Digital Therapy for Fatty Liver Disease

Last updated: June 5, 2025
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Primary Biliary Cholangitis

Treatment

Software Group

Clinical Study ID

NCT07007741
XH-25-001
  • Ages 18-65
  • All Genders

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 Criteria

Inclusion

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

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

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Software Group
Phase:
Study Start date:
October 26, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200082
    China

    Active - Recruiting

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