Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-29 @ 4:21 PM
Study NCT ID:
NCT01167634
Status:
COMPLETED
Last Update Posted:
2017-08-23
First Post:
2010-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
University Of Pennsylvania Weight Loss Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lanorton@mail.med.upenn.edu', 'phone': '2155738799', 'title': 'Laurie Norton', 'phoneExt': '215', 'organization': 'University of Pennsylvania School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data was collected during the intervention period from May 24, 2011 through March 15, 2012.', 'eventGroups': [{'id': 'EG000', 'title': '1 - Control', 'description': 'Control - no financial incentive or match\n\nParticipants are given the goal of losing 1 pound per week for 24 weeks are asked to weigh-in monthly with no financial incentive.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 - Deposit Contract With a 1:1 Match', 'description': 'Deposit contract with a 1:1 match\n\nDeposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3 - Deposit Contract With a 2:1 Match', 'description': 'Deposit contract with a 2:1 match\n\nDeposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Experimental 4 - Deposit Contract With no Match', 'description': 'Deposit contract with no match\n\nDeposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 - Control', 'description': 'Usual care arm'}, {'id': 'OG001', 'title': '2 - Deposit Contract With a 1:1 Match', 'description': 'Deposit contract with a 1:1 match\n\nDeposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.'}, {'id': 'OG002', 'title': '3 - Deposit Contract With a 2:1 Match', 'description': 'Deposit contract with a 2:1 match\n\nDeposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.'}, {'id': 'OG003', 'title': 'Experimental 4 - Deposit With no Match', 'description': 'Deposit contract with no match\n\nDeposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '9.8', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '8.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Weeks', 'description': 'Change in weight between baseline and 24 weeks', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 - Control', 'description': 'Control - no financial incentive or match\n\nParticipants are given the goal of losing 1 pound per week for 24 weeks are asked to weigh-in monthly with no financial incentive.'}, {'id': 'FG001', 'title': '2 - Deposit Contract With a 1:1 Match', 'description': 'Deposit contract with a 1:1 match\n\nDeposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.'}, {'id': 'FG002', 'title': '3 - Deposit Contract With a 2:1 Match', 'description': 'Deposit contract with a 2:1 match\n\nDeposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.'}, {'id': 'FG003', 'title': 'Experimental 4 - Deposit With no Match', 'description': 'Deposit contract with no match\n\nDeposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '1 - Control'}, {'id': 'BG001', 'title': '2 - Deposit Contract With a 1:1 Match', 'description': 'Deposit contract with a 1:1 match\n\nDeposit contract with a 1:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.'}, {'id': 'BG002', 'title': '3 - Deposit Contract With a 2:1 Match', 'description': 'Deposit contract with a 2:1 match\n\nDeposit contract with a 2:1 match: Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.'}, {'id': 'BG003', 'title': 'Experimental 4 - Deposit With no Match', 'description': 'Deposit contract with no match\n\nDeposit Contract with no match: Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '44.3', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '42.0', 'spread': '9.6', 'groupId': 'BG002'}, {'value': '43.5', 'spread': '9.6', 'groupId': 'BG003'}, {'value': '43.9', 'spread': '10.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '115', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-22', 'studyFirstSubmitDate': '2010-07-20', 'resultsFirstSubmitDate': '2017-05-01', 'studyFirstSubmitQcDate': '2010-07-20', 'lastUpdatePostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-22', 'studyFirstPostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Weight', 'timeFrame': '24 Weeks', 'description': 'Change in weight between baseline and 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Weight Loss', 'Motivation', 'Contracts'], 'conditions': ['Weight Loss']}, 'referencesModule': {'references': [{'pmid': '27445325', 'type': 'BACKGROUND', 'citation': "Kullgren JT, Troxel AB, Loewenstein G, Norton LA, Gatto D, Tao Y, Zhu J, Schofield H, Shea JA, Asch DA, Pellathy T, Driggers J, Volpp KG. A Randomized Controlled Trial of Employer Matching of Employees' Monetary Contributions to Deposit Contracts to Promote Weight Loss. Am J Health Promot. 2016 Jul;30(6):441-52. doi: 10.1177/0890117116658210."}]}, 'descriptionModule': {'briefSummary': 'This is a 4-arm, randomized controlled trial to evaluate the effectiveness of financial incentives to motivate and sustain long-term weight loss. The study will recruit eligible employees at a large health management company to participate in a 6-month weight loss program and have weight measurements for an additional 3-month follow-up period. The primary outcome measure in this randomized controlled trial will be pounds of weight lost. The experimental groups will include variations of deposit contracts (participants put their own money at risk, and lose that money if they fail to achieve their weight loss goal) and fixed payments. The use of deposit contracts is a powerful mechanism for inducing behavior change that is based on loss aversion, a psychological concept first described by Nobel Prize winner Daniel Kahneman and Amos Tversky in 1979. A deposit contract takes advantage of the fact that people typically feel the pain of a loss more than the pleasure of a gain, increasing ones motivation to reach a goal.\n\nThe study hypotheses are 1) mean weight loss will be greater in all intervention groups compared to the control group by the end of 24 weeks; and 2) individuals in the intervention groups will have a lower mean weight at the end of the 3-month follow-up period than individuals in the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 70 (inclusive)\n* BMI between 30 and 50 (inclusive)\n\nExclusion Criteria:\n\n* Inability to consent\n* No known Illiteracy and/or inability to speak, read, and write English\n* Participation in another weight loss program\n* Participation in another research study\n* Current treatment for drug or alcohol use\n* Consumption of 5 alcoholic drinks per day\n* Myocardial infarction or stroke within the past 6 months\n* Uncontrolled hypertension (defined as BP170 mm Hg systolic or BP110 mm Hg diastolic)\n* Current addiction to prescription medicines or street drugs\n* Serious psychiatric diagnoses (severe depression, schizophrenia)\n* Pregnancy\n* Diabetic and using any medicine besides metformin to control blood sugars\n* Metastatic cancer\n* Unstable medical conditions that would likely prevent the subject from completing the study\n* Previous diagnosis of an eating disorder\n* History of unsafe weight loss behaviors such as binging or the use of laxatives'}, 'identificationModule': {'nctId': 'NCT01167634', 'briefTitle': 'University Of Pennsylvania Weight Loss Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'University Of Pennsylvania Weight Loss Study', 'orgStudyIdInfo': {'id': '813407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Deposit contract with a 1:1 match', 'interventionNames': ['Behavioral: Deposit contract with a 1:1 match']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Deposit contract with a 2:1 match', 'interventionNames': ['Behavioral: Deposit contract with a 2:1 match']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 4', 'description': 'Deposit contract with no match', 'interventionNames': ['Behavioral: Deposit Contract with no match']}], 'interventions': [{'name': 'Deposit contract with a 1:1 match', 'type': 'BEHAVIORAL', 'description': 'Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.', 'armGroupLabels': ['2']}, {'name': 'Deposit contract with a 2:1 match', 'type': 'BEHAVIORAL', 'description': 'Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.', 'armGroupLabels': ['3']}, {'name': 'Deposit Contract with no match', 'type': 'BEHAVIORAL', 'description': 'Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made.', 'armGroupLabels': ['Experimental 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Kevin G. Volpp, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pennsylvania'}, {'name': 'George Loewenstein, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Carnegie Mellon University'}, {'name': 'Heather Schofield, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Harvard University'}, {'name': 'Jeffrey T Kullgren, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Carnegie Mellon University', 'class': 'OTHER'}, {'name': 'Harvard University', 'class': 'OTHER'}, {'name': 'incentaHEALTH', 'class': 'INDUSTRY'}, {'name': 'McKinsey & Company', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}