Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788316
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-15
First Post:
2021-03-03
Brief Title:
Reducing Alcohol Use Post-Bariatric Surgery
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
A Technology-based Intervention to Reduce Alcohol Use After Bariatric Surgery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34AA027775 | NIH | None | httpsreporternihgovquickSearchR34AA027775 |