Park Rx and Physical Activity Among Low-income Children | NCT04114734

Studies
Park Rx and Physical Activity Among Low-income Children

NCT04114734

Sponsor

Kaiser Permanente

Status

Unknown status

Last Update Posted

Mar 13, 2023Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Physical Activity
Mental Health Wellness 1

Interventions

Park Rx

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2020Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Jul 31, 2025Estimated

First Submitted Date

Aug 27, 2019

First Submission Date that Met QC Criteria

Oct 1, 2019

First Posted Date

Oct 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2023

Last Update Posted Date

Mar 13, 2023Actual

Name	Class
Unity Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Park Rx	Experimental	Participants will be given a park prescription as part of their treatment plan	Behavioral: Park Rx
No Park Rx	No Intervention	Usual care only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Park Rx	Behavioral	Participants will be advised to visit a specific park at a specific frequency and duration	Park Rx

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deborah A Cohen, MD, MPH	Kaiser Permanente	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permanente		Pasadena	California	91101	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41101405	Derived	Cohen DA, Zarr RL, Estrada EL, Zhong H, Han B. The Park RX RCT: Impact on Physical Activity Among Youth. Am J Prev Med. 2026 Mar;70(3):108154. doi: 10.1016/j.amepre.2025.108154. Epub 2025 Oct 14.
39592015	Derived	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.