Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-17 @ 5:57 PM
Study NCT ID:
NCT06350604
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2024-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project WHADE: A Partner-Based Physical Activity Program for Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-06-23', 'unreleaseDate': '2025-07-02'}, {'resetDate': '2025-07-30', 'releaseDate': '2025-07-15'}], 'estimatedResultsFirstSubmitDate': '2025-06-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D058246', 'term': 'Prehypertension'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants receive the same intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of partner communication', 'timeFrame': 'up to 8 weeks', 'description': 'How frequently each partner dyad communicates with each other between coaching sessions, assessed via self-report in end of day survey (measure created for this study)'}, {'measure': 'Satisfaction with partner communication', 'timeFrame': 'up to 8 weeks', 'description': 'How satisfied each participant is with their partner communication between coaching sessions, assessed via self-report in end of day survey (measure created for this study)'}], 'secondaryOutcomes': [{'measure': 'Physical activity behavior - steps', 'timeFrame': 'up to 8 weeks', 'description': 'Steps per day, assessed with an activity monitor (pedometer with accelerometer)'}, {'measure': 'Physical activity behavior - active minutes', 'timeFrame': 'up to 8 weeks', 'description': 'Minutes of moderate to vigorous activity per day, assessed with an activity monitor (pedometer with accelerometer)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Social support', 'Physical activity'], 'conditions': ['Hypertension', 'Type 2 Diabetes', 'Metabolic Syndrome', 'Smoking', 'High Cholesterol', 'PreDiabetes', 'Prehypertension']}, 'referencesModule': {'references': [{'pmid': '41021523', 'type': 'DERIVED', 'citation': 'Arigo D, Baga K, Folk AL, Haggerty K. Physical activity partners for women with cardiovascular disease risk: Proof-of-concept trial with daily assessment. Health Psychol. 2025 Sep 29:10.1037/hea0001554. doi: 10.1037/hea0001554. Online ahead of print.'}], 'seeAlsoLinks': [{'url': 'https://drarigo.wordpress.com/womens-health-study-project-whade/', 'label': 'Project website'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to test the feasibility and acceptability of a new method for supporting physical activity among women ages 40-65 who have risk factors for cardiovascular disease. Each participant receives a trained physical activity coach and a physical activity partner; the partner is another woman in the program. Partners communicate with each other between weekly coaching sessions to provide support for physical activity behavior change.', 'detailedDescription': 'The purpose of this study is to test the feasibility and acceptability of a new method for supporting physical activity in women ages 40-65 who have risk markers for cardiovascular disease. The primary goal is to understand perceptions of support and communication patterns between partner dyads of women in midlife (ages 40-65). The creation of these partner dyads is a promising method for promoting social support and physical activity for this population. Understanding how partners communicate with one another throughout this intervention study will give insight into how women in this population maximize benefits from partnership through communication and shared experiences (e.g., age, gender, cardiovascular disease risk, interest in being more physically active).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Identification as a woman', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One or more of the following health conditions: smoking (current or quit in the last 3 months), or a physician diagnosis of prediabetes or type 2 diabetes, prehypertension or hypertension (high blood pressure), hypercholesterolemia or hyperlipidemia(high cholesterol), or metabolic syndrome\n* Engaging in less in less than 6500 steps per day or less than 90 minutes of structured exercise per week\n* Access to personal mobile device\n* Fluent in English\n\nExclusion Criteria:\n\n* Pregnant or intend to become pregnant in the next 9 weeks,\n* Medical or psychiatric situation that hinders the ability to perform physical activity\n* None one of the following cardiovascular risk behaviors or conditions: smoking, diagnosed prediabetes/type 2 diabetes, prehypertension/hypertension, high cholesterol, or metabolic syndrome\n* Not fluent in English,\n* No access to a personal mobile device'}, 'identificationModule': {'nctId': 'NCT06350604', 'briefTitle': 'Project WHADE: A Partner-Based Physical Activity Program for Women', 'organization': {'class': 'OTHER', 'fullName': 'Rowan University'}, 'officialTitle': 'Project WHADE: A Partner-Based Physical Activity Program for Women', 'orgStudyIdInfo': {'id': 'PRO-2023-355'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Project WHADE: A Partner-Based Physical Activity Program for Women', 'description': 'Behavioral and cognitive skills to promote physical activity behavior', 'interventionNames': ['Behavioral: Project WHADE: A Partner-Based Physical Activity Program for Women']}], 'interventions': [{'name': 'Project WHADE: A Partner-Based Physical Activity Program for Women', 'type': 'BEHAVIORAL', 'description': 'Combination of behavioral, cognitive, social, and acceptance-based skills training to increase physical activity', 'armGroupLabels': ['Project WHADE: A Partner-Based Physical Activity Program for Women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08028', 'city': 'Glassboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rowan University', 'geoPoint': {'lat': 39.70289, 'lon': -75.11184}}], 'overallOfficials': [{'name': 'Danielle Arigo, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rowan University'}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'To be posted by 6/1 and accessible indefinitely.', 'ipdSharing': 'YES', 'description': 'Protocol and analysis plan will be available via Open Science Framework (osf.io).', 'accessCriteria': 'Public'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rowan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-23', 'type': 'RELEASE'}, {'date': '2025-07-02', 'type': 'UNRELEASE'}, {'date': '2025-07-15', 'type': 'RELEASE'}, {'date': '2025-07-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rowan University'}}}}