Team Science (The Liver Health Study)

Not Applicable

Recruiting

• Conditions: Steatotic Liver Disease of Mixed Origin (MetALD)

• Registration Number: NCT06924281
• Lead Sponsor: Brown University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-10
• Study First Posted: 2025-04-11
• Study Start: 2025-04-25
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	Baseline	Satisfaction with liver screening is assessed with a single-item visual analog scale with 0 indicating low satisfaction and 100 indicating high satisfaction.
Proportion Screened with Alcohol Intake and Weight-related Risks for Metabolism and Alcohol-associated Liver Disease	Screening	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.

Secondary Outcome Measures

Name	Time	Method
Alcohol Intake Assessed by Timeline Followback Interview Before and After Intervention	30 days prior to intervention and 30 days after intervention	Timeline followback interviews will be individually administered in a semi-structured format by outcomes assessors who are masked to intervention condition. Interviews follow standardized procedures using a 30-day calendar to identify anchoring events, abstinent days, and types of alcohol consumed including ounces and alcohol by volume.

Trial Locations

Locations (1)

Clinica Esperanza Hope Clinic; 🇺🇸 Providence, Rhode Island, United States