale Food Addiction Scale 2.0 (YFAS 2.0) will assess for symptoms of food addiction (similar to substance use disorder criteria in the DSM-V). Responses result in a symptom count that can range from 0-11 symptoms, with a higher number indicating more symptoms of food addiction. The scale can also indicate whether the symptoms are clinically significant (i.e., yes or no), and the scale can also give a determination of whether someone meets criteria for food addiction (yes or no), and if so, will determine if the addiction is considered mild, moderate, or severe.	Baseline and 1, 3, and 9 month follow ups

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: RAPS; R34AA027775 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No