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Reducing Alcohol Use Post-Bariatric Surgery

Primary Purpose

Bariatric Surgery Candidate, Alcohol Drinking

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBI and Text messaging
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bariatric Surgery Candidate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Henry Ford HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

Treatment as usual

Outcomes

Primary Outcome Measures

Time to alcohol use
The number of days that elapsed from surgery until the first alcoholic drink
Number of drinking days
The number of drinking days/days abstinent
Drinks per day
Average drinks per sitting

Secondary Outcome Measures

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)
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.
Importance of and confidence in the ability to abstain from alcohol
Measured on 0-10 scales; with higher scores indicating greater importance and confidence

Full Information

First Posted
March 3, 2021
Last Updated
June 13, 2023
Sponsor
Henry Ford Health System
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04788316
Brief Title
Reducing Alcohol Use Post-Bariatric Surgery
Official Title
A Technology-based Intervention to Reduce Alcohol Use After Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Alcohol Drinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
A computerized brief intervention (CBI) followed by six months of personalized text messaging
Arm Title
Control
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
CBI and Text messaging
Intervention Description
A computerized brief intervention (2 sessions) followed by six months of personalized text messaging
Primary Outcome Measure Information:
Title
Time to alcohol use
Description
The number of days that elapsed from surgery until the first alcoholic drink
Time Frame
6 months post-baseline
Title
Number of drinking days
Description
The number of drinking days/days abstinent
Time Frame
6 months post-baseline
Title
Drinks per day
Description
Average drinks per sitting
Time Frame
6 months post-baseline
Secondary Outcome Measure Information:
Title
Risky alcohol use
Description
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)
Time Frame
6 months post-baseline
Title
Hazardous alcohol use
Description
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.
Time Frame
6 months post-baseline
Title
Importance of and confidence in the ability to abstain from alcohol
Description
Measured on 0-10 scales; with higher scores indicating greater importance and confidence
Time Frame
6 months post-baseline
Other Pre-specified Outcome Measures:
Title
Drinking Motives
Description
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.
Time Frame
6 months post-baseline
Title
Depression
Description
Patient Health Questionnaire depression scale (PHQ-8) will measure depression scores. Scores range from 0-24 with higher scores indicating greater levels of depression.
Time Frame
6 months post-baseline
Title
Anxiety
Description
Measured by the Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0-21 with higher scores indicating greater levels of anxiety.
Time Frame
6 months post-baseline
Title
Food addiction
Description
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.
Time Frame
Baseline and 1, 3, and 9 month follow ups

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Matero, PhD
Phone
313-874-5454
Email
lmatero1@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Braciszewski, PhD
Phone
313-874-5454
Email
jbracis1@hfhs.org
Facility Information:
Facility Name
Henry Ford Health
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Matero, PhD
Phone
313-214-8240
Email
lmatero1@hfhs.org

12. IPD Sharing Statement

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Reducing Alcohol Use Post-Bariatric Surgery

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