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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00957814
First received: August 11, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Nutrition
Heart Failure
Behavioral: Nutritional education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Nutritional Orientations on Adherence to Diet and Relation to Nutritional, Clinical and Life Quality Parameters of Heart Failure Outpatients

Resource links provided by NLM:


Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Diet adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knowledge about nutrition, nutritional status, biochemical parameters and life quality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: September 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Nutritional education
    Systematic nutritional orientation program
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Federal University of Rio Grande do Sul /UFRGS, Nutrition Graduation
ClinicalTrials.gov Identifier: NCT00957814     History of Changes
Other Study ID Numbers: UFRGS and HCPA 14741
Study First Received: August 11, 2009
Last Updated: August 11, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:
nutritional education
diet adherence
nutritional knowledge
life quality
nutritional status
impact of nutritional orientations by a systematic education program applied to outpatients with HF, in comparison to patients in a conventional treatment.

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014