Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial
2012年7月16日 更新者：Hospital do Coracao
The Effect of Brazilian Heart Prevent Meal Program Accessible for the Population to Prevent New Cardiovascular Events: A Pilot Randomized Clinical Trial
The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective diet plan to reduce cardiovascular risk factors of new cardiovascular events.
研究概览
地位
完全的
条件
详细说明
Cardiovascular diseases are the leading cause of mortality in both sexes in Brazil and worldwide.
Modifying risk factors such as diet and lifestyle can prevent most cases of cardiovascular disease.
This pilot trial is based on specific and traditional brazilian food.
The objective is to reduce risk factors such as obesity, high blood pressure,dyslipidemia and diabetes in patients with cardiovascular disease history.
研究类型
介入性
注册 (实际的)
122
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Sao Paulo、巴西、04005000
- Hospital do Coracao
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
45年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Any coronary artery disease evidence in the past 10 years; or any ischemic stroke or TIA evidence in the past 10 years; or peripheral arterial disease in the past 10 years; or at least one of the following additional risk factors:
- Diabetes Mellitus; Hypertension; Dyslipidemia; Coronary artery disease family history;
- Asymptomatic carotid artery disease;
- Body mass index> 25 kg/m2 for adults and> 28 kg/m2 for seniors
Exclusion Criteria:
- Neurocognitive or psychiatric condition;
- Life expectancy less than 6 months (eg, metastatic malignancy or other defined as clinical trial investigators).
- Pregnancy or breast feeding.
- Hepatic impairment defined as elevated liver enzymes above three times the upper limit of normal
- Renal impairment defined as creatinine values higher than 1.5 mg/dL.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1
Nutrient profile of the diets used was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases.
Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop.
During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods.
The menus were based on typical foods consumed in Brazil, all foods included in the menu were low-cost and widely available at local markets
|
Nutrient profile of the diets used was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases.
Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop.
During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods.
The menus were based on typical foods consumed in Brazil, all foods included in the menu were low-cost and widely available at local markets
其他名称：
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实验性的：Group 2
Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g.
olive oil and nuts).
The difference between groups B and C was the number of sessions with the dietician.
Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
|
received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g.
olive oil and nuts).
The difference between groups B and C was the number of sessions with the dietician.
Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
其他名称：
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实验性的：Group 3
Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g.
olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician.
That happen monthly in person sessions.
|
received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g.
olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician.
That happen monthly in person sessions.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Systolic Blood Pressure
大体时间：12 weeks
|
Change From Baseline in systolic blood pressure
|
12 weeks
|
|
Total Cholesterol
大体时间：12 weeks
|
Change From Baseline in total Cholesterol
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weight
大体时间：12 weeks
|
Change From Baseline in weight
|
12 weeks
|
|
Waist Circumference
大体时间：12 weeks
|
Change From Baseline in wais circumference
|
12 weeks
|
|
Blood Glucose
大体时间：12 weeks
|
Change From Baseline in blood glucose
|
12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Bernardete Weber, PhD、Hospital do Coracao
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年9月1日
初级完成 (实际的)
2011年12月1日
研究完成 (实际的)
2012年1月1日
研究注册日期
首次提交
2011年10月11日
首先提交符合 QC 标准的
2011年10月13日
首次发布 (估计)
2011年10月17日
研究记录更新
最后更新发布 (估计)
2012年7月19日
上次提交的符合 QC 标准的更新
2012年7月16日
最后验证
2012年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 01/2011
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