Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-20 @ 6:05 PM
Study NCT ID:
NCT02061618
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2014-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Relevant Exercise for Diabetes (CURE-D)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-01', 'studyFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': 'Baseline'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '8-week follow-up', 'description': 'Change from Baseline in Hemoglobin A1c level at 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'Baseline, 8-week follow-up'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline, 8-week follow-up'}, {'measure': 'Physical Activity', 'timeFrame': 'Baseline, 8-week follow-up', 'description': 'Assessed by accelerometers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['South Asian'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '26566446', 'type': 'DERIVED', 'citation': 'Natesan A, Nimbal VC, Ivey SL, Wang EJ, Madsen KA, Palaniappan LP. Engaging South Asian women with type 2 diabetes in a culturally relevant exercise intervention: a randomized controlled trial. BMJ Open Diabetes Res Care. 2015 Oct 28;3(1):e000126. doi: 10.1136/bmjdrc-2015-000126. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The Culturally Relevant Exercise for Diabetes (CURE-D) study will determine whether a culturally-sensitive dance intervention is an accepted and effective physical intervention for South Asian women with type 2 diabetes mellitus. The CURE-D study will determine if Bollywood dance exercise improves diabetes outcomes in South Asian women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: Females\n* Ethnicity: South Asian\n* Hemoglobin A1c ≥ 6.0 mg/dL\n* A PAMF patient for ≥ 24 months\n* Able and willing to enroll and meet the requirements of the study.\n\nExclusion Criteria:\n\n* BMI \\> 35\n* Insulin dependent\n* Current atrial fibrillation\n* Active treatment for cancer\n* Diagnosis of a terminal illness and/or in hospice care\n* Any serious medical condition which would prevent long-term participation or which would contraindicate physical activity\n* Pregnant, lactating, or planning to become pregnant during the study period\n* Inability to speak, read, or understand English\n* No longer a PAMF patient or planning to transfer care outside of PAMF during the study period\n* Investigator discretion for clinical safety or protocol adherence reasons.'}, 'identificationModule': {'nctId': 'NCT02061618', 'acronym': 'CURE-D', 'briefTitle': 'Culturally Relevant Exercise for Diabetes (CURE-D)', 'organization': {'class': 'OTHER', 'fullName': 'Palo Alto Medical Foundation'}, 'officialTitle': 'Culturally Relevant Exercise for Diabetes (CURE-D)', 'orgStudyIdInfo': {'id': '13-07-250'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care'}, {'type': 'EXPERIMENTAL', 'label': 'Bollywood Dance Exercise', 'description': 'Participants in the Bollywood Dance Exercise group will take part in an 8-week dance intervention. The dance classes will take place 2 times per week, approximately 60 minutes per class, for 8 weeks total.', 'interventionNames': ['Behavioral: Bollywood Dance Exercise']}], 'interventions': [{'name': 'Bollywood Dance Exercise', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Bollywood Dance Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation Research Institute', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Palo Alto Medical Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Investigator', 'investigatorFullName': 'Latha Palaniappan, MD, MS', 'investigatorAffiliation': 'Palo Alto Medical Foundation'}}}}