Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT04988633
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2021-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"CAP" Fetge Gras. Lifestyle Modification Program in Catalonia.
Sponsor:
Hospital Clinic of Barcelona
Organization:
Study Overview
Official Title:
"CAP" Fetge Gras. Lifestyle Modification Program of Nurse Management Through a Mobile Application for Patients With MFLD.
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to investigate whether an online lifestyle modification program for people with Metabolic Associated Fatty Liver Disease (MAFLD) through a mobile application produces a significant reduction in liver steatosis and is associated with a higher rate of weight loss compared to standard recommendations currently indicated in Primary Care.
Detailed Description:
Chronic liver disease are very common and potentially severe. For the most part, they are diagnosed in an advanced stage, which prevents the introduction of curative treatments.
MAFLD is currently the most common cause of chronic liver disease affecting approximately 25% of the world's population. MAFLD is characterized by an excessive accumulation of liver fat associated with insulin resistance (IR) which is defined by the presence of steatosis in\> 5% of hepatocytes according to histological analysis.
Currently, the only effective strategy for treating MAFLD is weight loss. Several studies show that a 3-5% weight loss manages to reduce hepatic steatosis and associated metabolic parameters. Despite this, a reduction of at least 7-10% is required to improve fibrosis. Guidelines from the European Association for the Study of Liver Diseases (EASL) and the American Association for the Study of Liver Diseases (AASLD) recommend following an energy-restricted diet adjusted to the Mediterranean diet, excluding MAFLD-promoting components (processed products and high in added fructose), and perform physical activity in order to achieve this goal. However, it is a difficult goal to achieve and maintain over time. Epidemiological evidence recommends implementing structured lifestyle modification programs with the goal of losing weight.
In people with MFGNA, participation in structured lifestyle programs may be compromised by work and time constraints. An application-based online intervention may be more appropriate for young people, people of working age, and those living far from primary care. EHealth technology is a possible resource for promoting behavior change but is a little-studied field in lifestyles modification of people with MAFLD. Given the lack of information regarding lifestyle modification programs in people with MAFLD as the main therapeutic intervention in Primary Care (PC), we consider to analyze the effectiveness of an online program based on the Mediterranean diet with calorie restriction, associated with specific goals of weight loss and physical activity, which allows to reduce hepatic steatosis of individuals with MAFLD.
This study, along with studies of early detection of chronic liver disease through liver elastography "LiverScreen", aims to be the beginning of the approach to chronic liver disease in Primary Care. The aim of this study is to evaluate a strategy for treating MAFLD.
MAFLD is currently the most common cause of chronic liver disease affecting approximately 25% of the world's population. MAFLD is characterized by an excessive accumulation of liver fat associated with insulin resistance (IR) which is defined by the presence of steatosis in\> 5% of hepatocytes according to histological analysis.
Currently, the only effective strategy for treating MAFLD is weight loss. Several studies show that a 3-5% weight loss manages to reduce hepatic steatosis and associated metabolic parameters. Despite this, a reduction of at least 7-10% is required to improve fibrosis. Guidelines from the European Association for the Study of Liver Diseases (EASL) and the American Association for the Study of Liver Diseases (AASLD) recommend following an energy-restricted diet adjusted to the Mediterranean diet, excluding MAFLD-promoting components (processed products and high in added fructose), and perform physical activity in order to achieve this goal. However, it is a difficult goal to achieve and maintain over time. Epidemiological evidence recommends implementing structured lifestyle modification programs with the goal of losing weight.
In people with MFGNA, participation in structured lifestyle programs may be compromised by work and time constraints. An application-based online intervention may be more appropriate for young people, people of working age, and those living far from primary care. EHealth technology is a possible resource for promoting behavior change but is a little-studied field in lifestyles modification of people with MAFLD. Given the lack of information regarding lifestyle modification programs in people with MAFLD as the main therapeutic intervention in Primary Care (PC), we consider to analyze the effectiveness of an online program based on the Mediterranean diet with calorie restriction, associated with specific goals of weight loss and physical activity, which allows to reduce hepatic steatosis of individuals with MAFLD.
This study, along with studies of early detection of chronic liver disease through liver elastography "LiverScreen", aims to be the beginning of the approach to chronic liver disease in Primary Care. The aim of this study is to evaluate a strategy for treating MAFLD.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: