Viewing Study NCT03421106


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Study NCT ID: NCT03421106
Status: TERMINATED
Last Update Posted: 2023-02-09
First Post: 2018-01-29
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005518', 'term': 'Food Preferences'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'caitlin.caspi@uconn.edu', 'phone': '(860) 486-2834', 'title': 'Caitlin Caspi', 'organization': 'University of Connecticut'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during the period of follow-up for each participant. In Sample A, the mean follow-up was 13.9 months. In Sample B, there was no follow-up and no monitoring of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Food Pantries and Clients', 'description': 'Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured;\n\nIntervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors;\n\nIntervention Clients: Clients who use and were recruited at intervention food pantries.', 'otherNumAtRisk': 158, 'deathsNumAtRisk': 158, 'otherNumAffected': 0, 'seriousNumAtRisk': 158, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Food Pantries and Clients', 'description': 'Food pantries will make no changes during the evaluation period; the effect on clients will be measured;\n\nControl Food Pantries: Normal food pantry operations during the evaluation period;\n\nControl Clients: Clients who use and were recruited at control food pantries.', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 0, 'seriousNumAtRisk': 159, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Diet Quality of Clients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Food Pantries and Clients', 'description': 'Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured;\n\nIntervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors;\n\nIntervention Clients: Clients who use and were recruited at intervention food pantries.'}, {'id': 'OG001', 'title': 'Control Food Pantries and Clients', 'description': 'Food pantries will make no changes during the evaluation period; the effect on clients will be measured;\n\nControl Food Pantries: Normal food pantry operations during the evaluation period;\n\nControl Clients: Clients who use and were recruited at control food pantries.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '1.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.53', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 1 year', 'description': 'Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the best possible score (i.e., nutritional quality best aligned with Dietary Guidelines for Americans)', 'unitOfMeasure': 'Pre-post change in HEI score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 disrupted intervention and post-evaluation activities in 5 sites. The analysis includes participants in Sample A at the 11 completed sites.'}, {'type': 'SECONDARY', 'title': 'Nutritional Quality of Food Selected by Clients at the Food Pantry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Food Pantries and Clients', 'description': 'Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured;\n\nIntervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors;\n\nIntervention Clients: Clients who use and were recruited at intervention food pantries.'}, {'id': 'OG001', 'title': 'Control Food Pantries and Clients', 'description': 'Food pantries will make no changes during the evaluation period; the effect on clients will be measured;\n\nControl Food Pantries: Normal food pantry operations during the evaluation period;\n\nControl Clients: Clients who use and were recruited at control food pantries.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '64.0', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year post-sample comparison', 'description': 'Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the best possible score (i.e., nutritional quality best aligned with Dietary Guidelines for Americans)', 'unitOfMeasure': 'Post-sample HEI score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 disrupted intervention and post-evaluation activities in 5 sites. The analysis includes participants in Sample B at the 11 completed sites.'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Food Pantries and Clients', 'description': 'Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured;\n\nIntervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors;\n\nIntervention Clients: Clients who use and were recruited at intervention food pantries.'}, {'id': 'OG001', 'title': 'Control Food Pantries and Clients', 'description': 'Food pantries will make no changes during the evaluation period; the effect on clients will be measured;\n\nControl Food Pantries: Normal food pantry operations during the evaluation period;\n\nControl Clients: Clients who use and were recruited at control food pantries.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 1 year', 'description': "American Heart Association's Life's Simple 7 (LS7) scores (scale 0 -7), with 7 representing the best possible score for cardiovascular health", 'unitOfMeasure': 'Pre-post change in LS7 score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 disrupted intervention and post-evaluation activities in 5 sites. The analysis includes participants in Sample A at the 11 completed sites.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Food Pantries and Clients', 'description': 'Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured;\n\nIntervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors.\n\nIntervention Clients: Clients who use and were recruited at intervention food pantries.'}, {'id': 'FG001', 'title': 'Control Food Pantries and Clients', 'description': 'Food pantries will make no changes during the evaluation period; the effect on clients will be measured.\n\nControl Food Pantries: Normal food pantry operations during the evaluation period.\n\nControl Clients: Clients who use and were recruited at control food pantries.'}], 'periods': [{'title': 'Sample A (Followed for 1 Year)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '54'}]}]}, {'title': 'Sample B (Evaluated at Post Only)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Two samples of participants were enrolled. The first (Sample A, n=317), had measures collected at two time points. They were enrolled at baseline and followed for one year to assess change in diet quality (primary outcome) and cardiovascular measures (secondary outcome). The second (Sample B, n=187) had measures collected at one time point only. They were enrolled at the pantry during the follow-up period to assess post-intervention client cart diet quality (secondary outcome).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '504', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Food Pantries and Clients', 'description': 'Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured;\n\nIntervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors;\n\nIntervention Clients: Clients who use and were recruited at intervention food pantries.'}, {'id': 'BG001', 'title': 'Control Food Pantries and Clients', 'description': 'Food pantries will make no changes during the evaluation period; the effect on clients will be measured;\n\nControl Food Pantries: Normal food pantry operations during the evaluation period;\n\nControl Clients: Clients who use and were recruited at control food pantries.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than 18 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '504', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '18-64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '504', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}]}, {'title': '65 years and older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '504', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '504', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '498', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '6 total participants did not provide binary sex designations.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '504', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '504', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '504', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-10', 'size': 705235, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-11T10:29', 'hasProtocol': True}, {'date': '2019-02-15', 'size': 212617, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-11-11T10:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 504}}, 'statusModule': {'whyStopped': 'Data collection was halted prematurely due to COVID-19.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2018-01-29', 'resultsFirstSubmitDate': '2021-11-12', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-11', 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Diet Quality of Clients', 'timeFrame': 'Baseline, 1 year', 'description': 'Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the best possible score (i.e., nutritional quality best aligned with Dietary Guidelines for Americans)'}], 'secondaryOutcomes': [{'measure': 'Nutritional Quality of Food Selected by Clients at the Food Pantry', 'timeFrame': '1 year post-sample comparison', 'description': 'Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the best possible score (i.e., nutritional quality best aligned with Dietary Guidelines for Americans)'}, {'measure': 'Cardiovascular Health', 'timeFrame': 'Baseline, 1 year', 'description': "American Heart Association's Life's Simple 7 (LS7) scores (scale 0 -7), with 7 representing the best possible score for cardiovascular health"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food insecurity', 'Food pantries'], 'conditions': ['Food Selection']}, 'referencesModule': {'references': [{'pmid': '35666208', 'type': 'DERIVED', 'citation': 'Caspi C, Gordon N, Bliss Barsness C, Bohen L, Canterbury M, Peterson H, Wolfson J, Pratt R. A randomized study of food pantry environment-level change following the SuperShelf intervention. Transl Behav Med. 2022 Jul 7;12(6):764-774. doi: 10.1093/tbm/ibac003.'}]}, 'descriptionModule': {'briefSummary': 'The investigator proposes an evaluation of a randomized, sustainable intervention in 8 intervention and 8 control pantries. We will enroll a sample clients at the food pantry at baseline and follow them for 1 year to assess changes in overall diet quality (the primary outcome) and cardiovascular health. We will also enroll a sample of clients at follow-up to assess to assess the nutritional quality of food selected at the pantry.', 'detailedDescription': "Evaluate the health impact of an intervention targeting the hunger relief network and the clients with food insecurity it serves. The long-term goal of this work is to reduce nutrition-related health disparities by intervening on a system that serves individuals at high risk for chronic disease. In 2014, an estimated 14% of U.S. households experienced food insecurity (i.e., they lacked access to enough food for an active, healthy life for all household members). Large numbers of low-income, racial/ethnic minority, and immigrant families who experience food insecurity rely on a hunger relief network that includes food banks and food pantries. Pantry clients have demonstrated poor nutritional outcomes, high chronic disease rates, and dissatisfaction with the quality and cultural-appropriateness of food offered. Unlike other food assistance programs, there are currently no standards on the nutritional quality of pantry offerings, but recent work by our study team demonstrated the need to improve the healthfulness of hunger relief network inventory. We proposed an evaluation of a randomized, sustainable intervention in 8 intervention and 8 control pantries. We will enroll clients at baseline and follow them for 1 year to assess changes in overall diet quality (the primary outcome). Working with our food bank partners, the intervention at the pantry level targets the supply of nutritious foods. At the client level, the intervention targets healthy food demand. Measured outcomes include overall diet quality (the primary outcome), as assessed by the Healthy Eating Index-2015 (HEI), the nutritional quality of foods selected at the food shelf visit, and cardiovascular disease health (assessed by the American Heart Association's Life's Simple 7 scores). The study will also evaluate the impact of a multilevel intervention on the nutritional quality of pantry offerings. The study also aims to improve implementation of practices that promote a nutrition-focused hunger relief network."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-≥18 years old\n\n* Mentally capable of consent and participation\n* Speak English, Spanish, or Somali\n* Have access to a phone\n\nExclusion Criteria:\n\n* Not capable of consent or participation\n* Speak only languages other than English, Spanish or Somali\n* Not a food pantry user'}, 'identificationModule': {'nctId': 'NCT03421106', 'acronym': 'SuperShelf', 'briefTitle': 'A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity', 'organization': {'class': 'OTHER', 'fullName': 'University of Connecticut'}, 'officialTitle': 'A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity', 'orgStudyIdInfo': {'id': 'H20-0076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Food Pantries', 'description': 'Food pantries will transform to offer healthier and more appealing food ; the effect on clients will be measured.', 'interventionNames': ['Behavioral: Intervention Food Pantries']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Food Pantries', 'description': 'Food pantries will make no changes during the evaluation period; the effect on clients will be measured.', 'interventionNames': ['Other: Control Food Pantries']}], 'interventions': [{'name': 'Intervention Food Pantries', 'type': 'BEHAVIORAL', 'description': 'Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors.', 'armGroupLabels': ['Intervention Food Pantries']}, {'name': 'Control Food Pantries', 'type': 'OTHER', 'description': 'Normal food pantry use', 'armGroupLabels': ['Control Food Pantries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Caitlin E Caspi, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Connecticut'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Connecticut', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Caitlin Caspi', 'investigatorAffiliation': 'University of Connecticut'}}}}