NutritionNCT00957814
Nutritional Orientations and Adherence, Nutritional Status, Clinical and Life Quality Parameters of Heart Failure (HF) Patients
A study testing Nutritional education in people with Nutrition and Heart Failure, run by Federal University of Rio Grande do Sul.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition, Heart Failure
- What is being tested?
- Nutritional education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years old
- Outpatients from the HF Ambulatory (HCPA)
- Functional class I and II (NYHA)
Who cannot join
- 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
About this study
Official title: Impact of Nutritional Orientations on Adherence to Diet and Relation to Nutritional, Clinical and Life Quality Parameters of Heart Failure Outpatients
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.
Read the 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
- Nutrition, Heart Failure
- Being tested
- Nutritional education
- 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.
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional educationBehavioural
Systematic nutritional orientation program
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Usual care with medical and nursing staff Receives: 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. Receives: Behavioral: Nutritional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet adherence
Measured: 1 year
Secondary outcomes (1)
Knowledge about nutrition, nutritional status, biochemical parameters and life quality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Dalira Schweigert, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957814
- Sponsor's protocol ID
- UFRGS and HCPA 14741
- Status last verified
- Oct 2016
- First submitted
- 11 Aug 2009
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutritional Orientations on Adherence to Diet and Relation to Nutritional, Clinical and Life Quality Parameters of Heart Failure Outpatients
- ClinicalTrials.gov ID
- NCT00957814
- Acronym / sponsor ID
- UFRGS and HCPA 14741
- 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.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Nutritional educationUsual care with medical and nursing staff |
| Intervention | Experimental | Behavioral: Nutritional educationUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >= 18 years old
- Outpatients from the HF Ambulatory (HCPA)
- Functional class I and II (NYHA)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional educationSystematic nutritional orientation program | Behavioural | Control, Intervention |
Primary outcome
Diet adherence
Time frame: 1 year
1 secondary outcome
Knowledge about nutrition, nutritional status, biochemical parameters and life quality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional education in people with Nutrition and Heart Failure, run by Federal University of Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet adherence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.