{ "FullStudy":{ "Rank":217577, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519583", "OrgStudyIdInfo":{ "OrgStudyId":"PBRC11018" }, "Organization":{ "OrgFullName":"Pennington Biomedical Research Center", "OrgClass":"OTHER" }, "BriefTitle":"WalkMore Walking Interventions for Overweight/Obese Postmenopausal Women", "OfficialTitle":"Title: Comparative Effectiveness of Pedometer-Based Walking Interventions: WalkMore" }, "StatusModule":{ "StatusVerifiedDate":"May 2015", "OverallStatus":"Unknown status", "LastKnownStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2016", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"April 2016", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 4, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 5, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Catrine Tudor-Locke", "ResponsiblePartyInvestigatorTitle":"Principal Invesigator", "ResponsiblePartyInvestigatorAffiliation":"Pennington Biomedical Research Center" }, "LeadSponsor":{ "LeadSponsorName":"Pennington Biomedical Research Center", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"American Heart Association", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The WalkMore study will help find out how walking interventions can help overweight/obese postmenopausal women with increased risk of cardiovascular disease lower their blood pressure.", "DetailedDescription":"Baseline assessment, then a three month intervention or control condition, followed by another assessment at the end of the study. Participants will be screened for blood pressure, height, weight, and the distance around the waist. Participants who meet the eligibility criteria will be given a pedometer to log steps for one week. During visit 2, participants will return the pedometer, and are able to self-monitor appropriately, they will be given an accelerometer to wear for one week.\n\nPedometry:\n\nParticipants will wear a small device which will measure the amount of steps accumulated for 7 days during the first week of the run-in period and again at follow-up (Control group will not perform follow-up pedometry).\n\nAccelerometry:\n\nParticipants will be asked to wear a small device similar to a pedometer attached to a belt at the hip to measure physical activity levels for 7 days during the second week of the run-in period and again at the week prior to follow-up.\n\nAssessment Visits (Baseline and 3 Months):\n\nBlood pressure, brachial ultrasound (measure of the health of the artery), blood draw (fasting blood glucose and insulin), height, body weight, and waist measurement will be measured at the beginning of the main study and again after the 3-month period.\n\nBrachial Artery Ultrasound:\n\nAn ultrasound is a procedure that uses sound waves to create a picture. The brachial artery ultrasound measures how elastic the arteries are and the thickness of the lining of the major blood vessel in the upper arm (the brachial artery). After resting for fifteen minutes, an ultrasound probe will be placed over the brachial artery in the elbow area on the non-dominant arm. A blood pressure cuff will be inflated around the forearm for five minutes to reduce blood flow. When the cuff is deflated, the ultrasound will be continued for five more minutes to observe the blood flowing back into the arm.\n\nBlood Draw:\n\nA fasting blood draw will occur to obtain fasting glucose and insulin.\n\nWalking Gait:\n\nParticipants will walk across a 16 foot computerized floor mat, which will measure walking speed. After a couple practice walks, the participant will be asked to walk 2 times across the mat at 6 different self-selected paces: very slow, slow, preferred/normal, fast, very fast, and as quickly as possible (without running). The participant will be able to rest as needed. The computerized mat will measure walking speed and other elements associated with the pace at which the participant walks." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Postmenopausal Disorder", "Blood Pressure", "Over Weight" ] }, "KeywordList":{ "Keyword":[ "walking", "physical activity", "sedentary behavior" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"120", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Basic Pedometry Intervention", "ArmGroupType":"Experimental", "ArmGroupDescription":"Basic pedometry intervention: Participants will have a goal of obtaining 10,000 steps/day (with no direction with regards to walking intensity/speed/cadence)", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Basic Intervention" ] } },{ "ArmGroupLabel":"Enhanced Pedometry Intervention", "ArmGroupType":"Experimental", "ArmGroupDescription":"Enhanced pedometry Intervention: Participants will have the goal of obtaining 10,000 steps/day and at least 30 minutes in moderate intensity (i.e., at a cadence of at least 100 steps/min);", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Enhanced Pedometry" ] } },{ "ArmGroupLabel":"Control Group", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Control group: Will maintain their usual activity and return for follow-up measures", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Control Group" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Basic Intervention", "InterventionDescription":"Participants will have the goal of obtaining 10,000 steps/day. In addition, participants will attend a meeting once a week with study staff, during which pedometers will be checked, and staff will provide a behavioral intervention to improve physical activity levels", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Basic Pedometry Intervention" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Pedometry" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Enhanced Pedometry", "InterventionDescription":"Intensity Enhanced Pedometry: Participants will have the goal of obtaining 10,000 steps/day at least 30 minutes in moderate intensity (i.e., at a cadence of at least 100 steps/min). In addition, participants will attend a meeting once a week with study staff, during which pedometers will be checked, and the staff will provide a behavioral intervention to improve physical activity levels.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Enhanced Pedometry Intervention" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Control Group", "InterventionDescription":"Maintain usual physical activity, and return for follow-up measures.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Control Group" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "No Pedometry" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Resting systolic blood pressure", "PrimaryOutcomeDescription":"Measured in the seated position using AHA blood pressure measurement guidelines", "PrimaryOutcomeTimeFrame":"3 Months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Resting diastolic blood pressure", "SecondaryOutcomeDescription":"Diastolic blood pressure is measured in the seated position in accordance with AHA guidelines", "SecondaryOutcomeTimeFrame":"3 Months" },{ "SecondaryOutcomeMeasure":"Accelerometry", "SecondaryOutcomeDescription":"An Accelerometry is a device that measures the amount of physical activity.", "SecondaryOutcomeTimeFrame":"3 Months" },{ "SecondaryOutcomeMeasure":"Brachial Ultrasound", "SecondaryOutcomeDescription":"Brachial Ultrasound is a measurement of the health of the artery, which measures the ability of the brachial artery to dilate.", "SecondaryOutcomeTimeFrame":"3 Months" },{ "SecondaryOutcomeMeasure":"Waist Circumference", "SecondaryOutcomeDescription":"Waist Circumference is the distance measured around the waist", "SecondaryOutcomeTimeFrame":"3 Months" },{ "SecondaryOutcomeMeasure":"Walking gait", "SecondaryOutcomeDescription":"Walking gait is evaluated through the use of an electronic mat, which measures walking speed and other elements of gait.", "SecondaryOutcomeTimeFrame":"3 Months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nWoman between 45-74 years of age\nHave not had a menstrual period for at least 12 months\nAre not regularly physically active (self-reported non-exerciser for previous 6 months)\nHave a body mass index (BMI) between 25-45 kg/m2\nHave high normal blood pressure or (systolic pressure of 130-179 mmHg or a diastolic pressure of 85-99 mmHg)\nNot limited in your ability to walk\nUnderstand these criteria\nAre willing to provide informed consent\nWilling to be randomized to either type of walking intervention or a control group being studied, and are willing to follow the protocol for the group to which they have been assigned\n\nExclusion Criteria:\n\nHave a past history and/or physical examination or laboratory findings of a medical condition including (but not limited to):\nHave any medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise\nHave been diagnosed with diabetes\nBlood pressure is greater than 179 mmHg systolic or 99 mmHg diastolic.\nParticipating in another research study which may effect the results of WalkMore", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"45 Years", "MaximumAge":"74 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Catrine Tudor-Locke, PhD", "OverallOfficialAffiliation":"Pennington Biomedical Research Center", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Pennington Biomedical Research Center", "LocationCity":"Baton Rouge", "LocationState":"Louisiana", "LocationZip":"70808", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"24528783", "ReferenceType":"derived", "ReferenceCitation":"Tudor-Locke C, Swift DL, Schuna JM Jr, Dragg AT, Davis AB, Martin CK, Johnson WD, Church TS. WalkMore: a randomized controlled trial of pedometer-based interventions differing on intensity messages. BMC Public Health. 2014 Feb 15;14:168. doi: 10.1186/1471-2458-14-168." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000050177", "ConditionMeshTerm":"Overweight" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001835", "ConditionAncestorTerm":"Body Weight" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M11284", "ConditionBrowseLeafName":"Obesity", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3696", "ConditionBrowseLeafName":"Body Weight", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M24773", "ConditionBrowseLeafName":"Overweight", "ConditionBrowseLeafAsFound":"Over Weight", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }