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Digital Therapy for Fatty Liver Disease

RECRUITINGN/ASponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Actively Recruiting
PhaseN/A
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Started2023-10-26
Est. completion2025-12-31
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07007741

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.

Eligibility

Age: 18 Years – 65 YearsHealthy volunteers accepted
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

Conditions3

Liver DiseaseNonalcoholic Fatty LiverSteatohepatitis, Nonalcoholic

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