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Team Science (The Liver Health Study)

NCT06924281 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-02-04

Study results available
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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

  • Steatotic Liver Disease of Mixed Origin (MetALD)

Interventions

BEHAVIORAL

Brief motivational interviewing with personalized feedback

The 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.

BEHAVIORAL

Brief motivational interviewing with standard health information

The 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.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Brown University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-25
Primary Completion
2025-08-29
Completion
2025-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06924281 on ClinicalTrials.gov