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Clinical Trials in China / NCT07007741
Active, not recruiting Not applicable

Digital Therapy for Fatty Liver Disease

NCT07007741 · tracked via the Priya Life Science China tracker
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Not applicable
Started
2022-11-19
Last updated
2026-08-12

Condition(s) studied

Steatohepatitis, NonalcoholicNonalcoholic Fatty Liver

Investigational drug(s) / intervention(s)

Software Group

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

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

More Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07007741 on ClinicalTrials.gov ↗ ← All trials in China