Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-31 @ 11:21 AM
Study NCT ID:
NCT06376812
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2024-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-01-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Abdominal circumference', 'timeFrame': 'Baseline to 6-months', 'description': 'Change in abdominal circumference (cm)'}, {'measure': 'Abdominal circumference', 'timeFrame': 'Baseline to 12-months', 'description': 'Change in abdominal circumference (cm)'}, {'measure': 'Body mass index', 'timeFrame': 'Baseline to 6-months', 'description': 'Change in body mass index (kg/m2)'}, {'measure': 'Body mass index', 'timeFrame': 'Baseline to 12-months', 'description': 'Change in body mass index (kg/m2)'}], 'primaryOutcomes': [{'measure': 'Days the activity monitor was worn', 'timeFrame': 'Baseline to 6-months', 'description': 'Objectively measured days the wearable activity monitor was worn during the intervention period'}], 'secondaryOutcomes': [{'measure': 'Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months', 'timeFrame': 'Baseline to 6-months', 'description': 'Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period'}, {'measure': 'Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months', 'timeFrame': 'Baseline to 12-months', 'description': 'Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period'}, {'measure': 'Physical activity as measured by minutes of moderate intensity physical activity at 6 months', 'timeFrame': 'Baseline to 6-months', 'description': 'Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period'}, {'measure': 'Physical activity as measured by minutes of moderate intensity physical activity at 6 months', 'timeFrame': 'Baseline to 12-months', 'description': 'Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period'}, {'measure': 'Physical activity as measured by minutes of vigorous intensity physical activity at 6 months', 'timeFrame': 'Baseline to 6-months', 'description': 'Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period'}, {'measure': 'Physical activity as measured by minutes of vigorous intensity physical activity at 6 months', 'timeFrame': 'Baseline to 12-months', 'description': 'Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period'}, {'measure': 'Physical activity as measured by minutes of light intensity physical activity at 6 months', 'timeFrame': 'Baseline to 6-months', 'description': 'Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period'}, {'measure': 'Physical activity as measured by minutes of light intensity physical activity at 6 months', 'timeFrame': 'Baseline to 12-months', 'description': 'Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period'}, {'measure': 'Physical activity as measured by minutes of total physical activity at 6 months', 'timeFrame': 'Baseline to 6-months', 'description': 'Mean daily minutes of total physical activity taken from accelerometers for a 7 day period'}, {'measure': 'Physical activity as measured by minutes of total physical activity at 6 months', 'timeFrame': 'Baseline to 12-months', 'description': 'Mean daily minutes of total physical activity taken from accelerometers for a 7 day period'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'Baseline to 6-months', 'description': 'Change in systolic blood pressure (mmHg)'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'Baseline to 12-months', 'description': 'Change in systolic blood pressure (mmHg)'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'Baseline to 6-months', 'description': 'Change in diastolic blood pressure (mmHg)'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'Baseline to 12-months', 'description': 'Change in diastolic blood pressure (mmHg)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical activity', "Women's health", 'Minority health', 'Behavior change', 'Hypertension prevention'], 'conditions': ['Elevated Blood Pressure', 'Perimenopause']}, 'descriptionModule': {'briefSummary': 'This study will test the effects of a physical activity intervention among midlife Hispanic women.', 'detailedDescription': 'The menopausal transition in midlife is a critical juncture where women experience life transitions and adverse physiological and psychological changes that increase the risk for hypertension and cardiovascular diseases in later life. Physical activity improves blood pressure, biomarkers of hypertension, sleep, mood, and well-being; however, Hispanic women meet physical activity recommendations at lower levels than non-Hispanic White women. The investigator will examine the feasibility of the physical activity intervention among sedentary midlife Hispanic women in the menopausal transition with elevated blood pressure, exploring changes in physical activity and health.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female\n2. Hispanic by self-report\n3. Able to speak and read English\n4. Sedentary\n5. Age 45-50\n6. Diagnosed with elevated blood pressure or objectively measured systolic blood pressure 120-139 mmHg and/or diastolic blood pressure 80-89 mmHg averaged from ≥ 2 measures on ≥ 2 outpatient visits\n7. Symptoms consistent with the menopause transition (persistent difference of ≥7 days in the length of consecutive cycles; persistence is defined as recurrence within 10 cycles of the first variable length cycle)\n8. Apparently healthy\n9. Self-reported ability to engage in moderate intensity physical activity\n10. Access to a smart device that is compatible with a Fitbit application\n\nExclusion Criteria:\n\n1. Self-reported physical activity of ≥150 minutes per week\n2. Answered yes to any question on the Physical Activity Readiness (PAR-Q+) questionnaire\n3. Post-menopausal (12-months without a menstrual cycle)\n4. Diagnosed hypertension\n5. Cardiovascular, respiratory, neurological, renal, endocrine, gastrointestinal and/or psychiatric diseases, or any cancers\n6. Previous hysterectomy, oophorectomy, and/or uterine ablation\n7. Medication to treat hypertension, elevated glucose, cholesterol, depression, anxiety, and insomnia\n8. Hormonal medication via any route or implants\n9. Tamoxifen\n10. Pregnant, planning to become pregnant, or breastfeeding\n11. Planning to move out of the Galveston/Houston area in the next 18 months\n12. Current participation in another physical activity study or program'}, 'identificationModule': {'nctId': 'NCT06376812', 'briefTitle': 'No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'No Time to Pause: Physical Activity to Improve Health and Well-being of Midlife Hispanic Women During the Menopausal Transition', 'orgStudyIdInfo': {'id': '23-0320'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical activity intervention', 'description': 'Multi-level intervention to increase physical activity', 'interventionNames': ['Behavioral: Physical activity intervention']}], 'interventions': [{'name': 'Physical activity intervention', 'type': 'BEHAVIORAL', 'description': 'Physical activity', 'armGroupLabels': ['Physical activity intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Lisa Thibodeaux', 'role': 'CONTACT', 'email': 'lbthibod@utmb.edu'}, {'name': 'Elizabeth Lorenzo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Medical Branch, Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'centralContacts': [{'name': 'Lisa Thibodeaux, BSN, RNC-OB', 'role': 'CONTACT', 'email': 'lbthibod@utmb.edu', 'phone': '409-747-1756'}], 'overallOfficials': [{'name': 'Elizabeth Lorenzo, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'We agree to deposit and/or make available our data upon completion of the clinical trial and acceptance of the data for publication. Data will be stored in the repository for at least 3 years, as required by federal retention guidelines.', 'ipdSharing': 'YES', 'description': 'The research data from this project will be deposited with a service of the Inter-university Consortium for Political and Social Research (ICPSR), openICPSR, to ensure that the research community has long-term access to the data.', 'accessCriteria': 'Data will be shared via openICPSR as open access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}