Evaluation of Effectiveness of Nutritional Counseling in Patients After Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
SHEILA CRISTINA OURIQUES MARTINS, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01517542
First received: November 22, 2011
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Stroke
Cardiovascular Diseases
Other: Nutritional Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation on the Effectiveness of Nutritional Counseling on an Adapted DASH Diet in Patients After Stroke: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Change from baseline arterial blood pressure and 6 months [ Time Frame: 30 days and 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days and 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 128
Study Start Date: February 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutritional counseling
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.
Other: Nutritional Counseling
2 groups: 1 with nutritional counseling and other with usual diet without nutritional counseling
Other Names:
  • adherence
  • nutrition
No Intervention: Usual diet
It was composed by patients who were stimulated to follow the general orientations of the neurologist or keep their food intake habits

Detailed Description:

The study will be followed by a evaluation of other endpoints: new stroke, myocardial infarction or cardiovascular death.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic Stroke up to 3 months
  • Modified Rankin Score < 4

Exclusion Criteria:

  • Aphasia
  • Enteral diet
  • Unavailability to follow up the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517542

Contacts
Contact: Sheila CO Martins, PI 555199628467 smartins@portoweb.com
Contact: Vanessa A Piper, SI 555199828748 vanalves001@gmail.com

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035903
Contact: Vanessa A Piper, SI    555199828748    vanalves001@gmail.com   
Contact: Sheila Martins, PI    5199628467    smartins@portoweb.com.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Sheila CO Martins, PI Hospital de Clínicas de Porto Alegre
Study Director: Vanessa A Piper, SI Hospital de Clínicas de Porto Alegre
Study Chair: Márcia LF Chaves, SI Hospital de Clínicas de Porto Alegre
  More Information

No publications provided

Responsible Party: SHEILA CRISTINA OURIQUES MARTINS, Principal Investigator, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01517542     History of Changes
Other Study ID Numbers: 10-0014
Study First Received: November 22, 2011
Last Updated: August 12, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
diet
DASH
Stroke
Nutritional counseling

Additional relevant MeSH terms:
Cardiovascular Diseases
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 19, 2014