Nutritional Orientations and Adherence, Nutritional Status, Clinical and Life Quality Parameters of Heart Failure (HF) Patients

October 25, 2016 updated by: Ingrid Dalira Schweigert, Federal University of Rio Grande do Sul

Impact of Nutritional Orientations on Adherence to Diet and Relation to Nutritional, Clinical and Life Quality Parameters of Heart Failure Outpatients

The nutritional systematic orientations in outpatients with heart failure throughout 1 year in comparison to conventional treatment is estimated to lead to higher nutritional treatment adherence and improved nutritional status, clinical and life quality parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the impact of systematic nutritional orientation on adherence to diet and relation to clinical, life quality and nutritional knowledge parameters in heart failure outpatients.

  • To evaluate the impact of systematic nutritional orientation on nutritional status;
  • To evaluate the impact of nutritional systematic orientation on dietary patterns
  • To evaluate the impact of systematic nutritional orientation on clinical and biochemical parameters
  • To evaluate the impact of nutritional systematic orientation on life quality
  • To evaluate the impact of nutritional systematic orientation on nutritional knowledge

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >= 18 years old
  • Outpatients from the HF Ambulatory (HCPA)
  • Functional class I and II (NYHA)

Exclusion Criteria:

  • Outpatient who had received any orientation from a nutritionist in the last 6 months
  • Outpatients which has not received nursing orientation in the ambulatory,
  • Patients from other NYHA class
  • Non alphabetized

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
Usual care with medical and nursing staff
Behavioral: Nutritional education
Systematic nutritional orientation program
Experimental: Intervention
Usual care with medical and nursing staff and additional nutritional guidance about diet and its relationship with disease, sources of nutrients, and reduction of dietary sodium and fats. Enforcement of the nutritional guidance was performed after 4 weeks.
Behavioral: Nutritional education
Systematic nutritional orientation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diet adherence
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Knowledge about nutrition, nutritional status, biochemical parameters and life quality
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (Estimate)

August 12, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFRGS and HCPA 14741

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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