Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 4:20 AM
Study NCT ID:
NCT01756066
Status:
COMPLETED
Last Update Posted:
2015-12-21
First Post:
2012-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Test of Different Degrees of Cost Sharing on Program Uptake and Attendance
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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1239}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-18', 'studyFirstSubmitDate': '2012-12-19', 'studyFirstSubmitQcDate': '2012-12-19', 'lastUpdatePostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake', 'timeFrame': '12 months', 'description': 'the percent of patients who sign up for the program, by arm'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '12 months', 'description': 'Program attendance and weight loss among participants who sign up for the program'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Weight loss program', 'incentives'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '29277125', 'type': 'DERIVED', 'citation': 'John LK, Troxel AB, Yancy WS Jr, Friedman J, Zhu J, Yang L, Galvin R, Miller-Kovach K, Halpern SD, Loewenstein G, Volpp K. The Effect of Cost Sharing on an Employee Weight Loss Program: A Randomized Trial. Am J Health Promot. 2018 Jan;32(1):170-176. doi: 10.1177/0890117116671282. Epub 2016 Oct 21.'}]}, 'descriptionModule': {'briefSummary': 'To test the uptake of four different cost sharing discounts for enrolling in the Weight Watchers weight loss program as well as outcomes (program attendance and weight loss) over 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must be employee of Vanguard Health Systems over the age of 18\n2. Must have a BMI of 21 or greater\n\nExclusion Criteria:\n\n1. Must not be under the age of 18\n2. Must not have a BMI lower than 21'}, 'identificationModule': {'nctId': 'NCT01756066', 'briefTitle': 'A Test of Different Degrees of Cost Sharing on Program Uptake and Attendance', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Test of Different Degrees of Cost Sharing on Program Uptake and Attendance', 'orgStudyIdInfo': {'id': '816444'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Participant has 50% subsidy, i.e. gets a 50% discount off regular price of the program', 'interventionNames': ['Behavioral: Different levels of cost sharing']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Participant has 100% subsidy, i.e. program attendance is free', 'interventionNames': ['Behavioral: Different levels of cost sharing']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'Participant has 80% subsidy; i.e. gets 80% discount off regular price of the program', 'interventionNames': ['Behavioral: Different levels of cost sharing']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'description': 'Participant has 50% subsidy up front (i.e. pays 50%), with possibility for 100% subsidy based on attaining monthly participation goals', 'interventionNames': ['Behavioral: Different levels of cost sharing']}], 'interventions': [{'name': 'Different levels of cost sharing', 'type': 'BEHAVIORAL', 'armGroupLabels': ['A', 'B', 'C', 'D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28036', 'city': 'Davidson', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Ingersoll Rand', 'geoPoint': {'lat': 35.50233, 'lon': -80.83912}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanguard Health Systems', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Kevin Volpp, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard University', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}