Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-21 @ 4:08 PM
Study NCT ID:
NCT03969056
Status:
TERMINATED
Last Update Posted:
2023-12-20
First Post:
2019-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI Activity Study in Patients With Elevated Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001185', 'term': 'Artificial Intelligence'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Due to the COVID-19 pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2019-05-20', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in weekly daily average steps', 'timeFrame': 'Baseline (run-in period), 4 week-test period, and 3-month intervention period', 'description': 'measured by ActiGraph GT9X Link\\]'}, {'measure': 'Duration (minutes) of moderate to vigorous intensity physical activity (MVPA) per day', 'timeFrame': 'Baseline (run-in period), 4 week-test period, and 3-month intervention period', 'description': 'measured by ActiGraph GT9X Link\\]'}], 'secondaryOutcomes': [{'measure': 'Changes in Systolic blood pressure (SBP)', 'timeFrame': 'Baseline (run-in period), 4 week-test period, and 3-month intervention period'}, {'measure': 'Changes in diastolic blood pressure (DBP)', 'timeFrame': 'Baseline (run-in period), 4 week-test period, and 3-month intervention period'}, {'measure': 'aortic stiffness', 'timeFrame': 'Baseline (run-in period), 4 week-test period, and 3-month intervention period', 'description': 'measured by SphigmoCor XCEL system'}, {'measure': 'sodium intake', 'timeFrame': 'Baseline (run-in period), 4 week-test period, and 3-month intervention period', 'description': 'as measured in 24-hour urine samples'}, {'measure': 'Changes in weight', 'timeFrame': 'Baseline (run-in period), 4 week-test period, and 3-month intervention period'}, {'measure': 'Changes in Body Mass Index (BMI)', 'timeFrame': 'Baseline (run-in period), 4 week-test period, and 3-month intervention period', 'description': 'using weight and height to calculate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'In this pilot RCT, a total of 40 adults with hypertension will be randomized to either an artificial intelligence (AI) physical activity intervention group or an active control group with a 1 to 1 ratio after completing a 2-week run-in period and 4-week training. The AI intervention group will receive an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning, while the active control group will receive a standardized and fixed 10,000 daily steps goal. Both groups will receive an identical smartphone app (app content differs between the two groups) and ActiGraph GT9X Link to assess objectively measured physical activity (primary outcome) during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* systolic blood pressure between 130 mmHg to 180 mmHg or/and diastolic blood \\*pressure between 80 to 100 mmHg in a research office\n* speaking and reading English\n* being physically inactive at work or during leisure time and willing to be physically active\n* having an iPhone 8 or newer or an Android Lollipop or newer\n\nExclusion Criteria:\n\n* self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes)\n* current participation in a lifestyle modification program or research study\n* self-report of being currently pregnant.'}, 'identificationModule': {'nctId': 'NCT03969056', 'briefTitle': 'AI Activity Study in Patients With Elevated Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Applying Artificial Intelligence to a Physical Activity Intervention in Patients With Elevated Blood Pressure- a Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '18-26452'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Artificial Intelligence (AI) Activity group', 'description': 'Participants in this group receive an AI based intervention (automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning and message)', 'interventionNames': ['Behavioral: Artificial Intelligence (AI) Activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants in this group receive a standardized and fixed 10,000 daily steps goal intervention.', 'interventionNames': ['Behavioral: 10,000 steps']}], 'interventions': [{'name': 'Artificial Intelligence (AI) Activity', 'type': 'BEHAVIORAL', 'description': 'The intervention provides participants with an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning.', 'armGroupLabels': ['Artificial Intelligence (AI) Activity group']}, {'name': '10,000 steps', 'type': 'BEHAVIORAL', 'description': 'The intervention provides participants with an automated daily 10,000 step goal intervention', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Yoshimi Fukuoka, PhD, RN, FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}