Viewing Study NCT04114734


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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: Kaiser Permanente
Organization:

Study Overview

Official Title: Park Rx, Physical Activity and Other Health Benefits Among Low-income Children
Status: UNKNOWN
Status Verified Date: 2023-03
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ParkRx
Brief Summary: 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.
Detailed Description: 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: