Team Science to Identify & Intervene on Metabolism- & Alcohol-Associated Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Proportion Screened With Alcohol Intake and Weight-related Risks for Metabolism and Alcohol-associated Liver Disease
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 21 years of age.
- •Exceed alcohol intake screening guidelines for MetALD.
- •Have a Body Mass Index (BMI) >=25 kg/m
- •Be able to speak and read English or Spanish to provide written informed consent and understand written and oral instructions in English or Spanish.
排除标准
- •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based on self-reported withdrawal symptoms and the opinion of the investigative team, could not currently safely be withdrawn from alcohol without medical detoxification.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.
研究组 & 干预措施
Standard Intervention
Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing with standard health information.
干预措施: Brief motivational interviewing with standard health information (Behavioral)
Enhanced Intervention
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).
干预措施: Brief motivational interviewing with personalized feedback (Behavioral)
结局指标
主要结局
Proportion Screened With Alcohol Intake and Weight-related Risks for Metabolism and Alcohol-associated Liver Disease
时间窗: 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.
Proportion Eligible and Invited to Participate Who Agree to Noninvasive Liver Imaging With Fibroscan® and Arrive for Scheduled Baseline Appointment
时间窗: Baseline
Satisfaction With Fibroscan® Liver Imaging
时间窗: Baseline
Satisfaction with liver screening is assessed with a single-item visual analog scale with 0 indicating low satisfaction and 100 indicating high satisfaction.
次要结局
- Alcohol Intake Assessed by Timeline Followback Interview Before and After Intervention(30 days prior to intervention and 30 days after intervention)