Back to resultsNutritional Orientations and Adherence, Nutritional Status, Clinical and Life Quality Parameters of Heart Failure (HF) Patients
Primary Purpose
Nutrition, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional education
Sponsored by
About this trial
This is an interventional supportive care trial for Nutrition focused on measuring 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.
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control
Intervention
Arm Description
Usual care with medical and nursing staff
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.
Outcomes
Primary Outcome Measures
Diet adherence
Secondary Outcome Measures
Knowledge about nutrition, nutritional status, biochemical parameters and life quality
Full Information
NCT ID
NCT00957814
First Posted
August 11, 2009
Last Updated
October 25, 2016
Sponsor
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT00957814
Brief Title
Nutritional Orientations and Adherence, Nutritional Status, Clinical and Life Quality Parameters of Heart Failure (HF) Patients
Official Title
Impact of Nutritional Orientations on Adherence to Diet and Relation to Nutritional, Clinical and Life Quality Parameters of Heart Failure Outpatients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition, Heart Failure
Keywords
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.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
Usual care with medical and nursing staff
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional education
Intervention Description
Systematic nutritional orientation program
Primary Outcome Measure Information:
Title
Diet adherence
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Knowledge about nutrition, nutritional status, biochemical parameters and life quality
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Nutritional Orientations and Adherence, Nutritional Status, Clinical and Life Quality Parameters of Heart Failure (HF) Patients
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