Nutritional Education Intervention in Non-Alcoholic Fatty Liver Disease -Nafld
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Weight loss of 5% to 10% of body weight, decrease in waist circumference (WC)
Study Overview
Brief 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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Patients will be followed up for one year by nutritionist intervention, on individual goals
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.
Intervention: NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD). (Behavioral)
Control Group (CG) will maintain the usual outpatient care.
Patients in the Control Group (CG) will maintain the usual outpatient care.
Intervention: NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD). (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Cessation of the progression of NAFLD(changes in 180 and 360 days)
Investigators
Doutorado Enfermagem
Clinical Professor
Universidade Federal do Paraná