Clinical trial NCT01517542: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Cardiovascular Diseases
Keywords: diet
DASH
Stroke
Nutritional counseling
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change from baseline arterial blood pressure and 6 months
timeFrame: 30 days and 3, 6, 9 and 12 months
Secondary outcomes:
measure: Change in lipids from baseline
timeFrame: 30 days, 3, 6, 9 and 12 months
measure: Change in the body weight
timeFrame: 30 days and 3, 6, 9 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Sheila CO Martins, PI
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Vanessa A Piper, SI
role: STUDY_DIRECTOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Márcia LF Chaves, SI
role: STUDY_CHAIR
References: