MedDataX Logo

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

NCT ID: NCT00957814

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nutrition Heart Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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.

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Usual care with medical and nursing staff

Group Type EXPERIMENTAL

Nutritional education

Intervention Type BEHAVIORAL

Systematic nutritional orientation program

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.

Group Type EXPERIMENTAL

Nutritional education

Intervention Type BEHAVIORAL

Systematic nutritional orientation program

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutritional education

Systematic nutritional orientation program

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ingrid Dalira Schweigert

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UFRGS and HCPA 14741

Identifier Type: -

Identifier Source: org_study_id