Nutritional Intervention IN Nash NON-ALCOHOLIC (NAFLD).

NCT05946330 | Unknown

• 1 other identifier: UFPRENFERMAGEM
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Steatohepatitis, Nonalcoholic; Steatosis; Liver Diseases; Steatohepatitis

Keywords

Adult Health, Health Education; Nutrition Literacy; Nutrition Education,; Non-Alcoholic Fatty Liver Disease (NAFLD)

Outcome Measures

Primary Outcomes (1)

• 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.

  changes at 180 and 360 days.

Secondary Outcomes (1)

• Cessation of the progression of NAFLD

  changes in 180 and 360 days

Study Arms (2)

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.

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.

Behavioral: NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD).

Interventions

NUTRITIONAL EDUCATIONAL INTERVENTION IN FATTY LIVER DISEASE NON-ALCOHOLIC (NAFLD). BEHAVIORAL

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

Control Group (CG) will maintain the usual outpatient care.; Patients will be followed up for one year by nutritionist intervention, on individual goals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Paraná: lead

Study Sites (1)

Hospital de Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, 80060-900, Brazil

Location

Related Links

• 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.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Diseases; Health Education

Condition Hierarchy (Ancestors)

Digestive System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Maria F Mantovani, Dr

  Universidade Federal do Paraná

  PRINCIPAL INVESTIGATOR

• Maria E Schieferdecker, Dr

  Universidade Federal do Paraná

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: February 22, 2023
• Primary Completion: June 23, 2023
• Study Completion: July 31, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)