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CompletedNCT06924281

Team Science (The Liver Health Study)

Team Science to Identify & Intervene on Metabolism- & Alcohol-Associated Liver Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Brown University · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

Liver damage from alcohol intake and weight-related behaviors is preventable and treatable only through lifestyle changes. This mixed-methods randomized controlled trial compares standard and enhanced approaches to screening, brief intervention, and referral to treatment/prevention (SBIRT/P) to identify and intervene for metabolism- and alcohol-associated liver disease (MetALD). Our multidisciplinary team aims to show that integrating results of noninvasive liver screening with Fibroscan®, a painless ultrasound that measures stiffness and fat in the liver, can optimize our brief intervention. The study population is adults age 21+ who speak Spanish or English from underresourced communities with alcohol- and weight-related risks for MetALD.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBrief motivational interviewing with personalized feedbackThe manualized intervention is delivered individually in two phases by an interventionist trained in motivational interviewing. The intervention includes liver health information and explains connections with weight-related behaviors. The enhanced (experimental) group receives personalized feedback, i.e., a summary of self-reported drinking patterns and results of liver imaging with Fibroscan®, i.e., steatosis (liver fat) and fibrosis (liver scaring) scores. The feedback is used to develop discrepancies between a goal of halting or reversing health risks associated with consuming alcohol versus continuing to drink. The sessions are matched in duration and interventionist skill level with the standard (control) group.
BEHAVIORALBrief motivational interviewing with standard health informationThe manualized intervention is delivered individually in two phases by an interventionist trained in motivational interviewing. The intervention includes liver health information and explains connections with weight-related behaviors. The standard (control) group does not receive personalized feedback. The sessions are matched in duration and interventionist skill level with the enhanced (experimental) group.

Timeline

Start date
2025-04-25
Primary completion
2025-08-29
Completion
2025-08-31
First posted
2025-04-11
Last updated
2026-02-04
Results posted
2026-02-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06924281. Inclusion in this directory is not an endorsement.