Reducing Alcohol Use Post-Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788316
• Other study ID #: RAPS
• Secondary ID: R34AA027775
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Henry Ford Health System
• Contact: Lisa Matero, PhD
• Phone: 313-874-5454
• Email: lmatero1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Bariatric Surgery Candidate

Intervention

Behavioral:
• CBI and Text messaging
A computerized brief intervention (2 sessions) followed by six months of personalized text messaging

Locations

Country	Name	City	State
United States	Henry Ford Health	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	Time to alcohol use	The number of days that elapsed from surgery until the first alcoholic drink	6 months post-baseline
Primary	Number of drinking days	The number of drinking days/days abstinent	6 months post-baseline
Primary	Drinks per day	Average drinks per sitting	6 months post-baseline
Secondary	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
Secondary	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
Secondary	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