Overview

This trial is active, not recruiting.

Condition cardiovascular diseases
Treatments balance, cardioprotective diet
Sponsor Hospital do Coracao
Start date February 2012
End date December 2017
Trial size 2100 participants
Trial identifier NCT01620398, BCDT

Summary

There are no studies exploring the benefits of a diet composed of typical Brazilian food in the secondary prevention of cardiovascular diseases. Randomized studies show that the Mediterranean diet is beneficial for patients with established cardiovascular disease or in risk for CVD development. Indeed, nutritional composition of the Mediterranean Diet is one of main references for dietary guidelines for treatment and prevention of CVD in Brazil and the world. However, in many countries, such as Brazil, most foods of the Mediterranean diet are not widely available, may be expensive or are not part of population eating habits. So, the prescription of the Mediterranean diet intervention for cardiovascular disease to the Brazilian population may not be feasible, leading to a low adherence. In this context, patients with established CVD have a low compliance to nutritional prescription. The BALANCE Program, considers 3 concepts: a) A dietary prescription guided by nutritional content recommendations from the Brazilian national guidelines; b) A nutritional education program based on fun, playful strategies and suggestions of affordable foods; and c) Intensive follow-up through one-on-one visits, group sessions, and phone calls. This is the first proposal to use these concepts concurrently with the objective to increase adherence of secondary prevention patients to the diet proposed by the guidelines. Therefore, this trial will investigate the effects of the Program on reducing cardiovascular events - such as cardiac arrest, acute myocardial infarction (AMI), stroke, myocardial revascularization, amputation for peripheral arterial disease, and hospitalization for unstable angina - or death in patients with established CVD. Moreover, it will evaluate the effects of the dietary program on reducing CV factors, such as BMI, waist circumference,

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
balance DICA Br;
(Active Comparator)
generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given.
cardioprotective diet a generalized diet counseling prepared by dietitians based on low fat, low energy, low sodium and low cholesterol diets
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.

Primary Outcomes

Measure
MACE
time frame: 48th month

Secondary Outcomes

Measure
Total cholesterol
time frame: 48 month
LDL
time frame: 48 month
Blood Glucose
time frame: 48 month
Blood pressure
time frame: 48 month
BMI
time frame: 48 month
WC
time frame: 48 month

Eligibility Criteria

Male or female participants at least 45 years old.

Inclusion Criteria: - Any evidence of coronary artery disease (CAD) over the past 10 years, as defined by any of the following criteria: - History of angina (clinical diagnosis, even without exams) - History of stroke - History of abnormal segmental wall motion in cardiac echocardiography (even without symptoms) or a fixed segmental defect in radionuclide imaging test (even if no symptoms) - History of a positive stress test with radionuclide stress test on echocardiography or pharmacologic cardiovascular stress testing demonstrating ischemic heart disease - History of coronary angiography or coronary angiography atherosclerotic stenosis ≥ 50% diameter in any coronary artery - ECG with pathological Q-waves in two contiguous leads. - Any evidence of stroke or TIA in the past 10 years, as defined by any of the following criteria: - Medical diagnosis of stroke or TIA - Evidence of previous stroke - Peripheral Arterial Disease (PAD) in the last 10 years, defined by a diagnosis of current or previous history of any of the following criteria: - Intermittent claudication - amputation - Vascular surgery for atherosclerotic disease - Value ankle/arm <0.90 for systolic blood pressure in either leg at rest - Angiography or Doppler showing> 70% stenosis in an artery noncardiac - Current or previous hospitalization for unstable angina Exclusion Criteria: - Refusal to provide Informed Consent Statement - neurocognitive or psychiatric condition that prevents obtaining reliable clinical data (defined by clinical trial investigators) - Life expectancy less than 6 months - Pregnancy or lactation - Severe hepatic encephalopathy - Renal Failure with indication for dialysis - Congestive heart failure - Patients with organ transplants prior - Wheelchair - Difficulty in receiving oral diet

Additional Information

Official title The Brazilian Cardioprotective Nutritional Program to Reduce Events and Risk Factors in Secondary Prevention for Cardiovascular Disease
Principal investigator Bernardete Berwanger, NC, PhD
Description 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 we aim 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 it is our objective 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. We will randomize 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 cardiovascular death, cardiac arrest, acute myocardial infarction, stroke, and 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. We enrolled 2536 patients in 34 sites. Enrollment was open in March 2013 and ended in March 2015 and patients will be followed up to 48 months.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Hospital do Coracao.