Clinical trial NCT06001697: Nature and Health: How Does Lifestyle and Environment Affect Health and Wellness
Official title: Nature and Health: How Does Lifestyle and Environment Affect Health and Wellness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Risk Reduction
Mental Health Wellness 1
Physical Inactivity
Sleep
Depression
Anxiety
Keywords: Nature
Park prescription
Mental health
Physical health
Chronic disease
Lifestyle
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: Richard King Mellon Foundation
First posted: 2023-08-21
Enrollment: 134
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In total a goal of 240 patients will be recruited and randomised in a 1:1 ration to either the intervention or control group. This means 120 of them will be assigned to the study group and 120 to the assigned to the control group. The intervention group will receive health advice and a park prescription by their health care provider while the control group will receive regular health advice regarding lifestyle.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine if and how implementing nature prescriptions can increase time in nature and improve health to yield an actionable understanding of the nature-health connection. It aims to explore how public green spaces can be better used to improve individual and community health. Finally, this study aims to advance science by conducting a randomized controlled trial to improve understanding of the linkages between time in nature and human health.

Detailed description: The investigators will conduct a randomized controlled trial in which physicians prescribe time in nature as an intervention to the study group. In total a goal of 240 patients will be recruited, including both children (13+) and adults. 120 of them will be assigned to the study group and 120 to the assigned to the control group. All study participants will be provided with a Global Positioning System (GPS)-enabled wearable device (Garmin Vivosmart 5) that is able to measure their activity levels, location, and additional health-related metrics, such as heart rate. All participants will be asked to provide information about their health and well-being through survey instruments and electronic health records. Both groups (intervention and control) will receive regular health advice targeting lifestyle factors associated with risk of chronic diseases. The treatment group will additionally receive a park prescription with information about the benefits of spending time in nature. They will also received a specified target amount of time to spend in nature, along with frequency of visits and recommended locations (e.g., specific parks), and information about parks and programming in the study area. Participants will also be asked to answer brief questions regarding their mental and physical health, as well as their physical excercise patterns every 72-hours through a research-grade smartphone app called Urban Mind over the course of this study. At baseline and end of study at 6-months the participants will also answer questionnaires that will assess their mental and physical health, as well as lifestyle factors such as physical activity, sleep, stress and exposure to nature. These questionnaires will be administered through the REDCap survey system.

Eligibility criteria: Inclusion Criteria:

* Participants must be a patient of the AHN Forbes Family Medicine clinic.
* Participants must have one or more chronic conditions, or significant lifestyle risks as identified by their healthcare provider.
* Participants must be between 13-65 years old.
* Participants must be willing and able to provide informed consent to participate
* Participants under 18 must be willing and able to assent for themselves and obtain parental consent.
* Participants must be willing to comply with all study procedures for the duration of the study.
* Participants must reside in the greater Pittsburgh area for the duration of 6-month study.
* Participants must have a smartphone that is capable of running the Urban Mind App and connecting to the Garmin wearable device (iPhone 6 and newer as well as most Android phones).
* Minors who participate must have their own smartphone.
* Participants must have their own email address to register with the Urban Mind App and the Garmin App.
* Only one participant from a household may enroll in the study.
* Participants must be able to comprehend written English (questionnaires will be provided to participants in English).
* Participants may not be an employee of Forbes Family Medicine clinic

Exclusion Criteria:

* None, must meet all inclusion criteria.

Primary outcomes:
measure: Nature Exposure Scale II (NES-II)
timeFrame: Baseline and 6-months
Secondary outcomes:
measure: CDC Health related quality of life - 14 (CDC-HRQOL-14)
timeFrame: Baseline and 6-months
measure: Brief-Pittsburgh Sleep Quality Index (B-PSQI)
timeFrame: Baseline and 6-months
measure: Perceived Stress Scale (PSS-10)
timeFrame: Baseline and 6-months
measure: International Physical Activity Questionnaire Short form (IPAQ-S)
timeFrame: Baseline and 6-months
measure: Patient Health Questionnaire (PHQ-8/PHQ-A)
timeFrame: Baseline and 6-months
measure: General Anxiety Disorder (GAD-7)
timeFrame: Baseline and 6-months
measure: Step count
timeFrame: From study start until study end (6 months)
measure: Green view index
timeFrame: From study start until study end (6 months)
measure: Urban Mind mental health assessment
timeFrame: From study start until study end (6 months)
measure: Urban Mind physical health assessment
timeFrame: From study start until study end (6 months)
measure: Urban Mind physical activity assessment
timeFrame: From study start until study end (6 months)
measure: Urban Mind nature exposure assessment
timeFrame: From study start until study end (6 months)
Other outcomes:
Locations:
city: Monroeville
country: United States
facility: Forbes Family Medicine/AHN Research Institute
state: Pennsylvania
Study officials:
affiliation: Stanford University
name: Gretchen Daily, PhD
role: PRINCIPAL_INVESTIGATOR
References: