Lifestyle intervention is the most important management of non-alcoholic fatty liver diseases (NAFLD) patients. Weight reductions of 5-10% can improve non-alcoholic steatosis and fibrosis. However, the options for treatment in the clinics are limited. Therefore, in this study, we investigated the effectiveness of different lifestyle intervention strategies in NAFLD patients.
This is a multicenter, randomized clinical trial nested within a cohort study in overweight and obese non-alcoholic fatty liver diseases (NAFLD) patients. In this study, 1500 eligible patients will be recruited, and demographic information and clinical data will be collected at baseline. Among these, 292 participants who agree to be randomized will be randomized into two intervention groups, including lifestyle education (LE), and intensive lifestyle intervention with low-carbohydrate diet (ILI), aiming to induce a loss ≥ 10% of initial weight in 3 months. The remainder will chose the treatment which they prefer according to the clinical practice. At the 3th, 6th and 12th month, all the participants will be followed, and data will be collected to study the development of NAFLD in different lifestyle intervention groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
292
Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
One to one intensive lifestyle intervention according to the diet and activity plan
A diet plan with restricted calorie and carbohydrate intake
Change in BMI
Time frame: baseline, 3 month
Change in liver function biomarkers
ALT, AST
Time frame: baseline, 3 month
Liver Stiffness Measurement
LSM is suggested as degree of liver fibrosis
Time frame: baseline, 3 month
Fast Ultrasound Attenuation Parameter
FAP is suggested as degree of liver steatosis.
Time frame: baseline, 3 month
Change in BMI
Time frame: 6 month, 12 month
Change in liver function biomarkers
ALT, AST
Time frame: 6 month, 12 month
Change in blood pressure
Time frame: baseline, 3 month
Change in lipid
triglyceride, total cholesterol , LDL-C, and HDL-C
Time frame: baseline, 3 month
Change in glycemic markers
fasting glucose, fasting insulin, HbA1C
Time frame: baseline, 3 month
Change in body composition
muscle mass, fat percentage
Time frame: baseline, 3 month
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