Physical ActivityParkRxNCT04114734
Park Rx and Physical Activity Among Low-income Children
A study testing Park Rx in people with Physical Activity and Mental Health Wellness 1, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Physical Activity, Mental Health Wellness 1
- What is being tested?
- Park Rx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2020to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Individuals who have previously been given a park prescription
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity, Mental Health Wellness 1
- Being tested
- Park Rx
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Park RxBehavioural
Participants will be advised to visit a specific park at a specific frequency and duration
| Study group | Role | What they receive |
|---|---|---|
| Park Rx | Experimental | Participants will be given a park prescription as part of their treatment plan Receives: Behavioral: Park Rx |
| No Park Rx | No intervention | Usual care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity
Accelerometer measured
Measured: Baseline, 3 months, 6 months 12 months and 2 years
Secondary outcomes (1)
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
Measured: Baseline, 3 months, 6 months 12 months and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start27 Mar 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to get Park Rx or to receive care as usual.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health
- Responsible party
- Sponsor
- Investigators
- Deborah A Cohen, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114734
- Sponsor's protocol ID
- R01HL147574
- Acronym
- ParkRx
- Status last verified
- Mar 2023
- First submitted
- 27 Aug 2019
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed we will de-identify data and post on the ICSPR website
Publications
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.
PubMed 41101405Cohen 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.
PubMed 39592015Zarr 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.
PubMed 36184966
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Park Rx, Physical Activity and Other Health Benefits Among Low-income Children
- ClinicalTrials.gov ID
- NCT04114734
- Acronym / sponsor ID
- ParkRx / R01HL147574
- Conditions
- Physical Activity, Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Unity Health
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to get Park Rx or to receive care as usual.
| Arm | Type | Receives |
|---|---|---|
| Park Rx | Experimental | Behavioral: Park RxParticipants will be given a park prescription as part of their treatment plan |
| No Park Rx | No intervention | –Usual care only |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals who have previously been given a park prescription
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Park RxParticipants will be advised to visit a specific park at a specific frequency and duration | Behavioural | Park Rx |
Primary outcome
Change in Physical Activity
Time frame: Baseline, 3 months, 6 months 12 months and 2 years
Accelerometer measured
1 secondary outcome
Change in Cognition
Time frame: Baseline, 3 months, 6 months 12 months and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Derived from this study: PubMed 41101405Cohen 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.
- Derived from this study: PubMed 39592015Cohen 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.
- Derived from this study: PubMed 36184966Zarr 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.
- Individual participant dataSharing planned: Yes. After the study is completed we will de-identify data and post on the ICSPR website
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah A Cohen, MD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Park Rx in people with Physical Activity and Mental Health Wellness 1, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity (time frame: Baseline, 3 months, 6 months 12 months and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114734, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.