Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults

Conditions
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Non-Alcoholic Fatty Liver Disease, Obesity

Intervention / Treatment
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* Behavioral: Lifestyle education
* Behavioral: Intensive lifestyle intervention
* Behavioral: Hypocaloric low-carbohydrate diet plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or women aged 18-65 years; Confirmed diagnosis of NAFLD according to the 2018 Chinese Guidelines for Prevention and Treatment of NAFLD; Body mass index (BMI)of 25.0 to 35.0 kg/m2; Patients without medicine for treatment of NAFLD; Exclusion Criteria: Patients with other diseases that can lead to fatty liver; Patients use amiodaron, methotrexate, tamoxifen, glucocorticoid, estrogen, and the other medications that affect weight within 3 months; Patients with serious liver dysfunction (AST or/and ALT >3 times of the upper limit of normal), or renal dysfunction (serum creatinine >the upper limit of normal); Patients with diseases that need control of dietary protein intake; Patients with diseases that affect food digestion and absorption; Patients with diagnosed diabetes or those with significantly elevated blood glucose (fasting blood glucose ≥7.0 mmol/L and/or random blood glucose ≥11.1 mmol/L); Patients with severe cardiovascular and cerebrovascular diseases or severe hypertension (Grade 3); anemia; mental illness or memory disorder; epilepsy or antiepileptic treatment; Patients with secondary obesity; Patients with cancer, active tuberculosis, AIDS and other infectious diseases; Pregnancy or lactation; Physical disability.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lifestyle education<br>The participants in this group will be provided usual recommendation, including the diet principles, activity guideline and behavioral strategies at baseline. In addition, the participants will have access to an APP, with which the participants could learn more information of body weight management, and keep records of diet, activity and body weight during the study. | Behavioral: Lifestyle education<br>* Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.<br>|
| Experimental: Intensive Lifestyle Intervention<br>The participants in this group will be provided a comprehensive intervention, including goal setting, one to one support by the lifestyle counselors, and meal replacement products, in addition to the information and APP which are provided to the Lifestyle education group. | Behavioral: Lifestyle education<br>* Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.<br>Behavioral: Intensive lifestyle intervention<br>* One to one intensive lifestyle intervention according to the diet and activity plan<br>Behavioral: Hypocaloric low-carbohydrate diet plan<br>* A diet plan with restricted calorie and carbohydrate intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI |  | baseline, 3 month | 
| Change in liver function biomarkers | ALT, AST | baseline, 3 month | 
| Liver Stiffness Measurement | LSM is suggested as degree of liver fibrosis | baseline, 3 month | 
| Fast Ultrasound Attenuation Parameter | FAP is suggested as degree of liver steatosis. | baseline, 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI |  | 6 month, 12 month | 
| Change in liver function biomarkers | ALT, AST | 6 month, 12 month | 
| Change in blood pressure |  | baseline, 3 month | 
| Change in lipid | triglyceride, total cholesterol , LDL-C, and HDL-C | baseline, 3 month | 
| Change in glycemic markers | fasting glucose, fasting insulin, HbA1C | baseline, 3 month | 
| Change in body composition | muscle mass, fat percentage | baseline, 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lifestyle interventions, Low-carbohydrate diet