Non-Alcoholic Fatty Liver DiseaseNCT04988633
"CAP" Fetge Gras. Lifestyle Modification Program in Catalonia.
A study testing Intervention CFG App in people with Non-Alcoholic Fatty Liver Disease and Liver Diseases, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Liver Diseases, Lifestyle, Healthy
- What is being tested?
- Intervention CFG App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Fibroscan® with a CAP ≥ 300 dB/m and liver stiffness <8 Kpa.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "CAP" Fetge Gras. Lifestyle Modification Program of Nurse Management Through a Mobile Application for Patients With MFLD.
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.
Read the 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.
- Being tested
- Intervention CFG App, Control Group
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention CFG AppBehavioural
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.
Control GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention CFG App | Experimental | Online healthy lifestyle education through an App. The intervention will consist of viewing educational videos on diet and exercise through an App. Receives: Behavioral: Intervention CFG App |
| Control Group | Experimental | Standard tips for healthy lifestyles that are carried out in regular Primary Care practice. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reduction in hepatic steatosis in people with MAFLD.
Measured: Month 12
Secondary outcomes (10)
Liver steatosis improvement rate according to CAP value (dB/m)
Measured: Month 6 and 12
Changes from baseline in weight (kg) at month 6 and month 12.
Measured: Month 6 and 12
Changes from baseline in abdominal circumference (cm) and anthropometric variables at month 6 and 12.
Measured: Month 6 and 12
Adherence to healthy lifestyle with
Measured: Month 6 and 12
Changes from baseline in cardiovascular risk through REGICOR at month 6 and 12.
Measured: Month 6 and 12
Changes from baseline in lipid profile (TG, total COL, HDL, LDL), glycemia and HbA1c at month 6 and month 12.
Measured: Month 6 and 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.
Measured: Month 6 and 12
Changes from baseline in steatosis scores FLI, HSI, ION at month 6 and 12.
Measured: 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.
Measured: Month 6 and 12
Satisfaction of individuals in the participation of the study throught adHoc questionnaire
Measured: D0, month 6, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 May 2021
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, single-centre, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988633
- Sponsor's protocol ID
- CFG
- Status last verified
- Jul 2021
- First submitted
- 22 Jul 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "CAP" Fetge Gras. Lifestyle Modification Program of Nurse Management Through a Mobile Application for Patients With MFLD.
- ClinicalTrials.gov ID
- NCT04988633
- Acronym / sponsor ID
- CFG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III, single-centre, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention CFG App | Experimental | Behavioral: Intervention CFG AppOnline healthy lifestyle education through an App. The intervention will consist of viewing educational videos on diet and exercise through an App. |
| Control Group | Experimental | Behavioral: Control GroupStandard tips for healthy lifestyles that are carried out in regular Primary Care practice. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years old
- Fibroscan® with a CAP ≥ 300 dB/m and liver stiffness <8 Kpa.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention CFG AppOnline 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. | Behavioural | Intervention CFG App |
| Control GroupStandard 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. | Behavioural | Control Group |
Primary outcome
Rate of reduction in hepatic steatosis in people with MAFLD.
Time frame: Month 12
10 secondary outcomes
Liver steatosis improvement rate according to CAP value (dB/m)
Time frame: Month 6 and 12
Changes from baseline in weight (kg) at month 6 and month 12.
Time frame: Month 6 and 12
Changes from baseline in abdominal circumference (cm) and anthropometric variables at month 6 and 12.
Time frame: Month 6 and 12
Adherence to healthy lifestyle with
Time frame: Month 6 and 12
Changes from baseline in cardiovascular risk through REGICOR at month 6 and 12.
Time frame: Month 6 and 12
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
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
Changes from baseline in steatosis scores FLI, HSI, ION at month 6 and 12.
Time frame: 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.
Time frame: Month 6 and 12
Satisfaction of individuals in the participation of the study throught adHoc questionnaire
Time frame: D0, month 6, month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention CFG App in people with Non-Alcoholic Fatty Liver Disease and Liver Diseases, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reduction in hepatic steatosis in people with MAFLD. (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.