Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-10-26
2025-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Life Group
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age 18-65 years old, 24kg/m2 ≤ BMI ≤ 35kg/m2
* Must be able to use smartphone
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Locations
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XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XH-25-001
Identifier Type: -
Identifier Source: org_study_id
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