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Comparative Efficacy of Large Language Model Assisted Weight Management vs Standard In Person Care in MASLD An Open Label Randomized Controlled Trial

Comparative Efficacy of Large Language Model Assisted Weight Management vs Standard In Person Care in MASLD An Open Label Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260602002
Enrollment
90
Registered
2026-06-02
Start date
2026-05-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MASLD, MASH, Obesity MASLD MASH Obesity Weight Loss AI Chatbot

Interventions

1.The patient LINE application will be connected to the LLM system API at the first physician visit (week 0). At the initial setup, personal information will be entered, including underlying diseases,
LLM Weight Management (LWM),In-person Management standard care (IPM)

Sponsors

The Gastrointestinal association of Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Adults aged 18 to 65 years 2.Diagnosed with MASLD or MASH based on imaging or VCTE according to AASLD/APASL criteria 3.BMI equal or more than 25 kg/m 4.Provide informed consent to participate in the study 5.Able to read, write, and communicate clearly in Thai, and have access to a smartphone or the internet (LWM group)

Exclusion criteria

Exclusion criteria: 1.Other liver diseases, including HBV, HCV, autoimmune liver disease, or significant alcohol consumption, defined as an average intake of >30 g/day in men and >20 g/day in women 2.Cirrhosis or METAVIR F4 fibrosis 3.HCC at any stage 4.Planned initiation of any new weight-loss medication during the study period 5.Severe medical illness or psychiatric disorder that would interfere with study participation 6.Pregnancy or breastfeeding

Design outcomes

Primary

MeasureTime frame
Proportion of participants who achieve more than or equal to 5% weight loss from baseline body weight at 6 months 6 months Weighing

Secondary

MeasureTime frame
Percentage change in body weight over time 2 4 6 months Weighing,Changes in CAP and LSM 6 months VCTE ,Reduction in ALT/AST levels 2 4 6 months Blood test (LFT),Changes in HbA1c, FPG, lipid profile, and blood pressure 2 4 6 months Blood tests,Adherence rate, including LLM usage rate and clinic attendance rate 2 4 6 months Case record form at visit ,Satisfaction 6 months Questionnaire

Countries

Thailand

Contacts

Public ContactPanlert Prasanwon

Phramongkutklao hospital

panlertpat@gmail.com0830044801

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026