Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - NAFLD patient (CAP value \>248 (dB/m)) - Age 18-65 years old, 24kg/m2 ≤ BMI ≤ 35kg/m2 - Must be able to use smartphone Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (1)

XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China