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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957814
• Other study ID #: UFRGS and HCPA 14741
• Status: Completed
• Phase: N/A
• First received: August 11, 2009
• Last updated: October 25, 2016
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: October 2016
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure
• Nutrition

Intervention

Behavioral:
• Nutritional education
Systematic nutritional orientation program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet adherence		1 year	No
Secondary	Knowledge about nutrition, nutritional status, biochemical parameters and life quality		1 year	No