"CAP" Fetge Gras. Lifestyle Modification Program in Catalonia.
Primary Purpose
Non-Alcoholic Fatty Liver Disease, Liver Diseases, Lifestyle, Healthy
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intervention CFG App
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- Fibroscan® with a CAP ≥ 300 dB/m and liver stiffness <8 Kpa.
Exclusion Criteria:
- Serious chronic disease (heart, respiratory, cancer, etc.).
- Chronic liver disease.
- Chronic kidney disease (FGR <60ml/min).
- Weight loss> 5% during the last three months.
- AUDIT- C> 8
- Impossibility to follow the recommended diet (for religious reasons, swallowing problems, etc.) or inability to perform physical activity.
- Inability to follow the scheduled visits to the intervention (institutionalized individuals, lack of autonomy, inability to walk, lack of a stable home, travel plans, etc.).
- Have been included in another weight loss advice program (>5 kg) during the 6 months prior to the selection visit (basal visit).
- History of having followed a low calorie diet (<900Kcal/day) for the last 6 months.
- History of surgical procedures to lose weight or intend to undergo bariatric surgery in the next 12 months.
- Hemoglobin A1c ≥ 9%.
- History of resection of the small or large intestine.
- History of inflammatory bowel disease.
- BMI> 40 or obesity of known endocrine origin (with the exception of treated hypothyroidism).
- Current treatment with systemic corticosteroids.
- Current use of medication for weight loss.
- Current treatment with steatogenic drugs.
- People participating in a clinical trial with drugs.
- Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
- Refusal to give informed consent.
Sites / Locations
- Núria FabrellasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intervention CFG App
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Rate of reduction in hepatic steatosis in people with MAFLD.
Secondary Outcome Measures
Liver steatosis improvement rate according to CAP value (dB/m)
Changes from baseline in weight (kg) at month 6 and month 12.
Changes from baseline in abdominal circumference (cm) and anthropometric variables at month 6 and 12.
Adherence to healthy lifestyle with
Changes from baseline in cardiovascular risk through REGICOR at month 6 and 12.
Changes from baseline in lipid profile (TG, total COL, HDL, LDL), glycemia and HbA1c at month 6 and month 12.
Changes from baseline in liver stiffness values for Fibroscan®, FIB-4 and NAFLD-score and on steatosis scores FLI, HSI, ION at month 6 and 12.
Changes from baseline in steatosis scores FLI, HSI, ION at month 6 and 12.
Changes from baseline in quality of life of individuals at month 6 and 12 and throughout the study throught EuroqoL questionnarie.
Satisfaction of individuals in the participation of the study throught adHoc questionnaire
Full Information
NCT ID
NCT04988633
First Posted
July 22, 2021
Last Updated
July 26, 2021
Sponsor
Hospital Clinic of Barcelona
Collaborators
University of Barcelona, Fundació Clínica per a la Recerca Biomèdica
1. Study Identification
Unique Protocol Identification Number
NCT04988633
Brief Title
"CAP" Fetge Gras. Lifestyle Modification Program in Catalonia.
Official Title
"CAP" Fetge Gras. Lifestyle Modification Program of Nurse Management Through a Mobile Application for Patients With MFLD.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
University of Barcelona, Fundació Clínica per a la Recerca Biomèdica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Liver Diseases, Lifestyle, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Phase III, single-centre, randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention CFG App
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Intervention CFG App
Intervention Description
Online healthy lifestyle education through an App. The intervention will consist of viewing educational videos on diet and exercise through an App. Videos will be uploaded to the app on a weekly basis, lasting 2-3.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
Standard tips for healthy lifestyles that are carried out in regular Primary Care practice. After day 1, where standard advice is received, follow-up visits are conducted at week 2, week 4, month 3, and month 6.
Primary Outcome Measure Information:
Title
Rate of reduction in hepatic steatosis in people with MAFLD.
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Liver steatosis improvement rate according to CAP value (dB/m)
Time Frame
Month 6 and 12
Title
Changes from baseline in weight (kg) at month 6 and month 12.
Time Frame
Month 6 and 12
Title
Changes from baseline in abdominal circumference (cm) and anthropometric variables at month 6 and 12.
Time Frame
Month 6 and 12
Title
Adherence to healthy lifestyle with
Time Frame
Month 6 and 12
Title
Changes from baseline in cardiovascular risk through REGICOR at month 6 and 12.
Time Frame
Month 6 and 12
Title
Changes from baseline in lipid profile (TG, total COL, HDL, LDL), glycemia and HbA1c at month 6 and month 12.
Time Frame
Month 6 and 12
Title
Changes from baseline in liver stiffness values for Fibroscan®, FIB-4 and NAFLD-score and on steatosis scores FLI, HSI, ION at month 6 and 12.
Time Frame
Month 6 and 12
Title
Changes from baseline in steatosis scores FLI, HSI, ION at month 6 and 12.
Time Frame
Month 6 and 12
Title
Changes from baseline in quality of life of individuals at month 6 and 12 and throughout the study throught EuroqoL questionnarie.
Time Frame
Month 6 and 12
Title
Satisfaction of individuals in the participation of the study throught adHoc questionnaire
Time Frame
D0, month 6, month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old
Fibroscan® with a CAP ≥ 300 dB/m and liver stiffness <8 Kpa.
Exclusion Criteria:
Serious chronic disease (heart, respiratory, cancer, etc.).
Chronic liver disease.
Chronic kidney disease (FGR <60ml/min).
Weight loss> 5% during the last three months.
AUDIT- C> 8
Impossibility to follow the recommended diet (for religious reasons, swallowing problems, etc.) or inability to perform physical activity.
Inability to follow the scheduled visits to the intervention (institutionalized individuals, lack of autonomy, inability to walk, lack of a stable home, travel plans, etc.).
Have been included in another weight loss advice program (>5 kg) during the 6 months prior to the selection visit (basal visit).
History of having followed a low calorie diet (<900Kcal/day) for the last 6 months.
History of surgical procedures to lose weight or intend to undergo bariatric surgery in the next 12 months.
Hemoglobin A1c ≥ 9%.
History of resection of the small or large intestine.
History of inflammatory bowel disease.
BMI> 40 or obesity of known endocrine origin (with the exception of treated hypothyroidism).
Current treatment with systemic corticosteroids.
Current use of medication for weight loss.
Current treatment with steatogenic drugs.
People participating in a clinical trial with drugs.
Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
Refusal to give informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Núria Fabrellas, PhD
Phone
932275400
Ext
1713
Email
nfabrellas@ub.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Carol, RN
Phone
932275400
Ext
3080
Email
mcarol@clinic.cat
Facility Information:
Facility Name
Núria Fabrellas
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Núria Fabrellas, PhD
Phone
932275400
Ext
1713
Email
nfabrellas@ub.edu
First Name & Middle Initial & Last Name & Degree
Marta Carol, RN
Phone
932275400
Ext
3080
Email
mcarol@clinic.cat
12. IPD Sharing Statement
Plan to Share IPD
No
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"CAP" Fetge Gras. Lifestyle Modification Program in Catalonia.
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