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NCT04788316 · ClinicalTrials.gov registry record · NA
Reducing Alcohol Use Post-Bariatric Surgery
A NA study of Alcohol Drinking and Bariatric Surgery Candidate, sponsored by Henry Ford Health System.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04788316: Completed NA study of Alcohol Drinking and Bariatric Surgery Candidate, sponsored by Henry Ford Health System.
NCT04788316 is a NA study of Alcohol Drinking and Bariatric Surgery Candidate that has completed, run by Henry Ford Health System. The registered enrollment target is 60 participants, below the 630-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04788316, a NA study of Alcohol Drinking and Bariatric Surgery Candidate, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
The number of days that elapsed from surgery until the first alcoholic drink
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 |
What the finished NCT04788316 record still lists
NCT04788316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 630-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (90% lower).
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.
NCT04788316 reports a single indexed study location in Michigan.
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.
What interventions are being tested in trial NCT04788316?
The interventions under investigation include: CBI and Text messaging (BEHAVIORAL).
Who is sponsoring clinical trial NCT04788316?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Alcohol Drinking
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04788316's enrollment target sits among peer trials
60 64th of 85 higher than 20 of 85 other Alcohol Drinking trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Drinking trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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