Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT01122420
Status:
COMPLETED
Last Update Posted:
2013-08-22
First Post:
2010-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-21', 'studyFirstSubmitDate': '2010-05-10', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2013-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body mass index', 'timeFrame': 'At enrollment and at 6 months'}, {'measure': 'Change in excess body weight', 'timeFrame': 'At enrollment and at 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether different types of online health tools can aid overweight individuals in reducing their weight and managing their cardiovascular risk factors in the context of an employee wellness program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vanderbilt University employee\n* Completion of the 2009 Go For the Gold Health Risk Assessment (HRA)\n* Obesity defined by BMI \\> 30\n* Identification of an additional risk factor on the HRA by either (a) a personal history of diabetes, high blood pressure, or high cholesterol or (b) a reported cholesterol \\>= 240 mg/dl, blood glucose \\>= 126 mg/dl, a systolic blood pressure \\>= 140 mm Hg, or a diastolic blood pressure \\>= 90 mm Hg\n* Permission to be contacted regarding health on the HRA\n\nExclusion Criteria:\n\n* Pregnant females and those who become pregnant prior to completion of the study\n* Age younger than 18 years or older than 65 years\n* Non English speaking individuals'}, 'identificationModule': {'nctId': 'NCT01122420', 'briefTitle': 'Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program', 'orgStudyIdInfo': {'id': '100021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Goal-Setting Tool', 'interventionNames': ['Other: Goal-Setting Tool']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Web Sites', 'interventionNames': ['Other: Health Web Sites']}], 'interventions': [{'name': 'Goal-Setting Tool', 'type': 'OTHER', 'description': 'Access to an online health-related goal-setting tool through the MyHealthAtVanderbilt patient portal', 'armGroupLabels': ['Goal-Setting Tool']}, {'name': 'Health Web Sites', 'type': 'OTHER', 'description': 'Access to publicly available health-related web sites', 'armGroupLabels': ['Health Web Sites']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Gretchen P Jackson, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Gretchen Purcell Jackson', 'investigatorAffiliation': 'Vanderbilt University'}}}}