NCT07007741

Digital Therapy for Fatty Liver Disease

A Randomised Controlled Trial Study of the Effect of Fatty Liver Data Analysis and Management Software on the Effectiveness of Intervention in Patients With Non-alcoholic Fatty Liver Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Steatohepatitis, Nonalcoholic
• Nonalcoholic Fatty Liver

Interventions

Type	Name	Description
OTHER	Software Group	Download the "Fatty Liver Data Analysis and Management Software", register and update your profile, connect to a scale, and associate with a researcher and dietitian. Upload meal charts and weight and body fat data every day, adjust recipes according to the patient's exercise and diet every week, and customise one-on-one Q\&A according to the patient's uploaded photos every day. After enrolment, w12 and w24 were required to follow-up to complete relevant examinations and scales and collect data.

Timeline

• Start date: 2023-10-26
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-06-06
• Last updated: 2025-06-06

Locations

1 site across 1 country: China