跳至主要内容
临床试验/NCT01517542
NCT01517542撤回不适用

Evaluation on the Effectiveness of Nutritional Counseling on an Adapted DASH Diet in Patients After Stroke: a Randomized Clinical Trial

Hospital de Clinicas de Porto Alegre0 个研究点开始时间: 2010年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Change from baseline arterial blood pressure and 6 months

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •Enteral diet
  • •Unavailability to follow up the study

研究组 & 干预措施

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.

干预措施: Nutritional Counseling (Other)

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

结局指标

主要结局

Change from baseline arterial blood pressure and 6 months

时间窗: 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.

次要结局

  • Change in lipids from baseline(30 days, 3, 6, 9 and 12 months)
  • Change in the body weight(30 days and 3, 6, 9 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SHEILA CRISTINA OURIQUES MARTINS

Principal Investigator

Hospital de Clinicas de Porto Alegre

相似试验