The goal of this pilot randomized controlled trial is to evaluate the trial feasibility and acceptability of LLM-based chatbot for reducing alcohol use among patients with metabolic alcohol-related liver disease. Specific objectives include:
1. To assess how many MetALD patients accept the invitation to participate in the trial 2. To assess the retention rate of the participants through 3 and 6 months after treatment initiation 3. To assess the acceptability of the LLM-based chatbot in terms of participants' compliance and usability rating 4. To estimate the intervention effect on alcohol reduction 5. To explore the participants' perception and experiences in the chatbot
Evidence of hepatic steatosis (fat accumulation in the liver) confirmed by imaging techniques such as ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), or liver biopsy
Overweight or obesity (body mass index [BMI] ≥25 kg/m²),
Type 2 diabetes mellitus, ③Dyslipidemia (elevated triglycerides [≥150 mg/dL] or low high-density lipoprotein [HDL] cholesterol [<40 mg/dL for men, <50 mg/dL for women]), ④Hypertension (blood pressure ≥130/85 mmHg or use of antihypertensive medication).
Metabolic syndrome as defined by established criteria (e.g., International Diabetes Federation [IDF], Adult Treatment Panel III [ATP III]) 3. Alcohol consumption: males who drink 210-420 g/week (≈263-525 ml), female who drink 140-350 g/week (≈175-438 ml) 4. Intention to reduce/quit alcohol 5. Able to read and communicate in Chinese 6. Own a smartphone with internet access
Diagnosed with mental disease or cognitive impairments, or
Participating in other ongoing clinic trials
Parallel
LLM-based chatbot
BehavioralOver the three months following randomisation, an LLM-based chatbot will interact with each participant individually to deliver four personalized sessions of alcohol reduction information and advice, and participants will also be allowed to contact the chatbot at any time.
Telephone counseling
BehavioralOver the three months following randomisation, a trained counsellor will conduct four individual daytime telephone sessions with each participant to provide personalised information and advice on reducing alcohol consumption.
Alcohol Brief Intervention
BehavioralBrief counselling (5 to 10 mins) to reduce drinking and a self-help booklet
Recruitment rate
Number of participants divided by the number of eligible subjects
Retention rate
Number of participants completed the follow-up divided by the number of participants
Weekly alcohol consumption
Assessed by questions 1 and 2 of AUDIT-C
Eligibility rate
Number of eligible patients divided by the number of patients screened
Weekly alcohol consumption
Assessed by questions 1 and 2 of AUDIT-C
Frequency of binge drinking in the past 30 days
Self-reported
Frequency of binge drinking in the past 30 days
Self-reported
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