Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05946330 |
| Other study ID # |
UFPRENFERMAGEM |
| Secondary ID |
UFPRENFERMAGEM |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 22, 2023 |
| Est. completion date |
July 31, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Universidade Federal do Paraná |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
