Brazilian Cardioprotective Nutritional Program Trial (BALANCE)

Hospital do Coracao

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Control diet; Behavioral: BALANCE

Study type: Interventional

Funder types: Other

Identifiers

NCT01620398

BCDT

Details and patient eligibility

About

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, The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina.

Full 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 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.

Enrollment: 2,534 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,534 participants in 2 patient groups

BALANCE group

Experimental group

Description:

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.

Treatment:

Behavioral: BALANCE

Control Diet group

Active Comparator group

Description:

generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given.

Treatment:

Behavioral: Control diet