Park Rx and Physical Activity Among Low-income Children

Physical Activity Clinical Trial

— ParkRx  

Official title:

Park Rx, Physical Activity and Other Health Benefits Among Low-income Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04114734
• Other study ID #: R01HL147574
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 27, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness 1
• Physical Activity

Intervention

Behavioral:
• Park Rx
Participants will be advised to visit a specific park at a specific frequency and duration

Locations

Country	Name	City	State
United States	Kaiser Permanente	Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Unity Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in BMI percentile	We will review the electronic health record for BMI	2 years
Other	Change in Lipids	EHR review	2 years
Primary	Change in Physical Activity	Accelerometer measured	Baseline, 3 months, 6 months 12 months and 2 years
Secondary	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