MedTrace Logo

Nutritional Intervention IN Nash NON-ALCOHOLIC (NAFLD).

NCT05946330 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-07-19

No results posted yet for this study

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

Interventions

BEHAVIORAL

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

Sponsors & Collaborators

  • Universidade Federal do Paraná

    lead OTHER

Principal Investigators

  • Maria F Mantovani, Dr · Universidade Federal do Paraná

  • Maria E Schieferdecker, Dr · Universidade Federal do Paraná

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-22
Primary Completion
2023-06-23
Completion
2024-07-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946330 on ClinicalTrials.gov