Effect of Smartphone-assisted Lifestyle Modification Intervention in MAFLD Patients

Phase 3

Completed

• Conditions: Metabolic Associated Fatty Liver Disease; Metabolic diseases; Nonalcoholic fatty liver disease; Diet; Lifestyle; Smartphone

• Registration Number: TCTR20210304002
• Lead Sponsor: Faculty of Medicine, Prince of Songkla University

Brief Summary

Encouraging LSI and delivering MAFLD information via a social media application (LINE official account) to patients with MAFLD demonstrated a better outcome of liver stiffness measurement than SOC.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-04
• Study Completion: 2022-08-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

1. Hepatic steatosis diagnosed by imaging techniques or histology within 1 year before screening AND met the definition of MAFLD according to international consensus 2020, 2. Patients are smartphone users with LINE application installed in their smartphones, and use LINE application regularly in daily life, 3. In patients with diabetes mellitus type 2, and/or dyslipidemia, the dosage of medications to treat diabetes and dyslipidemia is stable for at least 3 months

Exclusion Criteria

1. Ongoing treatment with Thiazolidinedione and GLP1 group in type 2 diabetic patients, tamoxifen in breast cancer patients., 2. Coexisted with any active malignancies (with or without treatment), 3. Previous treatment of any malignancies within 6 months., 4. Significant of alcohol consumption (greater than or equal to 21 standard drinks per week in male and greater than or equal to 14 standard drink in female), 5. Concomitant infection or liver disease, which has exact treatment, such as chronic hepatitis B, chronic hepatitis C, autoimmune hepatitis, Wilson(s) disease, 6. Cirrhosis evidence from imaging techniques or histology or LSM more than 17 kPa, 7. Unstable cardiovascular/ cerebrovascular/ pulmonary conditions e.g. recent myocardial infarction or COPD exacerbation within 1 year, 8. Patients unwilling to participate in the study, 9. Pregnancy, 10. Conditions which make unreliable VCTE result

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hepatic steatosis At week 24 Controlled attenuation parameter by Fibroscan

Secondary Outcome Measures

Name	Time	Method
Body mass index At week 24 kg/m2,Metabolic parameters At week 24 Blood tests, Bioimpedance Analysis