Brazilian Cardioprotective Nutritional Program Trial
Từ khóa
trừu tượng
Sự miêu tả
The BALANCE Program will investigate the effect of the Program in reducing cardiovascular events, such as cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, hospitalization for unstable angina, or death in patients with established cardiovascular disease. Moreover the aim is to evaluate the effect of the dietary program on reducing cardiovascular risk factors, such as body mass index, waist circumference, blood pressure, total cholesterol, low density lipoprotein (LDL), triglycerides and fasting glucose. Also the objective is to compare the dietary patterns after interventions, the effect of the intervention among nutrients and energy consumption and, finally, to evaluate the BALANCE Program comprehension.
The BALANCE Program is a randomized, multicenter, national trial with allocation concealment and intention-to-treat analysis. The elegibility criteria is patients aged 45 years or more with any evidence of established cardiovascular disease to the BALANCE program or control groups. BALANCE Program is composed by 3 concepts: a) a diet that provides 50-60% of energy from carbohydrate, 10-15% from protein, 25-35% from total fat, <7% from saturated fatty acids, <10% polyunsaturated fatty acids, <20% monounsaturated fatty acids, <1% trans fats, <200 mg/day cholesterol, 20-30 g/day fiber, and <2,400 mg/day sodium; b) Nutrition education program based on ludic strategies and indication of affordable foods; c) An intense follow up by individual and group visits and phone calls. For Control group, generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given. The primary composite outcome is the occurrence of of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease or hospitalization for unstable angina. Blinded assessors will adjudicate clinical events and analysis will follow the intention-to-treat principle. Were enrolled 2534 patients in 35 sites. Enrollment was open in March 2013 and ended in March 2015 and patients will be followed up to 48 months.
ngày
| Xác minh lần cuối: | 04/30/2018 |
| Đệ trình đầu tiên: | 06/12/2012 |
| Đăng ký ước tính đã được gửi: | 06/13/2012 |
| Đăng lần đầu: | 06/14/2012 |
| Cập nhật lần cuối được gửi: | 05/23/2018 |
| Cập nhật lần cuối đã đăng: | 05/28/2018 |
| Ngày bắt đầu nghiên cứu thực tế: | 03/04/2013 |
| Ngày hoàn thành chính ước tính: | 11/30/2017 |
| Ngày hoàn thành nghiên cứu ước tính: | 11/30/2017 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Behavioral: BALANCE group
Behavioral: Control Diet group
Giai đoạn
Nhóm cánh tay
| Cánh tay | Can thiệp / điều trị |
|---|---|
| Experimental: BALANCE group BALANCE Program is composed by 3 concepts: a) a diet composed of 50-60% of energy from carbohydrate, 10-15% of energy from protein; 25-35% of energy from fat (<7% saturated fatty acid; <10% polyunsaturated fatty acid; <20% monounsaturated fatty acid, <1% trans fatty acid), <200 mg/day of cholesterol, 20-30 g/day of fiber and <2400 mg/day of sodium; b) Nutrition education program based on ludic strategies and indication of affordable foods; c) An intense follow up by individual and group visits and phone calls. | Behavioral: BALANCE group |
| Active Comparator: Control Diet group generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given. | Behavioral: Control Diet group Participants will be encourage to follow a generalized diet counseling prepared by dietitians based on low fat, low energy, low sodium and low cholesterol diets. They will receive a common folder composed by lists of foods that should be preferred or avoided. For example, avoidance of ultra processed foods, preference for boiled and baked foods rather than fried foods and recommendation of having at least five meals a day. This folder is equivalent of several that are given on ambulatories or hospital of Brazilian public health. |
Đủ tiêu chuẩn
| Tuổi đủ điều kiện để học | 45 Years Đến 45 Years |
| Giới tính đủ điều kiện để nghiên cứu | All |
| Chấp nhận tình nguyện viên lành mạnh | Đúng |
| Tiêu chí | Inclusion Criteria: - Any evidence of coronary artery disease (CAD) over the preceding 10 years, as defined by any of the following criteria: - defined by previous myocardial infarction, - stable or unstable angina, - history of atherosclerotic stenosis ≥70% of the diameter of any coronary artery on conventional or computed tomographic (CT) coronary angiography, - history of angioplasty, stenting, or coronary artery bypass surgery) - Any evidence of stroke in the preceding 10 years - Peripheral Arterial Disease over the preceding 10 years, as defined by any of the following criteria: - ankle/arm ratio <0.9 of systolic blood pressure in either leg at rest, angiography or Doppler demonstrating >70% stenosis in a cardiac artery, - intermittent claudication, - vascular surgery for atherosclerotic disease, - amputation due to atherosclerotic disease, - aortic aneurysm Exclusion Criteria: - Refusal to provide Informed Consent Statement - neurocognitive or psychiatric condition that may hinder collection of reliable clinical data (defined at the trial investigator's discretion) - Life expectancy less than 6 months - Pregnancy or lactation - Liver failure with a history of encephalopathy or anasarca - Renal Failure with indication for dialysis - Congestive heart failure - Previous organ transplantation - Wheelchair use - Any restrictions to receiving an oral diet. |
Kết quả
Các biện pháp kết quả chính
1. Composity of Major Cardiovascular Events [up to 48 month]
Các biện pháp kết quả thứ cấp
1. Total cholesterol (mg/dl) [up to 48 month]
2. LDL - cholesterol (mg/dl) [up to 48 month]
3. Fasting glucose (mg/dL) [up to 48 month]
4. Blood pressure (mmHg) [up to 48 month]
5. Body-mass index (kg/m2) [up to 48 month]
6. waist circumference (cm) [up to 48 month]
7. Triglycerides (mg/dL) [up to 48 month]
8. isolated occurrence of cardiovascular events [up to 48 month]
9. isolated cardiovascular death or death from any cause [up to 48 month]
10. nutrient and energy intake analysis [up to 48 month]
11. dietary pattern analysis [up to 48 month]
12. BALANCE Program comprehension [up to 48 month]
13. Cost-effectiveness analysis of clinical events (U$/events) [up to 36 month]
14. Cost-effectiveness analysis of diet quality (U$/DQIscore) [up to 36 month]
