NCT03972631

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle education	Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
BEHAVIORAL	Intensive lifestyle intervention	One to one intensive lifestyle intervention according to the diet and activity plan
BEHAVIORAL	Hypocaloric low-carbohydrate diet plan	A diet plan with restricted calorie and carbohydrate intake

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-04-01
• Completion: 2021-12-01
• First posted: 2019-06-03
• Last updated: 2019-06-13