NCT04114734

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

March 27, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

4.7 years

First QC Date

August 27, 2019

Last Update Submit

March 9, 2023

Conditions

Physical ActivityMental Health Wellness 1

Outcome Measures

Primary Outcomes (1)

  • Change in Physical Activity

    Accelerometer measured

    Baseline, 3 months, 6 months 12 months and 2 years

Secondary Outcomes (1)

  • Change in Cognition

    Baseline, 3 months, 6 months 12 months and 2 years

Other Outcomes (2)

  • Change in BMI percentile

    2 years

  • Change in Lipids

    2 years

Study Arms (2)

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

Park RxBEHAVIORAL

Participants will be advised to visit a specific park at a specific frequency and duration

Park Rx

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Individuals who have previously been given a park prescription

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente

Pasadena, California, 91101, United States

Location

Related Publications (3)

  • Cohen DA, Zarr RL, Estrada EL, Zhong H, Han B. The Park RX RCT: Impact on Physical Activity Among Youth. Am J Prev Med. 2025 Oct 14;70(3):108154. doi: 10.1016/j.amepre.2025.108154. Online ahead of print.

    PMID: 41101405DERIVED

  • 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: 39592015DERIVED

  • 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.

    PMID: 36184966DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Deborah A Cohen, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to get Park Rx or to receive care as usual.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2019

First Posted

October 3, 2019

Study Start

March 27, 2020

Primary Completion

December 1, 2024

Study Completion

July 31, 2025

Last Updated

March 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

After the study is completed we will de-identify data and post on the ICSPR website

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
At study completion
Access Criteria
not yet available

Locations

US(1)