Team Science (The Liver Health Study)

Brown University

Status: Completed

Conditions: Steatotic Liver Disease of Mixed Origin (MetALD)

Treatments: Behavioral: Brief motivational interviewing with personalized feedback; Behavioral: Brief motivational interviewing with standard health information

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06924281

P20GM130414-06S1 (U.S. NIH Grant/Contract)

00000611

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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based on self-reported withdrawal symptoms and the opinion of the investigative team, could not currently safely be withdrawn from alcohol without medical detoxification.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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Standard Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Brief motivational interviewing with standard health information

Enhanced Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Brief motivational interviewing with personalized feedback