StrokeNCT01517542
Evaluation of Effectiveness of Nutritional Counseling in Patients After Stroke
A study testing Nutritional Counseling in people with Stroke and Cardiovascular Diseases, run by Hospital de Clinicas de Porto Alegre.
Trial summary
Stroke is the leading cause of disability worldwide and the leading cause of death in Brazil. It is estimated that about 18 million people will have a stroke in 2015 and approximately one third of these resulting in death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cardiovascular Diseases
- What is being tested?
- Nutritional Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Sep 2021
- 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
- Ischemic Stroke up to 3 months
- Modified Rankin Score < 4
Who cannot join
- Aphasia
- Enteral diet
- Unavailability to follow up the study
About this study
Official title: Evaluation on the Effectiveness of Nutritional Counseling on an Adapted DASH Diet in Patients After Stroke: a Randomized Clinical Trial
Stroke is the leading cause of disability worldwide and the leading cause of death in Brazil. It is estimated that about 18 million people will have a stroke in 2015 and approximately one third of these resulting in death. The factors most important modifiable risk for stroke include high blood pressure (hypertension), diabetes, smoking, dyslipidemia, sedentary lifestyle and obesity. Acting on these risk factors can be reduced by 88% the risk of another stroke. Healthy eating is among the changes in lifestyle that are recommended for prevention and treatment of one of the main risk factors for stroke. Studies show that the adoption of the DASH diet can significantly reduce blood pressure and the result is even more significant in hypertensive patients, making this diet a new alternative in the prevention and treatment of hypertension and consequently stroke. Compliance therapy is a determining factor for success in the treatment of chronic diseases. Adherence to long-term treatment in developed countries is around 50% and in developing countries the rates are even lower. The aim of this study is to evaluate the effectiveness of nutritional counseling in an adapted DASH style diet on body weight, glycemic control, blood pressure values and improved lipid profile compared to the usual diet without nutritional counseling in patients with stroke within the last 3 months. The hypothesis is that nutritional counseling with an adapted DASH style diet reduces cardiovascular risk factors compared with the usual diet without nutritional counseling in patients with stroke within 3 months. The stroke patients will be selected in the hospitalization or in the outpatient clinic of Hospital de Clínicas de Porto Alegre in a period up to 3 months after ischemic stroke. The patients will be randomized to one of the 2 groups. In the first visit they will be submitted to a social class and international physical activity questionnaire and they will be submitted to a food frequency questionnaire, measures of weight, height, waist circumference, hip and neck, blood pressure and cholesterol and glucose measurements at the baseline, 30 days and 3, 6, 9 and 12 months. The main endpoints will be the change in the body weight, blood glucose, blood pressure values and lipid profile.
Read the detailed description
The study will be followed by a evaluation of other endpoints: new stroke, myocardial infarction or cardiovascular death.
- Conditions
- Stroke, Cardiovascular Diseases
- Being tested
- Nutritional Counseling
- Keywords
- diet, DASH, Stroke, Nutritional counseling
- Medical subject headings
- Stroke, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional CounselingOther
Also called adherence, nutrition
2 groups: 1 with nutritional counseling and other with usual diet without nutritional counseling
| Study group | Role | What they receive |
|---|---|---|
| Nutritional counseling | Experimental | It was composed by patients who received specific written orientation to follow the DASH diet recommendations. Calories were calculated with the goal of maintaining body weight and divided into 3 main meals and two to three snacks. Receives: Other: Nutritional Counseling |
| Usual diet | No intervention | It was composed by patients who were stimulated to follow the general orientations of the neurologist or keep their food intake habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline arterial blood pressure and 6 months
The patients will be randomized to one of the 2 groups (with nutritional counseling and no intervention - habitual diet). The main endpoint will be the change in the blood pressure values and adherence to treatment measured in 30 days and 3, 6, 9 and 12 months.
Measured: 30 days and 3, 6, 9 and 12 months
Secondary outcomes (2)
Change in lipids from baseline
The patients will be randomized to one of the 2 groups (with nutritional counseling and no intervention - habitual diet). The secundary endpoint will be the change in the lipid profile and adherence to treatment measured in 30 days and 3, 6, 9 and 12 months.
Measured: 30 days, 3, 6, 9 and 12 months
Change in the body weight
The patients will be randomized to one of the 2 groups (with nutritional counseling and no intervention - habitual diet). The secundary endpoint will be the change in the body weight measured in 30 days and 3, 6, 9 and 12 months.
Measured: 30 days and 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startFeb 2010
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: low availability of professionals to recruit the participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHEILA CRISTINA OURIQUES MARTINS, Hospital de Clinicas de Porto Alegre
- Investigators
- Sheila CO Martins, PI, Principal investigator, Hospital de Clinicas de Porto AlegreVanessa A Piper, SI, Study director, Hospital de Clinicas de Porto AlegreMárcia LF Chaves, SI, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517542
- Sponsor's protocol ID
- 10-0014
- Status last verified
- Sep 2021
- First submitted
- 22 Nov 2011
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on the Effectiveness of Nutritional Counseling on an Adapted DASH Diet in Patients After Stroke: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01517542
- Acronym / sponsor ID
- 10-0014
- Conditions
- Stroke, Cardiovascular Diseases
- Keywords
- diet, DASH, Stroke, Nutritional counseling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low availability of professionals to recruit the participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 25 Jan 2012 (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.
Stroke is the leading cause of disability worldwide and the leading cause of death in Brazil. It is estimated that about 18 million people will have a stroke in 2015 and approximately one third of these resulting in death. The factors most important modifiable risk for stroke include high blood pressure (hypertension), diabetes, smoking, dyslipidemia, sedentary lifestyle and obesity. Acting on these risk factors can be reduced by 88% the risk of another stroke. Healthy eating is among the changes in lifestyle that are recommended for prevention and treatment of one of the main risk factors for stroke. Studies show that the adoption of the DASH diet can significantly reduce blood pressure and the result is even more significant in hypertensive patients, making this diet a new alternative in the prevention and treatment of hypertension and consequently stroke. Compliance therapy is a determining factor for success in the treatment of chronic diseases. Adherence to long-term treatment in developed countries is around 50% and in developing countries the rates are even lower. The aim of this study is to evaluate the effectiveness of nutritional counseling in an adapted DASH style diet on body weight, glycemic control, blood pressure values and improved lipid profile compared to the usual diet without nutritional counseling in patients with stroke within the last 3 months. The hypothesis is that nutritional counseling with an adapted DASH style diet reduces cardiovascular risk factors compared with the usual diet without nutritional counseling in patients with stroke within 3 months. The stroke patients will be selected in the hospitalization or in the outpatient clinic of Hospital de Clínicas de Porto Alegre in a period up to 3 months after ischemic stroke. The patients will be randomized to one of the 2 groups. In the first visit they will be submitted to a social class and international physical activity questionnaire and they will be submitted to a food frequency questionnaire, measures of weight, height, waist circumference, hip and neck, blood pressure and cholesterol and glucose measurements at the baseline, 30 days and 3, 6, 9 and 12 months. The main endpoints will be the change in the body weight, blood glucose, blood pressure values and lipid profile.
Detailed description
The study will be followed by a evaluation of other endpoints: new stroke, myocardial infarction or cardiovascular death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional counseling | Experimental | Other: Nutritional CounselingIt was composed by patients who received specific written orientation to follow the DASH diet recommendations. Calories were calculated with the goal of maintaining body weight and divided into 3 main meals and two to three snacks. |
| Usual diet | No intervention | –It was composed by patients who were stimulated to follow the general orientations of the neurologist or keep their food intake habits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ischemic Stroke up to 3 months
- Modified Rankin Score < 4
Key exclusion criteria (3 listed)
- Aphasia
- Enteral diet
- Unavailability to follow up the study
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 CounselingAlso: adherence, nutrition2 groups: 1 with nutritional counseling and other with usual diet without nutritional counseling | Other | Nutritional counseling |
Primary outcome
Change from baseline arterial blood pressure and 6 months
Time frame: 30 days and 3, 6, 9 and 12 months
The patients will be randomized to one of the 2 groups (with nutritional counseling and no intervention - habitual diet). The main endpoint will be the change in the blood pressure values and adherence to treatment measured in 30 days and 3, 6, 9 and 12 months.
2 secondary outcomes
Change in lipids from baseline
Time frame: 30 days, 3, 6, 9 and 12 months
Change in the body weight
Time frame: 30 days and 3, 6, 9 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
Sheila CO Martins, PI principal investigator
Hospital de Clinicas de Porto Alegre
Vanessa A Piper, SI study director
Hospital de Clinicas de Porto Alegre
Márcia LF Chaves, SI study chair
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Counseling in people with Stroke and Cardiovascular Diseases, run by Hospital de Clinicas de Porto Alegre.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 16 Sep 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline arterial blood pressure and 6 months (time frame: 30 days and 3, 6, 9 and 12 months). 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 16 Sep 2021.