The Effect of Brazilian Heart Prevent Meal Program Accessible for the Population to Prevent New Cardiovascular Events: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Brazilian heart-prevent meal (Other)
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
干预措施: Heart prevent control meal weekly (Other)
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.
干预措施: Heart prevent control Meal monthly (Other)
结局指标
主要结局
Systolic Blood Pressure
时间窗: 12 weeks
Change From Baseline in systolic blood pressure
Total Cholesterol
时间窗: 12 weeks
Change From Baseline in total Cholesterol
次要结局
- Weight(12 weeks)
- Waist Circumference(12 weeks)
- Blood Glucose(12 weeks)