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Completed

NCT Number: NCT06924281

Team Science (The Liver Health Study)

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.

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Key information

Conditions

Steatotic Liver Disease of Mixed Origin (MetALD)

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Esperanza Hope Clinic

Providence, Rhode Island, 02909, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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based on self-reported withdrawal symptoms and the opinion of the investigative team, could not currently safely be withdrawn from alcohol without medical detoxification.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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: Baseline

  3. Satisfaction With Fibroscan® Liver Imaging

    Time frame: Baseline

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

Secondary outcomes

  1. Alcohol Intake Assessed by Timeline Followback Interview Before and After Intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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