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NCT Number: NCT07450144

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

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

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Key information

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease Fibrosis Metabolic Alcohol-Related Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Alcohol brief intervention

Behavioral

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

Primary outcomes

  1. Recruitment rate

    Time frame: Through recruitment completion, about 12 months

    Number of participants divided by the number of eligible subjects

  2. Retention rate

    Time frame: 6 months after randomisation

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

  3. Weekly alcohol consumption

    Time frame: 3 months after randomisation

    Assessed by questions 1 and 2 of AUDIT-C

Secondary outcomes

  1. Eligibility rate

    Time frame: Through recruitment completion, about 12 months

    Number of eligible patients divided by the number of patients screened

  2. Weekly alcohol consumption

    Time frame: 6 months after randomisation

    Assessed by questions 1 and 2 of AUDIT-C

  3. Frequency of binge drinking in the past 30 days

    Time frame: 3 months after randomisation

    Self-reported

  4. Frequency of binge drinking in the past 30 days

    Time frame: 6 months after randomisation

    Self-reported

  5. Frequency of heavy drinking in the past 30 days

    Time frame: 3 months after randomisation

    Self-reported

  6. Frequency of heavy drinking in the past 30 days

    Time frame: 6 months after randomisation

    Self-reported

  7. AUDIT score and level

    Time frame: 3 months after randomisation

    Assessed by the Alcohol Use Disorders Identification Test

  8. AUDIT score and level

    Time frame: 6 months after randomisation

    Assessed by the Alcohol Use Disorders Identification Test

  9. Planned drinking in the coming 30 days

    Time frame: 3 months after randomisation

    Self-reported

  10. Planned drinking in the coming 30 days

    Time frame: 6 months after randomisation

    Self-reported

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

A Large Language Model-based Chatbot for Alcohol Reduction Counseling in MetALD Patients: A Pilot Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 23, 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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