Clinical Trial

Digital Therapy for Fatty Liver Disease

Study acronym: DTFLD
Active, Not Recruiting
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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.
Protocol Amendment History 2 changes
notable Enrollment increased: 120 -> 141 participants 2026-08-13
notable Primary completion pushed: 2026-03-31 -> 2026-07-01 2026-08-13
Trial Details
NCT Number NCT07007741
Lead Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions Steatohepatitis, Nonalcoholic, Nonalcoholic Fatty Liver
Enrollment 141 participants
Start Date 2022-11-19
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-12