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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114734
Recruitment Status : Not yet recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Unity Health
Information provided by (Responsible Party):
RAND

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.

Condition or disease Intervention/treatment Phase
Physical Activity Mental Health Wellness 1 Behavioral: Park Rx Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to get Park Rx or to receive care as usual.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Park Rx, Physical Activity and Other Health Benefits Among Low-income Children
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in Physical Activity [ Time Frame: Baseline, 3 months, 6 months 12 months and 2 years ]
    Accelerometer measured


Secondary Outcome Measures :
  1. Change in Cognition [ Time Frame: Baseline, 3 months, 6 months 12 months and 2 years ]
    We will use the NIH toolbox A)The Flanker Inhibitory Control Test; B) Dimensional Change Card Sort Test C) List Sorting Working Memory Test


Other Outcome Measures:
  1. Change in BMI percentile [ Time Frame: 2 years ]
    We will review the electronic health record for BMI

  2. Change in Lipids [ Time Frame: 2 years ]
    EHR review



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114734


Contacts
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Contact: Deborah A Cohen, MD 310 3930411 ext 6023 dcohen@rand.org

Locations
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United States, California
RAND
Santa Monica, California, United States, 90407
Sponsors and Collaborators
RAND
Unity Health

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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT04114734     History of Changes
Other Study ID Numbers: R01HL147574 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study is completed we will de-identify data and post on the ICSPR website
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: At study completion
Access Criteria: not yet available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No