Clinical trial NCT04114734: Park Rx and Physical Activity Among Low-income Children
Official title: Park Rx, Physical Activity and Other Health Benefits Among Low-income Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physical Activity
Mental Health Wellness 1
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Unity Health
First posted: 2019-10-03
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to get Park Rx or to receive care as usual.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline, 3 months, 6 months 12 months and 2 years
Secondary outcomes:
measure: Change in Cognition
timeFrame: Baseline, 3 months, 6 months 12 months and 2 years
Other outcomes:
measure: Change in BMI percentile
timeFrame: 2 years
measure: Change in Lipids
timeFrame: 2 years
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: Kaiser Permanente
name: Deborah A Cohen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.