Park Rx and Physical Activity Among Low-income Children (ParkRx)

Park Rx, Physical Activity and Other Health Benefits Among Low-income Children

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Activity; Mental Health Wellness 1
• Intervention / Treatment: Behavioral: Park Rx

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91101
      • Kaiser Permanente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Park Rx; Participants will be given a park prescription as part of their treatment plan	Behavioral: Park Rx; Participants will be advised to visit a specific park at a specific frequency and duration
No Intervention: No Park Rx; Usual care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Activity	Accelerometer measured	Baseline, 3 months, 6 months 12 months and 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI percentile	We will review the electronic health record for BMI	2 years
Change in Lipids	EHR review	2 years

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Unity Health
• Investigators: Principal Investigator: Deborah A Cohen, MD, MPH, Kaiser Permanente

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): July 31, 2025

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: R01HL147574 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study is completed we will de-identify data and post on the ICSPR website
• IPD Sharing Time Frame: At study completion
• IPD Sharing Access Criteria: not yet available
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No