Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT01823458
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2013-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Behavioral Economics Incentives for Health Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2013-03-05', 'studyFirstSubmitQcDate': '2013-03-29', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attendance at exercise classes', 'timeFrame': '12 weeks', 'description': "Attendance at exercise classes over the 12 week session will be analyzed across 'Lottery Insurance' and 'Standard Lottery' arms."}], 'secondaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'Change from Baseline Body Mass Index at 12 weeks', 'description': 'Change from Baseline Body Mass Index (based on Centers for Disease Control calculations) at 12 weeks (post exercise session) will be assessed.'}, {'measure': 'HbA1c', 'timeFrame': 'Change from Baseline HbA1c at 12 weeks', 'description': 'Change from Baseline glycemic control (measured as percentage glycosylated hemoglobin \\[HbA1c\\] as part of a fasting blood sample) at 12 weeks (post exercise session) will be assessed.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Change from Baseline Blood Pressure at 12 weeks', 'description': 'Change from Baseline Blood Pressure at 12 weeks (post exercise session) will be assessed.'}, {'measure': 'LDL cholesterol', 'timeFrame': 'Change from Baseline LDL at 12 weeks', 'description': 'Change from Baseline LDL cholesterol (measured as part of a lipid panel) at 12 weeks (post exercise session) will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['behavioral economics', 'incentives', 'health behavior', 'exercise'], 'conditions': ['Type 2 Diabetes', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Incentives are increasingly being used to motivate health behavior in medical studies. Small cash payments conditional on certain health and welfare promoting behaviors have shown efficacy in both real world and experimental settings. Furthermore, in incentive studies, behavioral economics has been shown to amplify behavior change beyond what is possible with simple cash payments, but little is known about how varying incentive payment design may impact health behavior. The goal of the present study is to evaluate a new incentive payment instrument, lottery insurance, to determine its impact on adherence to the target health behavior, attendance at free exercise classes provided by QueensCare Family Clinics, a safety-net medical clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 64 years of age\n* BMI between 25-40\n* Receiving care in QueensCare Family Clinics\n\nExclusion Criteria:\n\n* Failure to obtain exercise clearance from physician'}, 'identificationModule': {'nctId': 'NCT01823458', 'briefTitle': 'Behavioral Economics Incentives for Health Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Evaluation of Behavioral Economics Patient Incentive Strategies for Health Management', 'orgStudyIdInfo': {'id': 'RC4 AG039115 - 03'}, 'secondaryIdInfos': [{'id': 'RC4AG039115', 'link': 'https://reporter.nih.gov/quickSearch/RC4AG039115', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lottery Insurance', 'description': "All participants receive a one time, $10 payment for attending the first exercise class of the 12 week session. Participants in the 'Lottery Insurance' arm receive a lottery ticket valued at $20 for attending either a Monday or Tuesday exercise class. They have the option to insure their lottery ticket by attending a second exercise class during the week on either Wednesday or Thursday. If they do not attend the second class, they have a 90% chance of winning the weekly lottery. This sequence is repeated each week over the 12 week exercise session.", 'interventionNames': ['Behavioral: Lottery Insurance']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Lottery', 'description': "All participants receive a one time, $10 payment for attending the first exercise class of the 12 week session. Subjects in the 'Standard Lottery' arm receive a lottery ticket valued at $20 for attending either a Monday or Tuesday exercise class. They also receive the expected value of the insurance ($2) for attending a second exercise class during the week on either Wednesday or Thursday. They have a 90% chance of winning the weekly lottery. This sequence is repeated each week over the 12 week exercise session.", 'interventionNames': ['Behavioral: Standard Lottery']}], 'interventions': [{'name': 'Lottery Insurance', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Lottery Insurance']}, {'name': 'Standard Lottery', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Standard Lottery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'QueensCare Family Clinics', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jason N Doctor, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jason Doctor', 'investigatorAffiliation': 'University of Southern California'}}}}