Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT07139132
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The AHA Oneida Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092262', 'term': 'Ultrasonography, Carotid Arteries'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in incidence of stroke and transient ischemic attack (TIA)', 'timeFrame': 'Baseline to 1 year', 'description': 'Number of incidences of stroke or TIA during the study'}, {'measure': 'Change in number of participants that meet American Heart Association (AHA) Simple Rules for Diastolic Blood Pressure.', 'timeFrame': 'Baseline to 1 year', 'description': "The AHA's simple rules for diastolic blood pressure: Normal = Less than 80 mm Hg; Elevated = Less than 80 mm Hg with a systolic reading of 120-129 mm Hg; Stage 1 Hypertension = 80-89 mm Hg; Stage 2 Hypertension = 90 mm Hg or higher; Hypertensive Crisis = Higher than 120 mm Hg (along with a systolic reading higher than 180 mm Hg). Researchers will be reporting the change in number of participants with diastolic blood pressure \\<90 mmHg."}, {'measure': "Change in number of participants that meet AHA's Simple Rules for Systolic Blood Pressure.", 'timeFrame': 'Baseline to 1 year', 'description': 'The AHA uses these simple rules for systolic blood pressure (the top number): Normal is less than 120, Elevated is 120-129, Stage 1 Hypertension is 130-139, and Stage 2 Hypertension is 140 or higher. A systolic reading of 180 or higher indicates a hypertensive emergency. Researchers will be reporting the change in number of participants with systolic blood pressure \\<140 mmHg.'}, {'measure': 'Change in number of participants that meet AHA Simple Rules for Body Mass Index (BMI)', 'timeFrame': 'Baseline to 1 year', 'description': 'The AHA uses the following guidelines for Body Mass Index (BMI) in adults:\n\nUnderweight = Less than 18.5; Normal Weight = Between 18.5 and 24.9; Overweight = Between 25 and 29.9; and, Obesity = 30 or higher. Researchers will be reporting any improvement in BMI.'}, {'measure': 'Change in Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Baseline to 1 year', 'description': 'MoCA is scored out of a total of 30 points, with a score of 26 or above generally considered normal. The MoCA assesses various cognitive domains, including memory, visuospatial abilities, language, and executive functions. A lower score indicates potential cognitive impairment, with specific cutoffs for mild (19-23), moderate (10-18), and severe (0-9) impairment.'}, {'measure': 'Change in NIH Toolbox Score', 'timeFrame': 'Baseline to 1 year', 'description': 'NIH Toolbox Cognition Battery consists of tests of multiple constructs to asses for cognitive, sensory, motor and emotional function'}, {'measure': 'Change in Native American Acculturation Scale (NAAS)', 'timeFrame': 'Baseline to 1 year', 'description': 'NAAS is a 20-item questionnaire developed to assess the level of acculturation in Native Americans. It measures an individual\'s connection to both traditional Native American culture and mainstream American culture. Scores range from a low of 1, indicating low acculturation (or high Native American identity) to a high of 5, indicating high acculturation (or high mainstream American identity), with a score of 3 indicating "bicultural". The NAAS examines areas like identity, language, friendships, behaviors, attitudes, and generational/geographic background.'}, {'measure': 'Change in knowledge of health through a structured culturally competent school education programs about nutrition', 'timeFrame': 'Baseline to 1 year'}], 'secondaryOutcomes': [{'measure': 'Change in nutrition knowledge', 'timeFrame': 'Baseline to 1 year', 'description': 'Change in knowledge will be assessed with pre-test, 1 year post-test of each participant to assess improvement in nutritional knowledge and understanding of healthy food options tied to Oneida culture. This will be assessed through a 10-question multiple choice survey about good versus bad nutrition choices. Participants will select their choices, low score indicates poor nutritional knowledge and high score indicating better understanding for healthy nutrition'}, {'measure': 'Change in plaque area', 'timeFrame': 'Baseline to 1 year', 'description': 'Measured via carotid ultrasound.'}, {'measure': 'Change in pulsatility index in carotid arteries', 'timeFrame': 'Baseline to 1 year', 'description': 'Measured via carotid ultrasound. This index is a unitless measurement calculated: peak systolic velocity - end diastolic velocity, divided by the mean velocity, higher values are thought to represent increased resistance to blood flow.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oneida Nation Members']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to learn whether a cultural nutritional program can change stroke risk factors, cognitive decline, and learn how school education programs about nutrition can improve health in the Oneida Nation.\n\nParticipants will undergo:\n\n* A carotid ultrasound\n* Cognitive testing\n* Health assessment\n* Blood work\n* Health wellness coaching\n\nParticipants can expect to be in the study for 1 year.', 'detailedDescription': 'The specific aims for this study are: 1) to determine if a cultural nutritional program across generations can change stroke risk factors in the Oneida Nation; 2) to determine if a cultural nutritional program across generations can change vascular cognitive decline in the Oneida Nation; and, 3) determine how structured culturally competent school education programs about nutrition influence knowledge of health. The intervention used is health wellness coaching. All individuals enrolled in this study will have opportunity to interact with an Oneida Nation employed Health wellness coach to find out about Oneida resources that they can use to modify their stroke risk factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 7-85 years\n* Receiving healthcare though the Oneida Comprehensive Health Division\n\nExclusion Criteria:\n\n* Not Native American'}, 'identificationModule': {'nctId': 'NCT07139132', 'briefTitle': 'The AHA Oneida Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Transforming Risk Factors in a High Stroke Risk Native American Population Through a Cultural Nutritional Program', 'orgStudyIdInfo': {'id': '2025-1171'}, 'secondaryIdInfos': [{'id': 'SMPH/NEURO SURG/NEURO SURG', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'FA', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 10/2/25', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'School-age Native Americans', 'description': 'Participants who are age 7-17 and live with adult parent or guardian will answer a 10 question nutritional knowledge questionnaire.', 'interventionNames': ['Behavioral: Health Wellness Coaching', 'Diagnostic Test: Carotid ultrasound', 'Behavioral: School-age nutritional education program', 'Diagnostic Test: Cognitive Testing']}, {'type': 'EXPERIMENTAL', 'label': 'Adult Native Americans', 'description': 'Adults age 18-85', 'interventionNames': ['Behavioral: Health Wellness Coaching', 'Diagnostic Test: Carotid ultrasound', 'Diagnostic Test: Cognitive Testing', 'Diagnostic Test: Blood work']}], 'interventions': [{'name': 'Health Wellness Coaching', 'type': 'BEHAVIORAL', 'description': 'Health wellness coach will provide education and guidance about cultural nutrition', 'armGroupLabels': ['Adult Native Americans', 'School-age Native Americans']}, {'name': 'Carotid ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will undergo an ultrasound', 'armGroupLabels': ['Adult Native Americans', 'School-age Native Americans']}, {'name': 'School-age nutritional education program', 'type': 'BEHAVIORAL', 'description': 'Educational program will teach students about healthy Native American food choices', 'armGroupLabels': ['School-age Native Americans']}, {'name': 'Cognitive Testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will undergo a cognitive test.', 'armGroupLabels': ['Adult Native Americans', 'School-age Native Americans']}, {'name': 'Blood work', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will undergo blood work.', 'armGroupLabels': ['Adult Native Americans']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Wilbrand, PhD', 'role': 'CONTACT', 'email': 'wilbrand@neurosurgery.wisc.edu', 'phone': '608-265-9248'}, {'name': 'Robert Dempsey, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Wisconsin - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '54155', 'city': 'Oneida', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oneida Nation Reservation', 'geoPoint': {'lat': 44.4986, 'lon': -88.18288}}], 'centralContacts': [{'name': 'Stephanie Wilbrand, PhD', 'role': 'CONTACT', 'email': 'wilbrand@neurosurgery.wisc.edu', 'phone': '608-265-9248'}], 'overallOfficials': [{'name': 'Robert Dempsey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association (AHA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}