Bariatric Surgery CandidateNCT04788316
Reducing Alcohol Use Post-Bariatric Surgery
A study testing CBI and Text messaging in people with Bariatric Surgery Candidate and Alcohol Drinking, run by Henry Ford Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bariatric Surgery Candidate, Alcohol Drinking
- What is being tested?
- CBI and Text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2023to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Underwent a bariatric surgery procedure between 3 and 6 months prior to the recruitment date
- Has not consumed alcohol since undergoing bariatric surgery
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bariatric Surgery Candidate, Alcohol Drinking
- Being tested
- CBI and Text messaging
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBI and Text messagingBehavioural
A computerized brief intervention (2 sessions) followed by six months of personalized text messaging
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A computerized brief intervention (CBI) followed by six months of personalized text messaging Receives: Behavioral: CBI and Text messaging |
| Control | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to alcohol use
The number of days that elapsed from surgery until the first alcoholic drink
Measured: 6 months post-baseline
Number of drinking days
The number of drinking days/days abstinent
Measured: 6 months post-baseline
Drinks per day
Average drinks per sitting
Measured: 6 months post-baseline
Secondary outcomes (3)
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)
Measured: 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.
Measured: 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
Measured: 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start23 Mar 2023
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Lisa Matero, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788316
- Sponsor's protocol ID
- RAPS
- Other IDs
- R34AA027775
- Status last verified
- May 2025
- First submitted
- 3 Mar 2021
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41499161
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-based Intervention to Reduce Alcohol Use After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04788316
- Acronym / sponsor ID
- RAPS
- Conditions
- Bariatric Surgery Candidate, Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: CBI and Text messagingA computerized brief intervention (CBI) followed by six months of personalized text messaging |
| Control | No intervention | –Treatment as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Underwent a bariatric surgery procedure between 3 and 6 months prior to the recruitment date
- Has not consumed alcohol since undergoing bariatric surgery
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBI and Text messagingA computerized brief intervention (2 sessions) followed by six months of personalized text messaging | Behavioural | Intervention |
Primary outcome
Time to alcohol use
Time frame: 6 months post-baseline
The number of days that elapsed from surgery until the first alcoholic drink
Number of drinking days
Time frame: 6 months post-baseline
The number of drinking days/days abstinent
Drinks per day
Time frame: 6 months post-baseline
Average drinks per sitting
3 secondary outcomes
Risky alcohol use
Time frame: 6 months post-baseline
Hazardous alcohol use
Time frame: 6 months post-baseline
Importance of and confidence in the ability to abstain from alcohol
Time frame: 6 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 41499161Miller-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBI and Text messaging in people with Bariatric Surgery Candidate and Alcohol Drinking, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to alcohol use (time frame: 6 months post-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04788316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.