Nutritional Orientations and Adherence, Nutritional Statu... | NCT00957814

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

NCT00957814

Sponsor

Federal University of Rio Grande do Sul

Status

Completed

Last Update Posted

Oct 27, 2016Estimated

Enrollment

46Actual

Phase

Not Applicable

Conditions

Nutrition
Heart Failure

Interventions

Nutritional education

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Aug 11, 2009

First Submission Date that Met QC Criteria

Aug 11, 2009

First Posted Date

Aug 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2016

Last Update Posted Date

Oct 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ingrid Dalira Schweigert, Dr., Federal University of Rio Grande do SulPrincipal Investigator

Lead Sponsor

Federal University of Rio Grande do SulOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Conditions Module

Conditions

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Experimental	Usual care with medical and nursing staff	Behavioral: Nutritional education
Intervention	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutritional education	Behavioral	Systematic nutritional orientation program	Control Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diet adherence		1 year

Secondary Outcomes

Measure	Description	Time Frame
Knowledge about nutrition, nutritional status, biochemical parameters and life quality		1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided