Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT01453166
Status:
COMPLETED
Last Update Posted:
2012-07-19
First Post:
2011-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oberwanger@hcor.com.br', 'phone': '+ 55 11 30536677', 'title': 'Dr. Otavio Berwanger', 'phoneExt': '8201', 'organization': 'Instituto de Ensino e Pesquisa do Hospital do Coração'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "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."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Brazilian Heart-prevent Meal', 'description': 'Nutrient profile of the diets used in the three groups 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, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Heart Prevent Meal I', 'description': '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', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Heart Prevent Meal II', 'description': '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.', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brazilian Heart-prevent Meal', 'description': 'Nutrient profile of the diets used in the three groups 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, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets'}, {'id': 'OG001', 'title': 'Heart Prevent Meal I', 'description': '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'}, {'id': 'OG002', 'title': 'Heart Prevent Meal II', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '127', 'spread': '12', 'groupId': 'OG000', 'lowerLimit': '-18.5', 'upperLimit': '5.2'}, {'value': '129', 'spread': '16', 'groupId': 'OG001', 'lowerLimit': '-6.5', 'upperLimit': '3'}, {'value': '128', 'spread': '13', 'groupId': 'OG002', 'lowerLimit': '-11.9', 'upperLimit': '1.8'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '117', 'spread': '19', 'groupId': 'OG000', 'lowerLimit': '-17.5', 'upperLimit': '-3.4'}, {'value': '126', 'spread': '21', 'groupId': 'OG001', 'lowerLimit': '-10.1', 'upperLimit': '1.8'}, {'value': '123', 'spread': '20', 'groupId': 'OG002', 'lowerLimit': '-8.9', 'upperLimit': '-0.2'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '120', 'ciLowerLimit': '100', 'ciUpperLimit': '140', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19', 'groupDescription': 'The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \\<0.05. All analyzes were performed following the principle of "intention to treat."', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in systolic blood pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were evaluable at this time point were analyzed'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brazilian Heart-prevent Meal', 'description': 'Nutrient profile of the diets used in the three groups 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, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets'}, {'id': 'OG001', 'title': 'Heart Prevent Meal I', 'description': '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'}, {'id': 'OG002', 'title': 'Heart Prevent Meal II', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '82.2', 'spread': '14.9', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1.5'}, {'value': '87.9', 'spread': '15.9', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '-1'}, {'value': '84.3', 'spread': '15.9', 'groupId': 'OG002', 'lowerLimit': '-1.5', 'upperLimit': '-0.3'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '79.3', 'spread': '14.9', 'groupId': 'OG000', 'lowerLimit': '-4.1', 'upperLimit': '-1.7'}, {'value': '85.8', 'spread': '14.5', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '-0.5'}, {'value': '84.0', 'spread': '16.1', 'groupId': 'OG002', 'lowerLimit': '-4', 'upperLimit': '-1.7'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '78', 'ciLowerLimit': '66', 'ciUpperLimit': '95', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in weight', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were evaluable at this time point were analyzed'}, {'type': 'PRIMARY', 'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brazilian Heart-prevent Meal', 'description': 'Nutrient profile of the diets used in the three groups 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, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets'}, {'id': 'OG001', 'title': 'Heart Prevent Meal I', 'description': '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'}, {'id': 'OG002', 'title': 'Heart Prevent Meal II', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '179', 'spread': '40', 'groupId': 'OG000'}, {'value': '169', 'spread': '39', 'groupId': 'OG001'}, {'value': '167', 'spread': '35', 'groupId': 'OG002'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '163', 'spread': '39', 'groupId': 'OG000'}, {'value': '154', 'spread': '41', 'groupId': 'OG001'}, {'value': '148', 'spread': '30', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '170', 'ciLowerLimit': '140', 'ciUpperLimit': '220', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '39', 'groupDescription': 'The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \\<0.05. All analyzes were performed following the principle of "intention to treat."', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in total Cholesterol', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were evaluable at this time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brazilian Heart-prevent Meal', 'description': 'Nutrient profile of the diets used in the three groups 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, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets'}, {'id': 'OG001', 'title': 'Heart Prevent Meal I', 'description': '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'}, {'id': 'OG002', 'title': 'Heart Prevent Meal II', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '102', 'spread': '12', 'groupId': 'OG000'}, {'value': '108', 'spread': '12', 'groupId': 'OG001'}, {'value': '106', 'spread': '11', 'groupId': 'OG002'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '99', 'spread': '12', 'groupId': 'OG000'}, {'value': '105', 'spread': '9', 'groupId': 'OG001'}, {'value': '102', 'spread': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '88', 'ciUpperLimit': '112', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12', 'groupDescription': 'The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \\<0.05. All analyzes were performed following the principle of "intention to treat."', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in wais circumference', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were evaluable at this time point were analyzed'}, {'type': 'SECONDARY', 'title': 'Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brazilian Heart-prevent Meal', 'description': 'Nutrient profile of the diets used in the three groups 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, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets'}, {'id': 'OG001', 'title': 'Heart Prevent Meal I', 'description': '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'}, {'id': 'OG002', 'title': 'Heart Prevent Meal II', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '112', 'spread': '43', 'groupId': 'OG000'}, {'value': '104', 'spread': '22', 'groupId': 'OG001'}, {'value': '108', 'spread': '30', 'groupId': 'OG002'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '107', 'spread': '30', 'groupId': 'OG000'}, {'value': '102', 'spread': '20', 'groupId': 'OG001'}, {'value': '112', 'spread': '26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '77', 'ciUpperLimit': '137', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '30', 'groupDescription': 'The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \\<0.05. All analyzes were performed following the principle of "intention to treat."', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in blood glucose', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were evaluable at this time point were analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brazilian Heart-prevent Meal', 'description': 'Nutrient profile of the diets used in the three groups 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, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets'}, {'id': 'FG001', 'title': 'Heart Prevent Meal I', 'description': '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'}, {'id': 'FG002', 'title': 'Heart Prevent Meal II', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '151 patients agreed to participate of the screening day in the Hospital do Coração in São Paulo Brazil. After eligibility set, From September 2011 to December 2011,122 patients were randomized for one of three treatment groups', 'preAssignmentDetails': 'Of those ineligible, 9 missed the screening day, 14 did not present previews cardiovascular event, 3 declined to participate. After randomization, two patients were identified as ineligible to present chronic renal and hepatic insufficiency, and three dropped out of the study Among those who met inclusion criteria, 117 participants completed study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Brazilian Heart-prevent Meal', 'description': 'Nutrient profile of the diets used in the three groups 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, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets'}, {'id': 'BG001', 'title': 'Heart Prevent Meal I', 'description': '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'}, {'id': 'BG002', 'title': 'Heart Prevent Meal II', 'description': '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.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '7', 'groupId': 'BG000'}, {'value': '65', 'spread': '8', 'groupId': 'BG001'}, {'value': '62', 'spread': '11', 'groupId': 'BG002'}, {'value': '63', 'spread': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-16', 'studyFirstSubmitDate': '2011-10-11', 'resultsFirstSubmitDate': '2012-03-15', 'studyFirstSubmitQcDate': '2011-10-13', 'lastUpdatePostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-13', 'studyFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in systolic blood pressure'}, {'measure': 'Total Cholesterol', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in total Cholesterol'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in weight'}, {'measure': 'Waist Circumference', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in wais circumference'}, {'measure': 'Blood Glucose', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in blood glucose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '23295594', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Cardiovascular diseases are the leading cause of mortality in both sexes in Brazil and worldwide. Modifying risk factors such as diet and lifestyle can prevent most cases of cardiovascular disease. This pilot trial is based on specific and traditional brazilian food. The objective is to reduce risk factors such as obesity, high blood pressure,dyslipidemia and diabetes in patients with cardiovascular disease history.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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:\n* Diabetes Mellitus; Hypertension; Dyslipidemia; Coronary artery disease family history;\n* Asymptomatic carotid artery disease;\n* Body mass index\\> 25 kg/m2 for adults and\\> 28 kg/m2 for seniors\n\nExclusion Criteria:\n\n* Neurocognitive or psychiatric condition;\n* Life expectancy less than 6 months (eg, metastatic malignancy or other defined as clinical trial investigators).\n* Pregnancy or breast feeding.\n* Hepatic impairment defined as elevated liver enzymes above three times the upper limit of normal\n* Renal impairment defined as creatinine values higher than 1.5 mg/dL.'}, 'identificationModule': {'nctId': 'NCT01453166', 'briefTitle': 'Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Coracao'}, 'officialTitle': 'The Effect of Brazilian Heart Prevent Meal Program Accessible for the Population to Prevent New Cardiovascular Events: A Pilot Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '01/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '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', 'interventionNames': ['Other: Brazilian heart-prevent meal']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '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', 'interventionNames': ['Other: Heart prevent control meal weekly']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': '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.', 'interventionNames': ['Other: Heart prevent control Meal monthly']}], 'interventions': [{'name': 'Brazilian heart-prevent meal', 'type': 'OTHER', 'otherNames': ['Dietetic intervation developed by reseachers'], 'description': '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', 'armGroupLabels': ['Group 1']}, {'name': 'Heart prevent control meal weekly', 'type': 'OTHER', 'otherNames': ['Dietetic intervation'], 'description': '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', 'armGroupLabels': ['Group 2']}, {'name': 'Heart prevent control Meal monthly', 'type': 'OTHER', 'otherNames': ['Dietetic intervation once per month'], 'description': '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.', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04005000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital do Coracao', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Bernardete Weber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital do Coração'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Coracao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Brazil', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}