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Nature and Health: How Does Lifestyle and Environment Affect Health and Wellness

Primary Purpose

Chronic Disease, Risk Reduction, Mental Health Wellness 1

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Park prescription
Regular health advice
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease focused on measuring Nature, Park prescription, Mental health, Physical health, Chronic disease, Lifestyle

Eligibility Criteria

13 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must be a patient of the AHN Forbes Family Medicine clinic (Monroeville location only). 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Intervention

    Control

    Arm Description

    The treatment group will receive information regarding wellness factors by the doctor (health advice) and they will be asked to follow those recommendations for the duration of the study. In addition they will also receive a park prescription specifying a 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 (Monroeville, PA).

    The control group will receive regular health advice and information regarding wellness factors by the doctor and they will be asked to follow those recommendations for the duration of the study.

    Outcomes

    Primary Outcome Measures

    Nature Exposure Scale II (NES-II)
    Assess each participant's exposure to nature in everyday life. The Nature Exposure Scale II uses a 5-point likert scale for each item. Higher score means greater exposure to nature. The total score is an average of all the items included.

    Secondary Outcome Measures

    CDC Health related quality of life - 14 (CDC-HRQOL-14)
    The Health related quality of life scale rates an individual's perceived physical and mental health over time. The main outcome score is the unhealthy days index, computed by adding a respondent's physically and mentally unhealthy days. Score goes from 0-30 where higher is worse.
    Brief-Pittsburgh Sleep Quality Index (B-PSQI)
    Brief-Pittsburgh Sleep Quality Index assesses an individuals perceived sleep quality. The questionnaires contains 6 items and the total score ranges from 0-15 where higher scores indicate worse sleep.
    Perceived Stress Scale (PSS-10)
    The Perceived Stress Scale is a measure of an individuals perceived stress levels. 10-items with scoring from 0-4 were higher is higher levels of perceived stress (worse). Total score is obtained by summing across all items.
    International Physical Activity Questionnaire Short form (IPAQ-S)
    The International Physical Activity Questionnaire - Short Form rates an individuals physical activity levels and types of exercise. The questionnaire consists of 7 items that measures days physically active as well as duration. Scores will calculated as categorical low/medium/high where higher is more active (1-3). And continuous by calculating metabolic equivalent of task (MET) minutes for a week MET-minutes/week where higher is better. 0-10000
    Patient Health Questionnaire (PHQ-8/PHQ-A)
    The Patient Health Questionnaire is a scale for measuring depression in adults. The scale has 8 items and the scores ranges from 0-3. The total score ranges from 0-24 where higher is more depression (worse). The Patient Health Questionnaire - Adolescence measures depression in teens (PHQ-A). The scale consists of 9 items and scores from 0-3 and a total score of 27. Where higher scores is worse (more depression).
    General Anxiety Disorder (GAD-7)
    The General Anxiety Disorder questionnaire is a scale for measuring levels of anxiety in individuals. The scale has 7 items and each items is scored 0-3 where the total score ranges from 0-21 where higher is worse (more anxiety).
    Step count
    Daily step count measured through the Garmin Vivosmart 5. Steps measured is day can range from 0 to unlimited where higher steps is considered better (more physical activity). Total steps will be averaged by days to calculate an average steps per days.
    Green view index
    Individuals nature exposure level measured through their GPS trajectories and Google Street View (GSV) images. Higher scores is better (more green space exposure).
    Urban Mind mental health assessment
    Scores of the mental health assessment taken every 72-hours. The Urban Mind mental health assessment consists of one question which rates mental health from 1-5 where higher is better (poor/fair/good/very good/excellent). The total score will be the average score per day.
    Urban Mind physical health assessment
    Scores of the physical health assessment taken every 72-hours. The Urban Mind physical health assessment consists of one question which rates physical health from 1-5 where higher is better (poor/fair/good/very good/excellent). The total score will be the average score per day.
    Urban Mind physical activity assessment
    Scores of the physical activity assessment taken every 72-hours. The Urban Mind physical activity assessment consists of one question which rates physical activity in minutes by increments where higher is better (None/<10/10-30/30-60/60-120/>120. The categories are converted into likert scale scores 1-6 and the total score is the average score.
    Urban Mind nature exposure assessment
    Scores of the nature exposure assessment taken every 72-hours. The Urban Mind nature exposure assessment consists of one question which rates nature exposure in minutes by increments where higher is better (None/<10/10-30/30-60/60-120/>120. The categories are converted into likest scale scores 1-6 and the total score is the average score.

    Full Information

    First Posted
    August 14, 2023
    Last Updated
    October 19, 2023
    Sponsor
    Stanford University
    Collaborators
    Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), Richard King Mellon Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06001697
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University
    Collaborators
    Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), Richard King Mellon Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 (Monroeville, PA). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Disease, Risk Reduction, Mental Health Wellness 1, Physical Inactivity, Sleep, Depression, Anxiety
    Keywords
    Nature, Park prescription, Mental health, Physical health, Chronic disease, Lifestyle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    The treatment group will receive information regarding wellness factors by the doctor (health advice) and they will be asked to follow those recommendations for the duration of the study. In addition they will also receive a park prescription specifying a 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 (Monroeville, PA).
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    The control group will receive regular health advice and information regarding wellness factors by the doctor and they will be asked to follow those recommendations for the duration of the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Park prescription
    Intervention Description
    The park prescription given by the patients care-provider includes information about the health benefits of spending time in nature and detailed information about the parks in the neighbouring area (Monroeville, PA). As well as access to a web-based platform called ParkRx which includes information and details about events in the parks in or close by Monroeville, PA. Together with information about the frequency and duration of visits to the parks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Regular health advice
    Intervention Description
    Regular health advice relating to lifestyle factors that can decrease the risk of chronic disease and/or reducing the burden of an existing chronic disease. Areas included are diet, physical activity, sleep, stress and medications.
    Primary Outcome Measure Information:
    Title
    Nature Exposure Scale II (NES-II)
    Description
    Assess each participant's exposure to nature in everyday life. The Nature Exposure Scale II uses a 5-point likert scale for each item. Higher score means greater exposure to nature. The total score is an average of all the items included.
    Time Frame
    Baseline and 6-months
    Secondary Outcome Measure Information:
    Title
    CDC Health related quality of life - 14 (CDC-HRQOL-14)
    Description
    The Health related quality of life scale rates an individual's perceived physical and mental health over time. The main outcome score is the unhealthy days index, computed by adding a respondent's physically and mentally unhealthy days. Score goes from 0-30 where higher is worse.
    Time Frame
    Baseline and 6-months
    Title
    Brief-Pittsburgh Sleep Quality Index (B-PSQI)
    Description
    Brief-Pittsburgh Sleep Quality Index assesses an individuals perceived sleep quality. The questionnaires contains 6 items and the total score ranges from 0-15 where higher scores indicate worse sleep.
    Time Frame
    Baseline and 6-months
    Title
    Perceived Stress Scale (PSS-10)
    Description
    The Perceived Stress Scale is a measure of an individuals perceived stress levels. 10-items with scoring from 0-4 were higher is higher levels of perceived stress (worse). Total score is obtained by summing across all items.
    Time Frame
    Baseline and 6-months
    Title
    International Physical Activity Questionnaire Short form (IPAQ-S)
    Description
    The International Physical Activity Questionnaire - Short Form rates an individuals physical activity levels and types of exercise. The questionnaire consists of 7 items that measures days physically active as well as duration. Scores will calculated as categorical low/medium/high where higher is more active (1-3). And continuous by calculating metabolic equivalent of task (MET) minutes for a week MET-minutes/week where higher is better. 0-10000
    Time Frame
    Baseline and 6-months
    Title
    Patient Health Questionnaire (PHQ-8/PHQ-A)
    Description
    The Patient Health Questionnaire is a scale for measuring depression in adults. The scale has 8 items and the scores ranges from 0-3. The total score ranges from 0-24 where higher is more depression (worse). The Patient Health Questionnaire - Adolescence measures depression in teens (PHQ-A). The scale consists of 9 items and scores from 0-3 and a total score of 27. Where higher scores is worse (more depression).
    Time Frame
    Baseline and 6-months
    Title
    General Anxiety Disorder (GAD-7)
    Description
    The General Anxiety Disorder questionnaire is a scale for measuring levels of anxiety in individuals. The scale has 7 items and each items is scored 0-3 where the total score ranges from 0-21 where higher is worse (more anxiety).
    Time Frame
    Baseline and 6-months
    Title
    Step count
    Description
    Daily step count measured through the Garmin Vivosmart 5. Steps measured is day can range from 0 to unlimited where higher steps is considered better (more physical activity). Total steps will be averaged by days to calculate an average steps per days.
    Time Frame
    From study start until study end (6 months)
    Title
    Green view index
    Description
    Individuals nature exposure level measured through their GPS trajectories and Google Street View (GSV) images. Higher scores is better (more green space exposure).
    Time Frame
    From study start until study end (6 months)
    Title
    Urban Mind mental health assessment
    Description
    Scores of the mental health assessment taken every 72-hours. The Urban Mind mental health assessment consists of one question which rates mental health from 1-5 where higher is better (poor/fair/good/very good/excellent). The total score will be the average score per day.
    Time Frame
    From study start until study end (6 months)
    Title
    Urban Mind physical health assessment
    Description
    Scores of the physical health assessment taken every 72-hours. The Urban Mind physical health assessment consists of one question which rates physical health from 1-5 where higher is better (poor/fair/good/very good/excellent). The total score will be the average score per day.
    Time Frame
    From study start until study end (6 months)
    Title
    Urban Mind physical activity assessment
    Description
    Scores of the physical activity assessment taken every 72-hours. The Urban Mind physical activity assessment consists of one question which rates physical activity in minutes by increments where higher is better (None/<10/10-30/30-60/60-120/>120. The categories are converted into likert scale scores 1-6 and the total score is the average score.
    Time Frame
    From study start until study end (6 months)
    Title
    Urban Mind nature exposure assessment
    Description
    Scores of the nature exposure assessment taken every 72-hours. The Urban Mind nature exposure assessment consists of one question which rates nature exposure in minutes by increments where higher is better (None/<10/10-30/30-60/60-120/>120. The categories are converted into likest scale scores 1-6 and the total score is the average score.
    Time Frame
    From study start until study end (6 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must be a patient of the AHN Forbes Family Medicine clinic (Monroeville location only). 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sophie McCormick, BSc
    Phone
    (412) 266-9713
    Email
    Sophie.Mccormick@ahn.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria Gioia, MD
    Email
    maria.gioia@ahn.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gretchen Daily, PhD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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