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Reducing Alcohol Use Post-Bariatric Surgery
NCT04788316 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- BEHAVIORAL CBI and Text messaging
Study Locations (1)
Michigan
- Henry Ford Health — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-03-23 |
| Est. Completion | 2025-02-17 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04788316
The ClinicalTrials.gov registry entry for NCT04788316 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 171 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Alcohol Drinking appearing as the primary indexed condition, and to 1 intervention — of which CBI and Text messaging is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04788316 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04788316 about?
NCT04788316 is a clinical study titled "Reducing Alcohol Use Post-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 rewardi...
What is the current status of trial NCT04788316?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2023-03-23. Estimated completion is 2025-02-17.
What conditions does trial NCT04788316 study?
This clinical trial studies the following conditions: Alcohol Drinking, Bariatric Surgery Candidate. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04788316?
The interventions under investigation include: CBI and Text messaging (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04788316?
This trial is sponsored by Henry Ford Health System, which has 171 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04788316 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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