A Large Language Model-based Chatbot for Alcohol Reduction in Patients With Metabolic Alcohol-Related Liver Disease

NCT07450144 | Recruiting DMC

• 1 other identifier: MetALD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To assess how many MetALD patients accept the invitation to participate in the trial
2. 2.To assess the retention rate of the participants through 3 and 6 months after treatment initiation
3. 3.To assess the acceptability of the LLM-based chatbot in terms of participants' compliance and usability rating
4. 4.To estimate the intervention effect on alcohol reduction
5. 5.To explore the participants' perception and experiences in the chatbot

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease; Metabolic Alcohol-Related Liver Disease

Keywords

drinking; Chinese; mHealth; WhatsApp; BCTs; COM-B model; cirrhosis; Large language model; AI-based chatbot

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Number of participants divided by the number of eligible subjects

  Through recruitment completion, about 12 months

• Retention rate

  Number of participants completed the follow-up divided by the number of participants

  6 months after randomisation

• Weekly alcohol consumption

  Assessed by questions 1 and 2 of AUDIT-C

  3 months after randomisation

Secondary Outcomes (10)

• Eligibility rate

  Through recruitment completion, about 12 months

• Weekly alcohol consumption

  6 months after randomisation

• Frequency of binge drinking in the past 30 days

  3 months after randomisation

• Frequency of binge drinking in the past 30 days

  6 months after randomisation

• Frequency of heavy drinking in the past 30 days

  3 months after randomisation

Study Arms (2)

LLM-based chatbot

EXPERIMENTAL

LLM-based chatbot + Alcohol Brief Intervention

Behavioral: LLM-based chatbot; Behavioral: Alcohol Brief Intervention

Telephone counseling

ACTIVE COMPARATOR

Telephone counseling + Alcohol Brief Intervention

Behavioral: Telephone counseling; Behavioral: Alcohol Brief Intervention

Interventions

LLM-based chatbot BEHAVIORAL

Over 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.

LLM-based chatbot

Telephone counseling BEHAVIORAL

Over 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.

Telephone counseling

Alcohol Brief Intervention BEHAVIORAL

Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet

LLM-based chatbot; Telephone counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Hong Kong residents aged 18 years or above 2. Diagnosed of MASLD:
• 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
• Presence of metabolic dysfunction, indicated by at least one of the following:
• 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

You may not qualify if:

• Diagnosed with mental disease or cognitive impairments, or
• Participating in other ongoing clinic trials

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Hong Kong Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Fibrosis

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): May 22, 2027
• Study Completion (Estimated): July 22, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

HK (1)