Digital Therapy for Fatty Liver Disease (DTFLD)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Nonalcoholic Fatty Liver; Steatohepatitis, Nonalcoholic

Treatments: Other: Software Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07007741

XH-25-001

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Software Group

Experimental group

Description:

Download the Fatty Liver Data Analysis and Intervention Software and associate it with the researcher. Baseline data was collected, a health record was created, and the Weight and Lipo Meter that came with the software was linked to the software for data collection. The researcher assesses the participant through the software (on the part of the physician) and develops a diet and exercise plan based on the participant's individual circumstances. At weeks 12 and 24 after enrolment, study participants were notified of follow-up examinations to collect data on body weight, waist and hip circumference, blood tests, liver function, kidney function, blood lipids, fasting blood glucose, fasting insulin, glycated haemoglobin, abdominal ultrasound, liver transient elasticity, and body composition measurements.

Treatment:

Other: Software Group

Life Group

No Intervention group

Description:

Under the guidance of the programme specialist, the enrolled study participants collected baseline data and established health records. Professional clinicians will provide offline health education and lifestyle guidance according to the latest Chinese NAFLD prevention and treatment guidelines. At weeks 12 and 24 after enrolment, study participants were notified of follow-up examinations to collect data on body weight, waist and hip circumference, blood tests, liver function, kidney function, blood lipids, fasting blood glucose, fasting insulin, glycated haemoglobin, abdominal ultrasound, liver transient elasticity, and body composition measurements.