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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ingrid Dalira Schweigert, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00957814
First received: August 11, 2009
Last updated: October 25, 2016
Last verified: October 2016
  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
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 Ingrid Dalira Schweigert, Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Diet adherence [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Knowledge about nutrition, nutritional status, biochemical parameters and life quality [ Time Frame: 1 year ]

Enrollment: 46
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Ingrid Dalira Schweigert, Dr., Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT00957814     History of Changes
Other Study ID Numbers: UFRGS and HCPA 14741
Study First Received: August 11, 2009
Last Updated: October 25, 2016

Keywords provided by Ingrid Dalira Schweigert, 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 June 23, 2017