Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-09 @ 7:46 AM
Study NCT ID:
NCT03084302
Status:
COMPLETED
Last Update Posted:
2022-10-27
First Post:
2017-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Monitoring Movement and Health Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bbarone@pitt.edu', 'phone': '412-383-4002', 'title': 'Bethany Barone Gibbs, Associate Professor, University of Pittsburgh', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During study participation (6 months)', 'description': 'This study is observational. Only adverse events related to the minimal risk study procedures were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Full Cohort', 'description': 'All participants with at least one valid objective data measure', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Classified as Having High Sedentary Behavior (by Trajectory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'All participants with at least one valid objective data measure'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1st, 2nd, and 3rd trimester of pregnancy', 'description': 'Trajectories identified from objective data across trimesters. High sedentary behavior was defined as the highest group (\\~10.9 hr/day) based on growth mixture models from the objective data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified as Having Low Moderate-to-vigorous Intensity Physical Activity (by Trajectory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'All women with at least one valid assessment of objective activity or sedentary behavior data.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1st, 2nd, and 3rd trimester of pregnancy', 'description': 'Low levels of physical activity across trimesters, identified by growth mixture modelling. The low trajectory corresponded to about 114 minutes per week or about 16 minutes per day.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Excessive Gestational Weight Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'All participants with at least one valid objective data measure'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at delivery', 'description': 'from study visits and medical records excessive gestational weight gain was defined using 2009 Institute of Medicine Guidelines (reference: Institute of Medicine and National Research Council. Weight gain during pregnancy: reexamining the guidelines. Washington, DC: The National Academies Press; 2009)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with at least one valid trimester of objective data and available medical records.'}, {'type': 'SECONDARY', 'title': 'Adverse Pregnancy Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'All participants with at least one valid objective data measure'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during pregnancy', 'description': 'from study visits and medical records includes hypertensive disorders of pregnancy, preterm birth, intrauterine growth restrictions, gestational diabetes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregnant Women', 'description': 'Women in their first trimester of pregnancy, aged 18-45, who plan to receive their prenatal care from University of Pittsburgh Medical Center providers.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Miscarriage, twin pregnancy, congenital abnormality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'No valid objective monitor data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregnant Women', 'description': 'Women in their first trimester of pregnancy, aged 18-45, who plan to receive their prenatal care from University of Pittsburgh Medical Center providers.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants with at least one valid trimester of activity data and without a miscarriage, congenital abnormality, or twin pregnancy.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-04', 'size': 108069, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-18T06:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-25', 'studyFirstSubmitDate': '2017-03-07', 'resultsFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2017-03-13', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-18', 'studyFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Classified as Having High Sedentary Behavior (by Trajectory)', 'timeFrame': '1st, 2nd, and 3rd trimester of pregnancy', 'description': 'Trajectories identified from objective data across trimesters. High sedentary behavior was defined as the highest group (\\~10.9 hr/day) based on growth mixture models from the objective data.'}, {'measure': 'Number of Participants Classified as Having Low Moderate-to-vigorous Intensity Physical Activity (by Trajectory)', 'timeFrame': '1st, 2nd, and 3rd trimester of pregnancy', 'description': 'Low levels of physical activity across trimesters, identified by growth mixture modelling. The low trajectory corresponded to about 114 minutes per week or about 16 minutes per day.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Excessive Gestational Weight Gain', 'timeFrame': 'at delivery', 'description': 'from study visits and medical records excessive gestational weight gain was defined using 2009 Institute of Medicine Guidelines (reference: Institute of Medicine and National Research Council. Weight gain during pregnancy: reexamining the guidelines. Washington, DC: The National Academies Press; 2009)'}, {'measure': 'Adverse Pregnancy Outcomes', 'timeFrame': 'during pregnancy', 'description': 'from study visits and medical records includes hypertensive disorders of pregnancy, preterm birth, intrauterine growth restrictions, gestational diabetes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sedentary behavior', 'physical activity'], 'conditions': ['Pregnancy Related', 'Obesity', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '32046663', 'type': 'BACKGROUND', 'citation': 'Barone Gibbs B, Paley JL, Jones MA, Whitaker KM, Connolly CP, Catov JM. Validity of self-reported and objectively measured sedentary behavior in pregnancy. BMC Pregnancy Childbirth. 2020 Feb 11;20(1):99. doi: 10.1186/s12884-020-2771-z.'}, {'pmid': '33508775', 'type': 'RESULT', 'citation': 'Barone Gibbs B, Jones MA, Jakicic JM, Jeyabalan A, Whitaker KM, Catov JM. Objectively Measured Sedentary Behavior and Physical Activity Across 3 Trimesters of Pregnancy: The Monitoring Movement and Health Study. J Phys Act Health. 2021 Mar 1;18(3):254-261. doi: 10.1123/jpah.2020-0398. Epub 2021 Jan 28.'}, {'pmid': '33124060', 'type': 'RESULT', 'citation': 'Jones MA, Catov JM, Jeyabalan A, Whitaker KM, Barone Gibbs B. Sedentary behaviour and physical activity across pregnancy and birth outcomes. Paediatr Perinat Epidemiol. 2021 May;35(3):341-349. doi: 10.1111/ppe.12731. Epub 2020 Oct 30.'}, {'pmid': '34140419', 'type': 'RESULT', 'citation': 'Jones MA, Whitaker K, Wallace M, Barone Gibbs B. Demographic, Socioeconomic, and Health-Related Predictors of Objectively Measured Sedentary Time and Physical Activity During Pregnancy. J Phys Act Health. 2021 Jun 17;18(8):957-964. doi: 10.1123/jpah.2021-0097. Print 2021 Aug 1.'}, {'pmid': '33715925', 'type': 'RESULT', 'citation': 'Whitaker KM, Zhang D, Kline CE, Catov J, Barone Gibbs B. Associations of Sleep With Sedentary Behavior and Physical Activity Patterns Across Pregnancy Trimesters. Womens Health Issues. 2021 Jul-Aug;31(4):366-375. doi: 10.1016/j.whi.2021.02.003. Epub 2021 Mar 11.'}, {'pmid': '38324012', 'type': 'DERIVED', 'citation': 'Paley JL, Jones MA, Catov JM, Whitaker KM, Kozai AC, Barone Gibbs B. Associations of Physical Activity and Sedentary Behaviors with Depressive Symptoms and Mood Disturbance Throughout Pregnancy. J Womens Health (Larchmt). 2024 Aug;33(8):1128-1138. doi: 10.1089/jwh.2023.0419. Epub 2024 Feb 6.'}, {'pmid': '34969408', 'type': 'DERIVED', 'citation': 'Gibbs BB, Jones MA, Whitaker KM, Ross ST, Davis KK. Measurement of Barriers, Attitudes, and Expectations for Sitting Less in Pregnancy. Am J Health Behav. 2021 Nov 15;45(6):956-970. doi: 10.5993/AJHB.45.6.1.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will study sedentary behavior (SED) across pregnancy in young women. We hypothesize that SED will increase across pregnancy and that higher SED will be related to worse cardiovascular health, specifically elevated blood pressure (BP) and excessive gestational weight gain (GWG). Pregnancy is a biologically relevant period during which CVD risk factors may develop or worsen, contributing to future CVD. Pregnant women also spend most of their day sedentary, which is defined as too much sitting as distinct from too little exercise. SED has emerged as a risk factor, independent from moderate-to-vigorous physical activity (e.g., exercise), for elevated BP, obesity, diabetes, CVD, and mortality in general populations, but there are no recommendations for SED during pregnancy and few studies evaluate SED across pregnancy. These few studies are limited by small sample size, lack of repeated measures across trimesters, suboptimal SED assessment methodology, and a failure to link with clinical outcomes (e.g., BP, GWG). The investigators will address these gaps in a prospective study that will measure SED in 130 pregnant women across three trimesters using state-of-the-art objective activity monitors capable of measuring min-by-min activity by both intensity and posture. We will also measure BP and GWG during each trimester and, further, will link to and abstract all prenatal clinic weights and BPs, glucose screening results, gestational diabetes, preeclampsia, and adverse birth outcomes. Lastly, with the long-term goal of identifying women at high risk of SED during pregnancy and designing effective interventions, the investigators will efficiently evaluate correlates and determinants of SED which have never been studied during pregnancy.', 'detailedDescription': "Objective: The investigators aim to conduct a prospective cohort study using state-of-the-art, noninvasive measurement of sedentary behavior in n=130 pregnant women during each trimester of their first pregnancy. We will link sedentary behavior to gestational weight gain, blood pressure, and potential determinants such as demographics, health conditions and behaviors, psychosocial factors, perceptions/beliefs, and the environment.\n\nSpecific Aims:\n\nAim 1: Objectively measure sedentary behavior across pregnancy trimesters Aim 2: Relate objectively-measured sedentary behavior to blood pressure and gestational weight gain across pregnancy Aim 3: Characterize correlates and determinants of sedentary behavior during pregnancy\n\n1.3 Background: Cardiovacular disease (CVD) remains the leading cause of death in women with minimal declines over the past 30 years among women \\<55 years old. Stagnant rates of CVD mortality in younger women have occurred alongside notable declines in men and older adults and are thought to be due, in part, to high rates of obesity and elevated blood pressure (BP). Related to this, the American Heart Association (AHA) recently identified primordial prevention, a population-level approach that targets preventing rather than treating CVD risk factors, as a necessary strategy to reduce the CVD burden. To achieve primordial prevention, the target must be populations at risk for developing CVD risk factors (vs. those with existing risk factors), such as younger women.\n\nPregnancy is a biologically unique period for young women during which CVD risk factors such as obesity and high blood pressure (BP) can develop or worsen, contributing to future CVD. Pregnant women also spend most of their time in sedentary behavior (SED). SED is any behavior that occurs in a seated/reclining position with low energy expenditure and is now recognized as a behavior that is distinct from inactivity, or a lack of moderate-vigorous physical activity (MVPA). Though MVPA has known benefits, SED is an emerging, independent risk factor for obesity, CVD, and mortality. Importantly, prolonged bouts of SED (accumulated in bouts lasting 30 min or more) in non-pregnant persons are more strongly related to obesity and induce unfavorable hemodynamic responses, such as increased BP. We hypothesize that too much SED across pregnancy is an important contributor to excess gestational weight gain (GWG) and elevated BP, two important CVD risk factors in young women.\n\nRemarkably, a dearth of studies evaluates SED across pregnancy. In cross-sectional studies, pregnant women spend 50-60% of their day in SED and SED is highest in the 3rd trimester. Yet, no study has evaluated if SED increases across pregnancy (repeated measurements) using best practice SED assessment methodology (objective device capable of capturing posture and intensity). Moreover, no study has evaluated whether greater SED is associated with increased GWG and BP in pregnant women, which in turn are known to impact pregnancy health and later maternal CVD risk. Current guidelines only advise MVPA for pregnant women with no recommendations about SED, highlighting the research gaps about SED and its consequences during pregnancy. Moreover, clarifying the role of SED in pregnancy is important because lowering SED might be a feasible strategy for pregnant women, who have low participation in9 and unique barriers to MVPA. Lastly, little is known about correlates and determinants of SED in pregnancy. Such data are critical for identifying women at risk for high SED during pregnancy and for developing effective interventions.\n\n1.4 Significance: Sedentary behavior is a novel risk factor for weight gain, high BP, and CVD, yet patterns, correlates, determinants and consequences of sedentary behavior are poorly understood in pregnant women. Sedentary behavior is the most common behavior in pregnant women, but the dearth of research studies applying state-of-the-art sedentary behavior assessment methods and with repeated measures across pregnancy is a major research gap that we intend to address with this proposal. To the investigators' knowledge, no studies with optimal sedentary behavior measurement, assessing both posture and intensity while awake (i.e., activPAL), have been conducted in pregnant women. Beyond this, few studies have evaluated temporal trends in sedentary time across gestation. There is no research examining bouts of extended, uninterrupted sedentary time which have particularly deleterious effects on BP and are more strongly related to high BMI. Lastly, correlates and determinants of sedentary behavior are poorly understood overall and, in particular, among pregnant women. Before effective interventions can be designed to reduce sedentary behavior in pregnancy, nonmodifiable and modifiable factors associated with sedentary behavior must be better understood. Thus, the objective, longitudinal measurement of sedentary behavior in pregnancy proposed in this application will determine patterns, correlates, determinants, and consequences of sedentary behavior in pregnancy to move toward future goals of 1) clarifying risks and whether sedentary behavior recommendations are appropriate for pregnant women, 2) identifying groups at risk for high sedentary behavior, and 3) informing intervention targets. Further, this research addresses the AHA's mission to reduce the burden of CVD by investigating a novel strategy for primordial prevention of cardiovascular disease in young women."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will recruit 120 women in their first trimester of pregnancy. Women must be 18-45 and must be seeing a UPMC provider for their prenatal care and delivery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 8-12 weeks pregnant\n* 18-45 years old\n* plan to receive prenatal care and deliver with University of Pittsburgh Medical Center providers\n\nExclusion Criteria:\n\n* use of medication to treat diabetes or hypertension\n* medical condition that severely limits physical activity (e.g., cannot walk 2 blocks)\n* other serious medical condition that could affect outcomes (such as systemic lupus, chronic renal disease, or hepatitis)'}, 'identificationModule': {'nctId': 'NCT03084302', 'acronym': 'MoM Health', 'briefTitle': 'Monitoring Movement and Health Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Sedentary Behavior in Pregnancy and Cardiovascular Health: the Monitoring Movement and Health (MoM Health) Study', 'orgStudyIdInfo': {'id': 'PRO16120430'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women', 'description': 'Women in their first trimester of pregnancy, aged 18-45, who plan to receive their prenatal care from University of Pittsburgh Medical Center providers.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Physical Activity and Weight Management Research Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Bethany Barone Gibbs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data requests will be accepted 6 months after the study funding expired (September 2020).', 'ipdSharing': 'YES', 'description': 'Individual participant data will be shared with secondary investigators after the following process. 1) Secondary investigators will submit a proposal to the principal investigator that will be reviewed by all Coinvestigators. 2) If all investigators approve, the secondary investigator will obtain institutional review board approval to conduct the proposed analyses, and 3) a deidentified dataset including only requested variables will be provided to the secondary researcher.', 'accessCriteria': 'Outside investigators wishing to gain access to MoM Health data will be required to submit a document outlining the rationale and hypotheses to be tested, specific data requested, and analytic plan. This will be reviewed by MoM Health Study investigators for rigor and overlap of existing analyses. All reasonable requests will be honored.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Bethany Barone Gibbs', 'investigatorAffiliation': 'University of Pittsburgh'}}}}