Evaluation of Effectiveness of Nutritional Counseling in Patients After Stroke
Primary Purpose
Stroke, Cardiovascular Diseases
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional Counseling
Sponsored by

About this trial
This is an interventional prevention trial for Stroke focused on measuring diet, DASH, Stroke, Nutritional counseling
Eligibility Criteria
Inclusion Criteria:
- Ischemic Stroke up to 3 months
- Modified Rankin Score < 4
Exclusion Criteria:
- Aphasia
- Enteral diet
- Unavailability to follow up the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutritional counseling
Usual diet
Arm Description
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.
It was composed by patients who were stimulated to follow the general orientations of the neurologist or keep their food intake habits
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01517542
First Posted
November 22, 2011
Last Updated
September 9, 2021
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT01517542
Brief Title
Evaluation of Effectiveness of Nutritional Counseling in Patients After Stroke
Official Title
Evaluation on the Effectiveness of Nutritional Counseling on an Adapted DASH Diet in Patients After Stroke: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
low availability of professionals to recruit the participants
Study Start Date
February 2010 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiovascular Diseases
Keywords
diet, DASH, Stroke, Nutritional counseling
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual diet
Arm Type
No Intervention
Arm Description
It was composed by patients who were stimulated to follow the general orientations of the neurologist or keep their food intake habits
Intervention Type
Other
Intervention Name(s)
Nutritional Counseling
Other Intervention Name(s)
adherence, nutrition
Intervention Description
2 groups: 1 with nutritional counseling and other with usual diet without nutritional counseling
Primary Outcome Measure Information:
Title
Change from baseline arterial blood pressure and 6 months
Description
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.
Time Frame
30 days and 3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
Change in lipids from baseline
Description
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.
Time Frame
30 days, 3, 6, 9 and 12 months
Title
Change in the body weight
Description
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.
Time Frame
30 days and 3, 6, 9 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ischemic Stroke up to 3 months
Modified Rankin Score < 4
Exclusion Criteria:
Aphasia
Enteral diet
Unavailability to follow up the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila CO Martins, PI
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vanessa A Piper, SI
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Márcia LF Chaves, SI
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Effectiveness of Nutritional Counseling in Patients After Stroke
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