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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Withdrawn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
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring diet, DASH, Stroke, Nutritional counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 22, 2011
    Last Updated
    September 9, 2021
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    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

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    Evaluation of Effectiveness of Nutritional Counseling in Patients After Stroke

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