Digital Therapy for Fatty Liver Disease

Not Applicable

Recruiting

• Conditions: Steatohepatitis, Nonalcoholic; Nonalcoholic Fatty Liver

• Registration Number: NCT07007741
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

This study is a randomised controlled trial of the clinical application of the Fatty Liver Data Analysis and Intervention System (FLDAS) to compare the effectiveness of traditional lifestyle interventions in patients with fatty liver with digital therapies combining software and hardware devices; to validate the effectiveness of digital therapies in patients with fatty liver; and to evaluate the effectiveness of remote lifestyle (diet and exercise) interventions.

Researchers conducted a randomised controlled trial to compare the effectiveness of a traditional lifestyle intervention for patients with fatty liver with a remote lifestyle (diet and exercise) intervention combining digital therapy software and hardware devices. When the effectiveness of this programme is validated, it could help clinicians improve the efficiency of lifestyle interventions for patients with fatty liver and address the growing need for primary care for patients with fatty liver as an innovative approach to disease intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-26
• Status Verified: 2025-01
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• NAFLD patient (CAP value >248 (dB/m))
• Age 18-65 years old, 24kg/m2 ≤ BMI ≤ 35kg/m2
• Must be able to use smartphone

Exclusion Criteria

• Inherited metabolic or autoimmune liver disease
• Drug/toxic/alcoholic/biliary liver injury, cirrhosis or any end-stage liver disease
• Hepatic or extrahepatic malignant tumours
• Pregnant and lactating women
• Patients considered ineligible by the investigator's clinical judgment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduced body weight rate	Week 12 & Week 24	The Fatty Liver Data Analysis and Intervention Software (FLADIS) was used to assist clinicians with remote data monitoring and follow-up of NAFLD patients, as well as lifestyle intervention guidance and follow-up management, and to evaluate the effectiveness of the FLADIS intervention on the degree of weight loss in patients with NAFLD.

Secondary Outcome Measures

Name	Time	Method
Decreased CAP Value (Indicating Reduced Liver Fat)	Week 12 & Week 24	The Fatty Liver Data Analysis and Intervention Software (FLADlS) was used to assist clinicians with remote data monitoring and follow-up of NAFLD patients,as well as lifestye intervention guidance and follow-up management, and to evaluate the effectiveness of the FLADIS intervention in restoring NAFLD patients' Controlled Attenuation Parameter (CAP) values to normal ranges (CAP \< 248 dB/m)

Trial Locations

Locations (1)

XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China