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Active (not recruiting) Not applicable NCT07007741

Digital Therapy for Fatty Liver Disease

No applicable phase (e.g. observational)
Conditions: Steatohepatitis, Nonalcoholic Nonalcoholic Fatty Liver

Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

trial.available_in: БГ
Overview
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 can participate
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
Interventions
Software Group
OTHER
Locations 1
China (1)
XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Shanghai , Shanghai Municipality
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
26.10.2023
Completion date
31.12.2026
Registry ID
NCT07007741
Source
clinicaltrials.gov
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