xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06001697</url>
    </required_header>
    <id_info>
      <org_study_id>NH001</org_study_id>
      <nct_id>NCT06001697</nct_id>
    </id_info>
    <brief_title>Nature and Health: How Does Lifestyle and Environment Affect Health and Wellness</brief_title>
    <official_title>Nature and Health: How Does Lifestyle and Environment Affect Health and Wellness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Allegheny Health Network</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Richard King Mellon Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Stanford University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to examine if and how implementing nature prescriptions can&#xD;
        increase time in nature and improve health to yield an actionable understanding of the&#xD;
        nature-health connection. It aims to explore how public green spaces can be better used to&#xD;
        improve individual and community health. Finally, this study aims to advance science by&#xD;
        conducting a randomized controlled trial to improve understanding of the linkages between&#xD;
        time in nature and human health.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators will conduct a randomized controlled trial in which physicians prescribe&#xD;
        time in nature as an intervention to the study group. In total a goal of 240 patients will be&#xD;
        recruited, including both children (13+) and adults. 120 of them will be assigned to the&#xD;
        study group and 120 to the assigned to the control group. All study participants will be&#xD;
        provided with a Global Positioning System (GPS)-enabled wearable device (Garmin Vivosmart 5)&#xD;
        that is able to measure their activity levels, location, and additional health-related&#xD;
        metrics, such as heart rate. All participants will be asked to provide information about&#xD;
        their health and well-being through survey instruments and electronic health records. Both&#xD;
        groups (intervention and control) will receive regular health advice targeting lifestyle&#xD;
        factors associated with risk of chronic diseases. The treatment group will additionally&#xD;
        receive a park prescription with information about the benefits of spending time in nature.&#xD;
        They will also received a specified target amount of time to spend in nature, along with&#xD;
        frequency of visits and recommended locations (e.g., specific parks), and information about&#xD;
        parks and programming in the study area (Monroeville, PA). Participants will also be asked to&#xD;
        answer brief questions regarding their mental and physical health, as well as their physical&#xD;
        excercise patterns every 72-hours through a research-grade smartphone app called Urban Mind&#xD;
        over the course of this study. At baseline and end of study at 6-months the participants will&#xD;
        also answer questionnaires that will assess their mental and physical health, as well as&#xD;
        lifestyle factors such as physical activity, sleep, stress and exposure to nature. These&#xD;
        questionnaires will be administered through the REDCap survey system.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Nature Exposure Scale II (NES-II)</measure>
      <time_frame>Baseline and 6-months</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CDC Health related quality of life - 14 (CDC-HRQOL-14)</measure>
      <time_frame>Baseline and 6-months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief-Pittsburgh Sleep Quality Index (B-PSQI)</measure>
      <time_frame>Baseline and 6-months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress Scale (PSS-10)</measure>
      <time_frame>Baseline and 6-months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>International Physical Activity Questionnaire Short form (IPAQ-S)</measure>
      <time_frame>Baseline and 6-months</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-8/PHQ-A)</measure>
      <time_frame>Baseline and 6-months</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Anxiety Disorder (GAD-7)</measure>
      <time_frame>Baseline and 6-months</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Step count</measure>
      <time_frame>From study start until study end (6 months)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Green view index</measure>
      <time_frame>From study start until study end (6 months)</time_frame>
      <description>Individuals nature exposure level measured through their GPS trajectories and Google Street View (GSV) images. Higher scores is better (more green space exposure).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urban Mind mental health assessment</measure>
      <time_frame>From study start until study end (6 months)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urban Mind physical health assessment</measure>
      <time_frame>From study start until study end (6 months)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urban Mind physical activity assessment</measure>
      <time_frame>From study start until study end (6 months)</time_frame>
      <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/&lt;10/10-30/30-60/60-120/&gt;120. The categories are converted into likert scale scores 1-6 and the total score is the average score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urban Mind nature exposure assessment</measure>
      <time_frame>From study start until study end (6 months)</time_frame>
      <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/&lt;10/10-30/30-60/60-120/&gt;120. The categories are converted into likest scale scores 1-6 and the total score is the average score.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Chronic Disease</condition>
    <condition>Risk Reduction</condition>
    <condition>Mental Health Wellness 1</condition>
    <condition>Physical Inactivity</condition>
    <condition>Sleep</condition>
    <condition>Depression</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Park prescription</intervention_name>
      <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.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Regular health advice</intervention_name>
      <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.</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants must be a patient of the AHN Forbes Family Medicine clinic (Monroeville&#xD;
               location only).&#xD;
  &#xD;
            -  Participants must have one or more chronic conditions, or significant lifestyle risks&#xD;
               as identified by their healthcare provider.&#xD;
  &#xD;
            -  Participants must be between 13-65 years old.&#xD;
  &#xD;
            -  Participants must be willing and able to provide informed consent to participate&#xD;
  &#xD;
            -  Participants under 18 must be willing and able to assent for themselves and obtain&#xD;
               parental consent.&#xD;
  &#xD;
            -  Participants must be willing to comply with all study procedures for the duration of&#xD;
               the study.&#xD;
  &#xD;
            -  Participants must reside in the greater Pittsburgh area for the duration of 6-month&#xD;
               study.&#xD;
  &#xD;
            -  Participants must have a smartphone that is capable of running the Urban Mind App and&#xD;
               connecting to the Garmin wearable device (iPhone 6 and newer as well as most Android&#xD;
               phones).&#xD;
  &#xD;
            -  Minors who participate must have their own smartphone.&#xD;
  &#xD;
            -  Participants must have their own email address to register with the Urban Mind App and&#xD;
               the Garmin App.&#xD;
  &#xD;
            -  Only one participant from a household may enroll in the study.&#xD;
  &#xD;
            -  Participants must be able to comprehend written English (questionnaires will be&#xD;
               provided to participants in English).&#xD;
  &#xD;
            -  Participants may not be an employee of Forbes Family Medicine clinic&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None, must meet all inclusion criteria.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gretchen Daily, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sophie McCormick, BSc</last_name>
      <phone>(412) 266-9713</phone>
      <email>Sophie.Mccormick@ahn.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maria Gioia, MD</last_name>
      <email>maria.gioia@ahn.org</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Gretchen Daily</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Nature</keyword>
    <keyword>Park prescription</keyword>
    <keyword>Mental health</keyword>
    <keyword>Physical health</keyword>
    <keyword>Chronic disease</keyword>
    <keyword>Lifestyle</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06001697
  org study id: NH001
  nct id: NCT06001697
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  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
  masking: Single (Participant)
  measure: Nature Exposure Scale II (NES-II)
  time frame: Baseline and 6-months
  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.
  measure: CDC Health related quality of life - 14 (CDC-HRQOL-14)
  time frame: Baseline and 6-months
  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.
  measure: Brief-Pittsburgh Sleep Quality Index (B-PSQI)
  time frame: Baseline and 6-months
  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.
  measure: Perceived Stress Scale (PSS-10)
  time frame: Baseline and 6-months
  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.
  measure: International Physical Activity Questionnaire Short form (IPAQ-S)
  time frame: Baseline and 6-months
  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
  measure: Patient Health Questionnaire (PHQ-8/PHQ-A)
  time frame: Baseline and 6-months
  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).
  measure: General Anxiety Disorder (GAD-7)
  time frame: Baseline and 6-months
  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).
  measure: Step count
  time frame: From study start until study end (6 months)
  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.
  measure: Green view index
  time frame: From study start until study end (6 months)
  description: Individuals nature exposure level measured through their GPS trajectories and Google Street View (GSV) images. Higher scores is better (more green space exposure).
  measure: Urban Mind mental health assessment
  time frame: From study start until study end (6 months)
  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.
  measure: Urban Mind physical health assessment
  time frame: From study start until study end (6 months)
  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.
  measure: Urban Mind physical activity assessment
  time frame: From study start until study end (6 months)
  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.
  measure: Urban Mind nature exposure assessment
  time frame: From study start until study end (6 months)
  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.
  arm group label: Intervention
  arm group type: Experimental
  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 group label: Control
  arm group type: Other
  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: Park prescription
  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.
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: Regular health advice
  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.
  arm group label: Control
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Gretchen Daily, PhD
  role: Principal Investigator
  affiliation: Stanford University
  last name: Sophie McCormick, BSc
  phone: (412) 266-9713
  email: Sophie.Mccormick@ahn.org
  last name: Maria Gioia, MD
  email: maria.gioia@ahn.org
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Gretchen Daily
  investigator title: Professor
  mesh term: Chronic Disease
  sharing ipd: No