Team Science (The Liver Health Study)

NCT06924281 | Completed Results

• 2 other identifiers: 00000611P20GM130414-06S1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Metabolism and alcohol-associated liver disease; Motivational interviewing; Personalized feedback

Outcome Measures

Primary Outcomes (3)

• Proportion Screened With Alcohol Intake and Weight-related Risks for Metabolism and Alcohol-associated Liver Disease

  The primary feasibility outcome is the proportion screened who have alcohol intake and weight-related risks for metabolism and alcohol-associated liver disease. Alcohol intake risk is identified by the 3-item Alcohol Use Disorder Identification Test-Consumption subscale (AUDIT-C). Weight-related risk is identified by body mass index, calculated from weight and height.

  Screening

• Proportion Eligible and Invited to Participate Who Agree to Noninvasive Liver Imaging With Fibroscan® and Arrive for Scheduled Baseline Appointment

  Baseline

• Satisfaction With Fibroscan® Liver Imaging

  Satisfaction with liver screening is assessed with a single-item visual analog scale with 0 indicating low satisfaction and 100 indicating high satisfaction.

  Baseline

Secondary Outcomes (1)

• Alcohol Intake Assessed by Timeline Followback Interview Before and After Intervention

  30 days prior to intervention and 30 days after intervention

Study Arms (2)

Standard Intervention

ACTIVE COMPARATOR

Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing with standard health information.

Behavioral: Brief motivational interviewing with standard health information

Enhanced Intervention

EXPERIMENTAL

Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing that incorporates personalized feedback on self-reported alcohol intake and two scores from Fibroscan® liver imaging that indicate steatosis (liver fat) and fibrosis (liver scaring).

Behavioral: Brief motivational interviewing with personalized feedback

Interventions

Brief motivational interviewing with personalized feedback BEHAVIORAL

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.

Enhanced Intervention

Brief motivational interviewing with standard health information BEHAVIORAL

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.

Standard Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 21 years of age.
• Exceed alcohol intake screening guidelines for MetALD.
• Have a Body Mass Index (BMI) \>=25 kg/m2.
• Be able to speak and read English or Spanish to provide written informed consent and understand written and oral instructions in English or Spanish.

You may not qualify if:

• Pre-existing liver disease or hepatocellular carcinoma or prior liver transplant.
• Pre-existing medical conditions that, in the opinion of the investigative team, would interfere with research participation (e.g., loss of kidney function, uncontrolled infections, multiorgan failure, uncontrolled upper gastrointestinal bleeding, other active malignancies except skin cancer).
• Pre-existing mental health conditions that, in the opinion of the investigative team, would interfere with the ability to provide informed consent and understand written and oral instructions (e.g., hepatic encephalopathy, psychotic disorder diagnosis or symptoms).
• Current pregnancy.
• Be anyone who, based on self-reported withdrawal symptoms and the opinion of the investigative team, could not currently safely be withdrawn from alcohol without medical detoxification.
• Currently receiving formalized psychosocial treatment for an alcohol use or drug problem and/or newly taking medications for an alcohol use or drug problem.
• Currently receiving formalized behavioral weight management treatment and/or newly taking weight loss medications.

Sponsors & Collaborators

• Brown University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Clinica Esperanza Hope Clinic

Providence, Rhode Island, 02909, United States

Location

Results Point of Contact

• Title: Associate Director of Team Science
• Organization: Center for Addiction and Disease Risk Exacerbation

liverhealth@brown.edu

4018636623

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start: April 25, 2025
• Primary Completion: August 29, 2025
• Study Completion: August 31, 2025
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)