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

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ClinicalTrials.gov Identifier: NCT00957814
Recruitment Status : Completed
First Posted : August 12, 2009
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Ingrid Dalira Schweigert, Federal University of Rio Grande do Sul

Brief Summary:
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 or disease Intervention/treatment Phase
Nutrition Heart Failure Behavioral: Nutritional education Not Applicable

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  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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



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

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


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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

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
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 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