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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04114734
Other study ID # R01HL147574
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 27, 2020
Est. completion date July 31, 2025

Study information

Verified date March 2023
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date July 31, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 16 Years
Eligibility Inclusion Criteria: - 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. - ADHD, or - Overweight or obesity, or - hypertriglyceridemia or - hypercholesterolemia, or - pre-diabetes or - Type 2 diabetes. AND - Likely to live in the Washington DC area in the next 2 years. Exclusion Criteria: - Individuals who have previously been given a park prescription

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Park Rx
Participants will be advised to visit a specific park at a specific frequency and duration

Locations

Country Name City State
United States Kaiser Permanente Pasadena California

Sponsors (2)

Lead Sponsor Collaborator
Kaiser Permanente Unity Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in BMI percentile We will review the electronic health record for BMI 2 years
Other Change in Lipids EHR review 2 years
Primary Change in Physical Activity Accelerometer measured Baseline, 3 months, 6 months 12 months and 2 years
Secondary Change in Cognition We will use the NIH toolbox A)The Flanker Inhibitory Control Test; B) Dimensional Change Card Sort Test C) List Sorting Working Memory Test Baseline, 3 months, 6 months 12 months and 2 years
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