Digital Therapy for Fatty Liver Disease

NCT07007741 — Not applicable, Active not recruiting, 141 participants, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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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

Registry	NCT07007741, acronym DTFLD
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	141 (Actual)
Sponsor	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Conditions	Steatohepatitis, Nonalcoholic, Nonalcoholic Fatty Liver
Interventions	Software Group (Other)
Dates	start 2022-11-19, primary completion 2026-07-01, completion 2026-12-31 (estimated), first posted 2025-06-06, last updated 2026-08-12
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Software Group	Experimental	Other: Software Group	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.
Life Group	No intervention		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.

Software Group (Other): 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.

+Outcome measures

Primary outcomes

Reduced body weight rate [Week 12 & Week 24]: The Fatty Liver Data Analysis and Intervention Software (FLADIS) was used to assist clinicians with remote data monitoring and follow-up of NAFLD patients, as well as lifestyle intervention guidance and follow-up management, and to evaluate the effectiveness of the FLADIS intervention on the degree of weight loss in patients with NAFLD.

Secondary outcomes

Decreased CAP Value (Indicating Reduced Liver Fat) [Week 12 & Week 24]: The Fatty Liver Data Analysis and Intervention Software (FLADlS) was used to assist clinicians with remote data monitoring and follow-up of NAFLD patients,as well as lifestye intervention guidance and follow-up management, and to evaluate the effectiveness of the FLADIS intervention in restoring NAFLD patients' Controlled Attenuation Parameter (CAP) values to normal ranges (CAP < 248 dB/m)

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine	Shanghai, Shanghai Municipality	China

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