{ "FullStudy":{ "Rank":217733, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517542", "OrgStudyIdInfo":{ "OrgStudyId":"10-0014" }, "Organization":{ "OrgFullName":"Hospital de Clinicas de Porto Alegre", "OrgClass":"OTHER" }, "BriefTitle":"Evaluation of Effectiveness of Nutritional Counseling in Patients After Stroke", "OfficialTitle":"Evaluation on the Effectiveness of Nutritional Counseling on an Adapted DASH Diet in Patients After Stroke: a Randomized Clinical Trial" }, "StatusModule":{ "StatusVerifiedDate":"August 2014", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2015", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"December 2015", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"November 22, 2011", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 12, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 15, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"SHEILA CRISTINA OURIQUES MARTINS", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"Hospital de Clinicas de Porto Alegre" }, "LeadSponsor":{ "LeadSponsorName":"Hospital de Clinicas de Porto Alegre", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Stroke is the leading cause of disability worldwide and the leading cause of death in Brazil. It is estimated that about 18 million people will have a stroke in 2015 and approximately one third of these resulting in death. The factors most important modifiable risk for stroke include high blood pressure (hypertension), diabetes, smoking, dyslipidemia, sedentary lifestyle and obesity. Acting on these risk factors can be reduced by 88% the risk of another stroke. Healthy eating is among the changes in lifestyle that are recommended for prevention and treatment of one of the main risk factors for stroke. Studies show that the adoption of the DASH diet can significantly reduce blood pressure and the result is even more significant in hypertensive patients, making this diet a new alternative in the prevention and treatment of hypertension and consequently stroke. Compliance therapy is a determining factor for success in the treatment of chronic diseases. Adherence to long-term treatment in developed countries is around 50% and in developing countries the rates are even lower. The aim of this study is to evaluate the effectiveness of nutritional counseling in an adapted DASH style diet on body weight, glycemic control, blood pressure values and improved lipid profile compared to the usual diet without nutritional counseling in patients with stroke within the last 3 months. The hypothesis is that nutritional counseling with an adapted DASH style diet reduces cardiovascular risk factors compared with the usual diet without nutritional counseling in patients with stroke within 3 months. The stroke patients will be selected in the hospitalization or in the outpatient clinic of Hospital de Clínicas de Porto Alegre in a period up to 3 months after ischemic stroke. The patients will be randomized to one of the 2 groups. In the first visit they will be submitted to a social class and international physical activity questionnaire and they will be submitted to a food frequency questionnaire, measures of weight, height, waist circumference, hip and neck, blood pressure and cholesterol and glucose measurements at the baseline, 30 days and 3, 6, 9 and 12 months. The main endpoints will be the change in the body weight, blood glucose, blood pressure values and lipid profile.", "DetailedDescription":"The study will be followed by a evaluation of other endpoints: new stroke, myocardial infarction or cardiovascular death." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Stroke", "Cardiovascular Diseases" ] }, "KeywordList":{ "Keyword":[ "diet", "DASH", "Stroke", "Nutritional counseling" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"128", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Nutritional counseling", "ArmGroupType":"Experimental", "ArmGroupDescription":"It was composed by patients who received specific written orientation to follow the DASH diet recommendations. Calories were calculated with the goal of maintaining body weight and divided into 3 main meals and two to three snacks.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Nutritional Counseling" ] } },{ "ArmGroupLabel":"Usual diet", "ArmGroupType":"No Intervention", "ArmGroupDescription":"It was composed by patients who were stimulated to follow the general orientations of the neurologist or keep their food intake habits" } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"Nutritional Counseling", "InterventionDescription":"2 groups: 1 with nutritional counseling and other with usual diet without nutritional counseling", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Nutritional counseling" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "adherence", "nutrition" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change from baseline arterial blood pressure and 6 months", "PrimaryOutcomeDescription":"The patients will be randomized to one of the 2 groups (with nutritional counseling and no intervention - habitual diet). The main endpoint will be the change in the blood pressure values and adherence to treatment measured in 30 days and 3, 6, 9 and 12 months.", "PrimaryOutcomeTimeFrame":"30 days and 3, 6, 9 and 12 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in lipids from baseline", "SecondaryOutcomeDescription":"The patients will be randomized to one of the 2 groups (with nutritional counseling and no intervention - habitual diet). The secundary endpoint will be the change in the lipid profile and adherence to treatment measured in 30 days and 3, 6, 9 and 12 months.", "SecondaryOutcomeTimeFrame":"30 days, 3, 6, 9 and 12 months" },{ "SecondaryOutcomeMeasure":"Change in the body weight", "SecondaryOutcomeDescription":"The patients will be randomized to one of the 2 groups (with nutritional counseling and no intervention - habitual diet). The secundary endpoint will be the change in the body weight measured in 30 days and 3, 6, 9 and 12 months.", "SecondaryOutcomeTimeFrame":"30 days and 3, 6, 9 and 12 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nIschemic Stroke up to 3 months\nModified Rankin Score < 4\n\nExclusion Criteria:\n\nAphasia\nEnteral diet\nUnavailability to follow up the study", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Sheila CO Martins, PI", "CentralContactRole":"Contact", "CentralContactPhone":"555199628467", "CentralContactEMail":"smartins@portoweb.com" },{ "CentralContactName":"Vanessa A Piper, SI", "CentralContactRole":"Contact", "CentralContactPhone":"555199828748", "CentralContactEMail":"vanalves001@gmail.com" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Sheila CO Martins, PI", "OverallOfficialAffiliation":"Hospital de Clínicas de Porto Alegre", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Vanessa A Piper, SI", "OverallOfficialAffiliation":"Hospital de Clínicas de Porto Alegre", "OverallOfficialRole":"Study Director" },{ "OverallOfficialName":"Márcia LF Chaves, SI", "OverallOfficialAffiliation":"Hospital de Clínicas de Porto Alegre", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Hospital de Clínicas de Porto Alegre", "LocationStatus":"Recruiting", "LocationCity":"Porto Alegre", "LocationState":"RS", "LocationZip":"90035903", "LocationCountry":"Brazil", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Vanessa A Piper, SI", "LocationContactRole":"Contact", "LocationContactPhone":"555199828748", "LocationContactEMail":"vanalves001@gmail.com" },{ "LocationContactName":"Sheila Martins, PI", "LocationContactRole":"Contact", "LocationContactPhone":"5199628467", "LocationContactEMail":"smartins@portoweb.com.br" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000020521", "ConditionMeshTerm":"Stroke" },{ "ConditionMeshId":"D000002318", "ConditionMeshTerm":"Cardiovascular Diseases" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000002561", "ConditionAncestorTerm":"Cerebrovascular Disorders" },{ "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M20890", "ConditionBrowseLeafName":"Stroke", "ConditionBrowseLeafAsFound":"Stroke", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4393", "ConditionBrowseLeafName":"Cerebrovascular Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }