Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial

NCT01453166 | Completed Results DMC

• 1 other identifier: 01/2011
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Systolic Blood Pressure

  Change From Baseline in systolic blood pressure

  12 weeks

• Total Cholesterol

  Change From Baseline in total Cholesterol

  12 weeks

Secondary Outcomes (3)

• Weight

  12 weeks

• Waist Circumference

  12 weeks

• Blood Glucose

  12 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

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

Other: Brazilian heart-prevent meal

Group 2

EXPERIMENTAL

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

Other: Heart prevent control meal weekly

Group 3

EXPERIMENTAL

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.

Other: Heart prevent control Meal monthly

Interventions

Brazilian heart-prevent meal OTHER

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

Also known as: Dietetic intervation developed by reseachers

Group 1

Heart prevent control meal weekly OTHER

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

Also known as: Dietetic intervation

Group 2

Heart prevent control Meal monthly OTHER

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.

Also known as: Dietetic intervation once per month

Group 3

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Hospital do Coracao

São Paulo, São Paulo, 04005000, Brazil

Location

Related Publications (1)

• Weber B, Galante AP, Bersch-Ferreira AC, Torreglosa CR, Carvalho VO, Victor Eda S, Espirito-Santo JA, Ross-Fernandes MB, Soares RM, Costa RP, Lara Ede S, Buehler AM, Berwanger O. Effects of Brazilian Cardioprotective Diet Program on risk factors in patients with coronary heart disease: a Brazilian Cardioprotective Diet randomized pilot trial. Clinics (Sao Paulo). 2012 Dec;67(12):1407-14. doi: 10.6061/clinics/2012(12)10.

  PMID: 23295594 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Limitations and Caveats

Small numbers of subjects analyzed, We did not evaluate the patient's adherence to food intake, The high purchasing power of patients, Randomization with opaque envelope technique, Low statistical power.

Results Point of Contact

• Title: Dr. Otavio Berwanger
• Organization: Instituto de Ensino e Pesquisa do Hospital do Coração

oberwanger@hcor.com.br

+ 55 11 30536677

Study Officials

• Bernardete Weber, PhD

  Hospital do Coração

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 17, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: July 19, 2012
• Results First Posted: July 17, 2012

Record last verified: 2012-07

Locations

BR (1)