Steatohepatitis, NonalcoholicNUTRINAFLDNCT05946330
Nutritional Intervention IN Nash NON-ALCOHOLIC (NAFLD).
A study testing NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD). in people with Steatohepatitis, Nonalcoholic and Steatosis, run by Universidade Federal do Paraná at 1 site in Brazil.
Trial summary
The goal of this randomized clinical trial with adults is to discuss the effectiveness of the nutritionist's educational interventions in users diagnosed with NAFLD, compared to the usual medical follow-up of users treated at the Hepatic Steatosis Ambulatory of the Complexo Hospital de Clinicas of the Federal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Steatohepatitis, Nonalcoholic, Steatosis, Liver Diseases
- What is being tested?
- NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Feb 2023to 31 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory users with a diagnosis of NAFLD in the medical record will be included. For the purposes of eligibility of the patient under study, users must not be significant alcoholics and this questioning, self-reported, is provided for in the nutritionist's consultation protocol. Alcohol consumption is considered significant if defined as > 21 drinks per week in men and > 14 drinks per week in women in a two-year period prior to baseline liver histology.
Who cannot join
- People who are not able to answer the nutritional literacy questionnaire with the help of the researcher will not be included in the research or who, during the research, show accumulation of hepatic fat due to secondary causes, such as the use of steatogenic drugs or hereditary diseases, as well as patients who report frequent alcohol intake. Patients with positive serology for hepatitis B and C, HIV, as well as patients with disabsorptive diseases (Chron's Disease, Celiac Disease), with chronic kidney diseases, who are on the waiting list for bariatric surgery, pregnant and lactating women will also be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, 80060-900
About this study
Official title: Nutritional Education Intervention in Non-Alcoholic Fatty Liver Disease -Nafld
The goal of this randomized clinical trial with adults is to discuss the effectiveness of the nutritionist's educational interventions in users diagnosed with NAFLD, compared to the usual medical follow-up of users treated at the Hepatic Steatosis Ambulatory of the Complexo Hospital de Clinicas of the Federal University of Paraná (CHCUFPR) in adults diagnosed with liver disease. The sample will consist of patients routinely monitored at the Hepatic Steatosis outpatient clinic diagnosed with non-alcoholic fatty liver disease. Patients allocated in the study will be randomized 1:1 and followed up for one (1) year, intervention group (IG) with nutritionist consultations, nutritional diagnosis and educational intervention with agreement on individual goals. Patients in the Control Group (CG) will maintain the usual outpatient care. Participants will have clinical, anthropometric and sociodemographic data collected and food consumption data will be carried out during the nutrition consultations, as well as the application of the NLS-Br Nutritional Literacy questionnaire to verify literacy. During the nutrition consultation, a 24-hour recall will be carried out to collect information on food consumption. They will also be carried out as monthly telephone contacts or messages via instant messaging application, to solve the doubts of the participants and notify them of upcoming meetings, and subsequent comparison of the LN in the target population. All interventions will be recorded in specific instruments for this purpose.
Researchers will compare intervention group (IG) and Control Group (CG) and to see the effects of nutritional intervention. The expected primary outcome will be weight loss of 5% to 10% of the initial weight and the secondary outcomes will be: reduction in abdominal circumference and body mass index, and improvement in the levels of liver transaminases. Data will be analyzed with descriptive and inferential statistics.
Read the detailed description
The research intends to discuss the effectiveness of the nutritionist's educational interventions in users diagnosed with NAFLD, compared to the usual medical follow-up of users treated at the Hepatic Steatosis Ambulatory of the Complexo Hospital de Clinicas of the Federal University of Paraná (CHCUFPR).
Considering:
- That NAFLD e has gained alarming proportions, affecting 25 to 30% of the world's population and its occurrence is associated with overweight, insulin resistance and metabolic syndrome;
- That the morbidity and mortality associated with NAFLD has increased significantly, along with the growth of overweight in the population, and that there is still no specific marker for the diagnosis, nor a pharmacological treatment for the disease
- That prevention and treatment are based on lifestyle changes, with the adoption of healthy eating habits, which must necessarily lead to weight loss, in order to improve the condition
- That Food and Nutrition Education (EAN) is a tool for adopting healthy eating habits;
- That the Process of Care in Nutrition (PCN) is a tool that covers the domains of action of nutritionists in their clinical practice
- That nutritional literacy, understood as the ability to process and understand nutritional information is a factor for the success of EAN;
- That EAN can be seen as a set of experiences designed to facilitate the voluntary adoption of behavioral changes related to nutrition, health and well-being; It is
- That the development of educational strategies that promote better health indicators since low LN is associated with an increase in diet-related chronic diseases.
This research is justified considering that the nutritionist's role can help reduce and improve the factors that aggravate NAFLD and improve quality of life.
RESEARCH OBJECTIVE:
MAIN GOAL
-Verify the effectiveness of the educational action of the nutritionist for NAFLD and its interference in the nutritional status of the population of users of the Hepatic Steatosis Ambulatory of the Complexo de Hospital de Clínicas of UFPR.
SPECIFIC OBJECTIVES
- To characterize the nutritional profile of users with NAFLD at the Hepatic Steatosis Outpatient Clinic of the Complexo de Hospital de Clínicas of UFPR.
- Identify the interference of educational activity in nutrition literacy
- Compare dietary, anthropometric, clinical and functional indicators after intervention;
SOCIAL RELEVANCE:
Non-alcoholic fatty liver disease (NAFLD) is currently considered an epidemic disease, with a prevalence of 10 to 24% in the general population and 57% to 74% among obese people. Its presentation and severity can vary significantly, from a simple steatosis (deposition of fatty acids without inflammation) to Non-Alcoholic Steatohepatitis (NASH) with the presence of inflammation, ballooning and liver fibrosis in its final stage. There is an association of the disease with central obesity, insulin resistance and dyslipidemia. With the increase in the incidence of overweight and Metabolic Syndrome in the general population, NAFLD has become a serious public health problem, being considered the hepatic manifestation of the Metabolic Syndrome.
In most obese individuals or with adequate body mass index (BMI), and in treatment of other comorbidities, NAFLD may be present, with or without laboratory alterations such as elevations in aminotransferase levels, and for diagnostic confirmation it is necessary to perform exams such as ultrasound, or MRI or liver biopsy.
Currently, NAFLD does not have drugs that can be used for targeted conventional treatment, as it can only be treated and alleviated by controlling metabolic disorders. Thus, the treatment of NAFLD aims to reduce insulin resistance and oxidative stress, in addition to controlling associated conditions such as obesity, diabetes mellitus, dislipidemia and also to reduce inflammation and liver fibrosis. As the clinical picture of NAFLD becomes clearer, there are also challenges to developing an effective treatment. Thus, it appears that currently there are no pharmaceutical therapies approved by the Food and Drug Administration (FDA) to treat nonalcoholic steatosis (Nonalcoholic steatohepatitis - NASH).
The improvement of the NAFLD condition necessarily involves a decrease in the mass of adipose tissue. However, it is emphatic that drastic caloric restrictions, despite leading to rapid weight loss, are not recommended due to the increased concentration of circulating fatty acids, mobilized from the adipose tissue, which can increase their influx into the liver, aggravating the condition.
Although sustained weight loss of 3% to 5% can already lead to clinically significant reductions in some cardiovascular risk factors, weight losses greater than this margin yield greater benefits. An initial goal of losing 5% to 10% of the initial weight in six months is feasible to reduce complications. For this to happen, one of the tools is diet therapy monitoring and Food and Nutrition Education (EAN).
EAN is a set of systematized strategies to encourage the culture and appreciation of food, conceived in recognition of the need to respect, but also to adjust beliefs, values, attitudes, practices and social relationships that are established around food, with a view to economic and social access to adequate food in quality and quantity, which meets the objectives of health, pleasure and social life.
Still, the strengthening of ties with the multidisciplinary team, with the inclusion of a nutritionist in the systematized diet therapy educational activity, can increase the quality of life of the population under study.
SCIENTIFIC BACKGROUND: In the world, malnutrition in all its forms, including malnutrition, obesity and other dietary risks, for the development of chronic non-communicable diseases (NCDs), corresponds to 19% of the causes of illnesses and premature deaths in everyone. Among the NCDs related to malnutrition, non-alcoholic fatty liver disease (NAFLD) stands out, a syndrome that occurs in non-alcoholic patients, but who present liver damage histologically indistinguishable from alcoholic steatohepatitis.
CASUISTRY Nutritional intervention, when followed correctly, is effective in treating NAFLD in patients who achieve a minimum weight loss of 5% of their baseline body weight after 6 months of dietary therapy. Important alterations in the parameters of insulin resistance and metabolic syndrome are observed in these patients. Even an average reduction of only 2% of the initial body weight (non-adherent group) led to a decrease in some anthropometric parameters, such as BMI and waist circumference, when compared with baseline values. However, patients who lost at least 5% of their initial weight (adherent group) showed more pronounced reductions in these parameters, in addition to improvements in waist-hip ratio, glucose, insulin, HDL-C and LDL-C, alterations not observed in patients non-adherent.
RESEARCH MATERIAL:
For data collection, a form with clinical, dietary and socioeconomic data prepared by the researchers will be used. For the analysis of food intake, a 24-hour recall will be used and the assessment of Nutritional Literacy will be measured using the Nutritional Literacy Scale - NLS - Brazilian version.
PROPOSED METHOD:
Randomized controlled clinical trial with division into two groups (GI and CG) matched 1 to 1. Essentially, it is a study in which participants already seen at the Hepatic Steatosis Outpatient Clinic will be invited to participate and will be randomly allocated (participants are randomized) to receive one or more interventions. Clinical trial results can be directly incorporated into everyday clinical practice. Allocation to the intervention will be performed by simple randomization technique in a 1:1 ratio.
The intervention group will receive individual nutrition education actions with nutrition consultation (in person at the beginning and at 180 days of the intervention and phone calls and text messages at 30, 60, 90, 120 and 150, 240 and 300 days of follow-up. The group The control will receive the usual care at the Outpatient Clinic. The collection of clinical, anthropometric, sociodemographic and food consumption data will be carried out during the nutrition consultations, as well as the application of the NLS-Br Nutritional Literacy questionnaire to verify literacy. During the nutrition consultation A 24-hour recall will be carried out to collect information on food consumption.
They will also be carried out as monthly telephone contacts or messages via instant messaging application, to solve the doubts of the participants and notify them of upcoming meetings, and subsequent comparison of the LN in the target population. All interventions will be recorded in specific instruments for this purpose
EXPECTED OUTCOME It is expected that patients assisted by the nutritionist will have an improvement in the prognosis of non-alcoholic fatty liver disease (NAFLD), reduction in body weight and centripetal adipose mass, modification of lifestyle and increase in nutritional literacy.
- Being tested
- NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD).
- Keywords
- Adult Health, Health Education, Nutrition Literacy, Nutrition Education,, Non-Alcoholic Fatty Liver Disease (NAFLD)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Diseases, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD).Behavioural
The intervention group will receive educational actions in individual nutrition with nutrition consultation (in person at the beginning and at 180 days of the intervention and phone calls and text messages at 30, 60, 90, 120 and 150, 240 and 300 days of follow-up
| Study group | Role | What they receive |
|---|---|---|
| Patients will be followed up for one year by nutritionist intervention, on individual goals | Experimental | Patients allocated in the study will be randomized 1:1 and followed up for one (1) year, intervention group (IG) with nutritionist consultations, nutritional diagnosis and educational intervention with agreement on individual goals. Receives: Behavioral: NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD). |
| Control Group (CG) will maintain the usual outpatient care. | Active comparator | Patients in the Control Group (CG) will maintain the usual outpatient care. Receives: Behavioral: NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss of 5% to 10% of body weight, decrease in waist circumference (WC)
The primary clinical outcomes expected for this study are weight loss of 5% to 10% of body weight, decrease in waist circumference (WC), as well as changes in dietary intake pattern, laboratory and anthropometric changes at 180 and 360 days.
Measured: changes at 180 and 360 days.
Secondary outcomes (1)
Cessation of the progression of NAFLD
Cessation of the progression of NAFLD, through liver enzymes, improvement in the prognosis of cure of NAFLD, continued slimming, improvement in consumption pattern, with comparison of three food recalls, improvement in self-reported quality of life.
Measured: changes in 180 and 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start22 Feb 2023
- Primary completion23 Jun 2023
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatohepatitis, NonalcoholicStudies 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
- Allocation to the intervention will be performed by simple randomization technique in a 1:1 ratio. The intervention group will receive individual nutrition education actions with nutrition consultation (in person at the beginning and at 180 days of the intervention and phone calls and text messages at 30, 60, 90, 120 and 150, 240 and 300 days of follow-up. The group The control will receive the usual care at the Outpatient Clinic. The collection of clinical, anthropometric, sociodemographic and food consumption data will be carried out during the nutrition consultations, as well as the application of the NLS-Br Nutritional Literacy questionnaire to verify literacy. During the nutrition consultation A 24-hour recall will be carried out to collect information on food consumption.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doutorado Enfermagem, Universidade Federal do Paraná
- Investigators
- Maria F Mantovani, Dr, Principal investigator, Universidade Federal do ParanáMaria E Schieferdecker, Dr, Study chair, Universidade Federal do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946330
- Sponsor's protocol ID
- UFPRENFERMAGEM
- Other IDs
- UFPRENFERMAGEM
- Acronym
- NUTRINAFLD
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the Informed Consent Form (TCLE), signed by the participants, I affirm that the collected data will not be shared with other studies.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Education Intervention in Non-Alcoholic Fatty Liver Disease -Nafld
- ClinicalTrials.gov ID
- NCT05946330
- Acronym / sponsor ID
- NUTRINAFLD / UFPRENFERMAGEM
- Keywords
- Adult Health, Health Education, Nutrition Literacy, Nutrition Education,, Non-Alcoholic Fatty Liver Disease (NAFLD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade Federal do ParanáUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 14 Jul 2023 (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 goal of this randomized clinical trial with adults is to discuss the effectiveness of the nutritionist's educational interventions in users diagnosed with NAFLD, compared to the usual medical follow-up of users treated at the Hepatic Steatosis Ambulatory of the Complexo Hospital de Clinicas of the Federal University of Paraná (CHCUFPR) in adults diagnosed with liver disease. The sample will consist of patients routinely monitored at the Hepatic Steatosis outpatient clinic diagnosed with non-alcoholic fatty liver disease. Patients allocated in the study will be randomized 1:1 and followed up for one (1) year, intervention group (IG) with nutritionist consultations, nutritional diagnosis and educational intervention with agreement on individual goals. Patients in the Control Group (CG) will maintain the usual outpatient care. Participants will have clinical, anthropometric and sociodemographic data collected and food consumption data will be carried out during the nutrition consultations, as well as the application of the NLS-Br Nutritional Literacy questionnaire to verify literacy. During the nutrition consultation, a 24-hour recall will be carried out to collect information on food consumption. They will also be carried out as monthly telephone contacts or messages via instant messaging application, to solve the doubts of the participants and notify them of upcoming meetings, and subsequent comparison of the LN in the target population. All interventions will be recorded in specific instruments for this purpose.
Researchers will compare intervention group (IG) and Control Group (CG) and to see the effects of nutritional intervention. The expected primary outcome will be weight loss of 5% to 10% of the initial weight and the secondary outcomes will be: reduction in abdominal circumference and body mass index, and improvement in the levels of liver transaminases. Data will be analyzed with descriptive and inferential statistics.
Detailed description
The research intends to discuss the effectiveness of the nutritionist's educational interventions in users diagnosed with NAFLD, compared to the usual medical follow-up of users treated at the Hepatic Steatosis Ambulatory of the Complexo Hospital de Clinicas of the Federal University of Paraná (CHCUFPR).
Considering:
- That NAFLD e has gained alarming proportions, affecting 25 to 30% of the world's population and its occurrence is associated with overweight, insulin resistance and metabolic syndrome;
- That the morbidity and mortality associated with NAFLD has increased significantly, along with the growth of overweight in the population, and that there is still no specific marker for the diagnosis, nor a pharmacological treatment for the disease
- That prevention and treatment are based on lifestyle changes, with the adoption of healthy eating habits, which must necessarily lead to weight loss, in order to improve the condition
- That Food and Nutrition Education (EAN) is a tool for adopting healthy eating habits;
- That the Process of Care in Nutrition (PCN) is a tool that covers the domains of action of nutritionists in their clinical practice
- That nutritional literacy, understood as the ability to process and understand nutritional information is a factor for the success of EAN;
- That EAN can be seen as a set of experiences designed to facilitate the voluntary adoption of behavioral changes related to nutrition, health and well-being; It is
- That the development of educational strategies that promote better health indicators since low LN is associated with an increase in diet-related chronic diseases.
This research is justified considering that the nutritionist's role can help reduce and improve the factors that aggravate NAFLD and improve quality of life.
RESEARCH OBJECTIVE:
MAIN GOAL
-Verify the effectiveness of the educational action of the nutritionist for NAFLD and its interference in the nutritional status of the population of users of the Hepatic Steatosis Ambulatory of the Complexo de Hospital de Clínicas of UFPR.
SPECIFIC OBJECTIVES
- To characterize the nutritional profile of users with NAFLD at the Hepatic Steatosis Outpatient Clinic of the Complexo de Hospital de Clínicas of UFPR.
- Identify the interference of educational activity in nutrition literacy
- Compare dietary, anthropometric, clinical and functional indicators after intervention;
SOCIAL RELEVANCE:
Non-alcoholic fatty liver disease (NAFLD) is currently considered an epidemic disease, with a prevalence of 10 to 24% in the general population and 57% to 74% among obese people. Its presentation and severity can vary significantly, from a simple steatosis (deposition of fatty acids without inflammation) to Non-Alcoholic Steatohepatitis (NASH) with the presence of inflammation, ballooning and liver fibrosis in its final stage. There is an association of the disease with central obesity, insulin resistance and dyslipidemia. With the increase in the incidence of overweight and Metabolic Syndrome in the general population, NAFLD has become a serious public health problem, being considered the hepatic manifestation of the Metabolic Syndrome.
In most obese individuals or with adequate body mass index (BMI), and in treatment of other comorbidities, NAFLD may be present, with or without laboratory alterations such as elevations in aminotransferase levels, and for diagnostic confirmation it is necessary to perform exams such as ultrasound, or MRI or liver biopsy.
Currently, NAFLD does not have drugs that can be used for targeted conventional treatment, as it can only be treated and alleviated by controlling metabolic disorders. Thus, the treatment of NAFLD aims to reduce insulin resistance and oxidative stress, in addition to controlling associated conditions such as obesity, diabetes mellitus, dislipidemia and also to reduce inflammation and liver fibrosis. As the clinical picture of NAFLD becomes clearer, there are also challenges to developing an effective treatment. Thus, it appears that currently there are no pharmaceutical therapies approved by the Food and Drug Administration (FDA) to treat nonalcoholic steatosis (Nonalcoholic steatohepatitis - NASH).
The improvement of the NAFLD condition necessarily involves a decrease in the mass of adipose tissue. However, it is emphatic that drastic caloric restrictions, despite leading to rapid weight loss, are not recommended due to the increased concentration of circulating fatty acids, mobilized from the adipose tissue, which can increase their influx into the liver, aggravating the condition.
Although sustained weight loss of 3% to 5% can already lead to clinically significant reductions in some cardiovascular risk factors, weight losses greater than this margin yield greater benefits. An initial goal of losing 5% to 10% of the initial weight in six months is feasible to reduce complications. For this to happen, one of the tools is diet therapy monitoring and Food and Nutrition Education (EAN).
EAN is a set of systematized strategies to encourage the culture and appreciation of food, conceived in recognition of the need to respect, but also to adjust beliefs, values, attitudes, practices and social relationships that are established around food, with a view to economic and social access to adequate food in quality and quantity, which meets the objectives of health, pleasure and social life.
Still, the strengthening of ties with the multidisciplinary team, with the inclusion of a nutritionist in the systematized diet therapy educational activity, can increase the quality of life of the population under study.
SCIENTIFIC BACKGROUND: In the world, malnutrition in all its forms, including malnutrition, obesity and other dietary risks, for the development of chronic non-communicable diseases (NCDs), corresponds to 19% of the causes of illnesses and premature deaths in everyone. Among the NCDs related to malnutrition, non-alcoholic fatty liver disease (NAFLD) stands out, a syndrome that occurs in non-alcoholic patients, but who present liver damage histologically indistinguishable from alcoholic steatohepatitis.
CASUISTRY Nutritional intervention, when followed correctly, is effective in treating NAFLD in patients who achieve a minimum weight loss of 5% of their baseline body weight after 6 months of dietary therapy. Important alterations in the parameters of insulin resistance and metabolic syndrome are observed in these patients. Even an average reduction of only 2% of the initial body weight (non-adherent group) led to a decrease in some anthropometric parameters, such as BMI and waist circumference, when compared with baseline values. However, patients who lost at least 5% of their initial weight (adherent group) showed more pronounced reductions in these parameters, in addition to improvements in waist-hip ratio, glucose, insulin, HDL-C and LDL-C, alterations not observed in patients non-adherent.
RESEARCH MATERIAL:
For data collection, a form with clinical, dietary and socioeconomic data prepared by the researchers will be used. For the analysis of food intake, a 24-hour recall will be used and the assessment of Nutritional Literacy will be measured using the Nutritional Literacy Scale - NLS - Brazilian version.
PROPOSED METHOD:
Randomized controlled clinical trial with division into two groups (GI and CG) matched 1 to 1. Essentially, it is a study in which participants already seen at the Hepatic Steatosis Outpatient Clinic will be invited to participate and will be randomly allocated (participants are randomized) to receive one or more interventions. Clinical trial results can be directly incorporated into everyday clinical practice. Allocation to the intervention will be performed by simple randomization technique in a 1:1 ratio.
The intervention group will receive individual nutrition education actions with nutrition consultation (in person at the beginning and at 180 days of the intervention and phone calls and text messages at 30, 60, 90, 120 and 150, 240 and 300 days of follow-up. The group The control will receive the usual care at the Outpatient Clinic. The collection of clinical, anthropometric, sociodemographic and food consumption data will be carried out during the nutrition consultations, as well as the application of the NLS-Br Nutritional Literacy questionnaire to verify literacy. During the nutrition consultation A 24-hour recall will be carried out to collect information on food consumption.
They will also be carried out as monthly telephone contacts or messages via instant messaging application, to solve the doubts of the participants and notify them of upcoming meetings, and subsequent comparison of the LN in the target population. All interventions will be recorded in specific instruments for this purpose
EXPECTED OUTCOME It is expected that patients assisted by the nutritionist will have an improvement in the prognosis of non-alcoholic fatty liver disease (NAFLD), reduction in body weight and centripetal adipose mass, modification of lifestyle and increase in nutritional literacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Allocation to the intervention will be performed by simple randomization technique in a 1:1 ratio. The intervention group will receive individual nutrition education actions with nutrition consultation (in person at the beginning and at 180 days of the intervention and phone calls and text messages at 30, 60, 90, 120 and 150, 240 and 300 days of follow-up. The group The control will receive the usual care at the Outpatient Clinic. The collection of clinical, anthropometric, sociodemographic and food consumption data will be carried out during the nutrition consultations, as well as the application of the NLS-Br Nutritional Literacy questionnaire to verify literacy. During the nutrition consultation A 24-hour recall will be carried out to collect information on food consumption.
| Arm | Type | Receives |
|---|---|---|
| Patients will be followed up for one year by nutritionist intervention, on individual goals | Experimental | Behavioral: NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD).Patients allocated in the study will be randomized 1:1 and followed up for one (1) year, intervention group (IG) with nutritionist consultations, nutritional diagnosis and educational intervention with agreement on individual goals. |
| Control Group (CG) will maintain the usual outpatient care. | Active comparator | Behavioral: NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD).Patients in the Control Group (CG) will maintain the usual outpatient care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ambulatory users with a diagnosis of NAFLD in the medical record will be included. For the purposes of eligibility of the patient under study, users must not be significant alcoholics and this questioning, self-reported, is provided for in the nutritionist's consultation protocol. Alcohol consumption is considered significant if defined as > 21 drinks per week in men and > 14 drinks per week in women in a two-year period prior to baseline liver histology.
Key exclusion criteria (1 listed)
- People who are not able to answer the nutritional literacy questionnaire with the help of the researcher will not be included in the research or who, during the research, show accumulation of hepatic fat due to secondary causes, such as the use of steatogenic drugs or hereditary diseases, as well as patients who report frequent alcohol intake. Patients with positive serology for hepatitis B and C, HIV, as well as patients with disabsorptive diseases (Chron's Disease, Celiac Disease), with chronic kidney diseases, who are on the waiting list for bariatric surgery, pregnant and lactating women will also be excluded.
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 |
|---|---|---|
| NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD).The intervention group will receive educational actions in individual nutrition with nutrition consultation (in person at the beginning and at 180 days of the intervention and phone calls and text messages at 30, 60, 90, 120 and 150, 240 and 300 days of follow-up | Behavioural | Control Group (CG) will maintain the usual outpatient care., Patients will be followed up for one year by nutritionist intervention, on individual goals |
Primary outcome
Weight loss of 5% to 10% of body weight, decrease in waist circumference (WC)
Time frame: changes at 180 and 360 days.
The primary clinical outcomes expected for this study are weight loss of 5% to 10% of body weight, decrease in waist circumference (WC), as well as changes in dietary intake pattern, laboratory and anthropometric changes at 180 and 360 days.
1 secondary outcome
Cessation of the progression of NAFLD
Time frame: changes in 180 and 360 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- The Brazilian Registry of Clinical Trials (ReBEC) is a free access virtual platform for recording experimental and non-experimental studies carried out on human beings and conducted in Brazilian territory, by Brazilian and foreign researchers.Link provided by the sponsor.
- Individual participant dataSharing planned: No. In the Informed Consent Form (TCLE), signed by the participants, I affirm that the collected data will not be shared with other studies.
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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.
Maria F Mantovani, Dr principal investigator
Universidade Federal do Paraná
Maria E Schieferdecker, Dr study chair
Universidade Federal do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD). in people with Steatohepatitis, Nonalcoholic and Steatosis, run by Universidade Federal do Paraná at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Jul 2023. 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 Brazil. 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?
Results are not available in the source record.
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?
Weight loss of 5% to 10% of body weight, decrease in waist circumference (WC) (time frame: changes at 180 and 360 days.). 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 19 Jul 2023.