Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-06 @ 7:48 AM
Study NCT ID:
NCT04114734
Status:
UNKNOWN
Last Update Posted:
2023-03-13
First Post:
2019-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Park Rx and Physical Activity Among Low-income Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be assigned to get Park Rx or to receive care as usual.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2019-08-27', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in BMI percentile', 'timeFrame': '2 years', 'description': 'We will review the electronic health record for BMI'}, {'measure': 'Change in Lipids', 'timeFrame': '2 years', 'description': 'EHR review'}], 'primaryOutcomes': [{'measure': 'Change in Physical Activity', 'timeFrame': 'Baseline, 3 months, 6 months 12 months and 2 years', 'description': 'Accelerometer measured'}], 'secondaryOutcomes': [{'measure': 'Change in Cognition', 'timeFrame': 'Baseline, 3 months, 6 months 12 months and 2 years', 'description': 'We will use the NIH toolbox A)The Flanker Inhibitory Control Test; B) Dimensional Change Card Sort Test C) List Sorting Working Memory Test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Activity', 'Mental Health Wellness 1']}, 'referencesModule': {'references': [{'pmid': '39592015', 'type': 'DERIVED', 'citation': "Cohen DA, Zarr R, Estrada E, Zhong H, Han B. Association of children's electronic media use with physical activity, cognitive function, and stress. Prev Med. 2025 Jan;190:108184. doi: 10.1016/j.ypmed.2024.108184. Epub 2024 Nov 26."}, {'pmid': '36184966', 'type': 'DERIVED', 'citation': 'Zarr R, Han B, Estrada E, Cohen DA. The Park Rx trial to increase physical activity among low-income youth. Contemp Clin Trials. 2022 Nov;122:106930. doi: 10.1016/j.cct.2022.106930. Epub 2022 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial to evaluate ParkRx, a clinic-based counseling intervention in which health care providers prescribe park visits at a specific frequency, duration, and includes instructions for physical activity in the parks. We will assess whether prescribing visits to specific parks changes physical activity levels and improves health and mental health outcomes among low-income pediatric patients.', 'detailedDescription': "Park prescriptions are formal clinical encouragements for patients to engage in more physical activity outdoors. From the beginning, ParkRx has been perceived as a common-sense solution to physical inactivity and to increasing the time children might be spending outdoors in nature. In spite of a lack of rigorous evidence that it is effective, the ParkRx concept is currently being widely disseminated and has been embraced by multiple national organizations. Unity Health, a federally qualified community health center in Washington, DC, is currently implementing park prescriptions for its largely low-income and minority population, a group at high risk of chronic diseases, physical inactivity and obesity. In partnership with Unity Health, we propose to conduct a randomized controlled trial (RCT) to prospectively evaluate Park Rx's impact on physical activity, as well as other secondary health outcomes in pediatric patients. Our specific aims are: 1) to test whether Park Rx will increase park visits and accelerometry-measured physical activity among children; 2) to identify any biological impacts of Park Rx on health, including impact on hypercholesterolemia, hypertriglyceridemia, HbA1C, overweight and obesity, for those patients with relevant diagnoses; 3) to explore impacts on mental health, including stress and measures of cognitive functioning; and 4) to determine whether there are age and gender differences in adherence to and impact of Park Rx. The results of this study will quantify the effectiveness of Park Rx and inform its future dissemination."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages \\>6 and \\<16 with one or more diagnoses of chronic conditions that usually require two or more routine health care provider visits per year.\n* ADHD, or\n* Overweight or obesity, or\n* hypertriglyceridemia or\n* hypercholesterolemia, or\n* pre-diabetes or\n* Type 2 diabetes. AND\n* Likely to live in the Washington DC area in the next 2 years.\n\nExclusion Criteria:\n\n\\- Individuals who have previously been given a park prescription'}, 'identificationModule': {'nctId': 'NCT04114734', 'acronym': 'ParkRx', 'briefTitle': 'Park Rx and Physical Activity Among Low-income Children', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Park Rx, Physical Activity and Other Health Benefits Among Low-income Children', 'orgStudyIdInfo': {'id': 'R01HL147574', 'link': 'https://reporter.nih.gov/quickSearch/R01HL147574', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Park Rx', 'description': 'Participants will be given a park prescription as part of their treatment plan', 'interventionNames': ['Behavioral: Park Rx']}, {'type': 'NO_INTERVENTION', 'label': 'No Park Rx', 'description': 'Usual care only'}], 'interventions': [{'name': 'Park Rx', 'type': 'BEHAVIORAL', 'description': 'Participants will be advised to visit a specific park at a specific frequency and duration', 'armGroupLabels': ['Park Rx']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91101', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Deborah A Cohen, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'At study completion', 'ipdSharing': 'YES', 'description': 'After the study is completed we will de-identify data and post on the ICSPR website', 'accessCriteria': 'not yet available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unity Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}