Brazilian Cardioprotective Nutritional Program Trial

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, 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.

Conditions

• Cardiovascular Diseases

Interventions

BEHAVIORAL

BALANCE

BEHAVIORAL

Control diet

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.

Sponsors & Collaborators

• Hospital do Coracao

  lead OTHER

Principal Investigators

• Bernardete Berwanger, NC, PhD · Hospital do Coração

• Otávio Berwanger, MD, PhD · Hospital do Coração

• Rafael M Soares, NC, MSc · Hospital do Coração

• Rosana P Costa, NC, MSc · Hospital do Coração

• Maria B Ross-Fernandes, NC, MSc · Hospital do Coração

• Enilda S Lara, NC, PhD · Hopsital do Coração

• Camila R Torreglosa, NC, MSc · Hospital do Coração

• Ângela C Bersch-Ferreira, NC, MSc · Hospital do Coração

• Jacqueline T da Silva, NC · Hospital do Coração

• Andrea P Galante, NC, PhD · Hospital do Coração

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-05

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• Brazil

Study Locations