Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT01235702
Status:
COMPLETED
Last Update Posted:
2010-11-05
First Post:
2010-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metro Atlanta Heart Disease Study - II (MAHDS II)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-03', 'completionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-04', 'studyFirstSubmitDate': '2010-11-04', 'studyFirstSubmitQcDate': '2010-11-04', 'lastUpdatePostDateStruct': {'date': '2010-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': '10/2002 - 11/2003', 'description': 'a 12-week behavior modification program was implemented to assess the effects of nutrition counseling, stress reduction education, and directed physical activity on African Americans at increased risk for cardiovascular disease.'}], 'secondaryOutcomes': [{'measure': 'body weight', 'timeFrame': '10/2002 - 11/2003'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['high blood pressure, hypertension, African Americans, perceived stress'], 'conditions': ['African Americans With Hypertension.']}, 'descriptionModule': {'briefSummary': 'A 12-week treatment/control trial was implemented to assess the effects of a multi component lifestyle program on improvements in body mass index, weight, perceived stress and blood pressure in African American men and women who were at increased risk for cardiovascular disease. It was hypothesized that treatment group would experience significant improvements when compared to the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: African American men and women aged \\>21 with elevated blood pressure and excess body weight who resided in metro Atlanta, GA.\n\n\\-\n\nExclusion Criteria: Individuals with normal blood pressure and body weight, as well as those residing outside of metro Atlanta, GA. Individuals with psychological conditions were also excluded.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01235702', 'briefTitle': 'Metro Atlanta Heart Disease Study - II (MAHDS II)', 'organization': {'class': 'OTHER', 'fullName': 'Morehouse School of Medicine'}, 'officialTitle': 'Multiple CVD Risk Reduction in Adult African-Americans: A Pilot Study', 'orgStudyIdInfo': {'id': 'TS-0724'}}, 'armsInterventionsModule': {'interventions': [{'name': '12-week lifestyle modification', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30310', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Morehouse School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Sharon K Davis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Morehouse School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morehouse School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sharon K Davis, PhD Director- Social Epidemiology Research Center', 'oldOrganization': 'Morehouse School of Medicine'}}}}