<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/NCT03007901</url>
  </required_header>
  <id_info>
    <org_study_id>2016-1336</org_study_id>
    <nct_id>NCT03007901</nct_id>
  </id_info>
  <brief_title>Mindful Climate Action: Improving Health While Reducing Carbon Footprint</brief_title>
  <official_title>Mindful Climate Action: Improving Health While Reducing Carbon Footprint: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To work with community partners to pilot test a mindfulness-based behavioral program aimed&#xD;
      at: (a) enhancement of health and well-being, and (b) reduction in carbon footprint; (2) to&#xD;
      develop, implement, and refine methods for assessing carbon footprint at the individual&#xD;
      level; and (3) to work with pilot participants and community partners to carry out a&#xD;
      proof-of-concept research study to assess impact on health, well-being, and carbon footprint.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Pilot Study will be conducted to allow us to evaluate and test the various study&#xD;
      processes, including: consent/enrollment, run-in-trial monitoring, measurement tools, outcome&#xD;
      assessment, educational materials, and especially the mindfulness-based climate action&#xD;
      trainings. The pilot study does not include a control group, and data will not be used for&#xD;
      efficacy outcome analysis. The investigators anticipate doing two pilot cohorts of roughly 16&#xD;
      persons/group. The pilot cohorts will not be simultaneous.&#xD;
&#xD;
      Participants will meet for 2½ hour sessions, once per week for eight weeks. An additional&#xD;
      6-hour retreat will be scheduled over a weekend towards the end of the program. Participants&#xD;
      will receive about 26 hours of contact time. Their daily home practice will be guided by&#xD;
      audio recordings (25 to 45 minutes) that lead them through their formal meditation practice&#xD;
      of the body scan, sitting meditations, and gentle yoga. Participants will be asked to&#xD;
      practice for 5 or 6 days per week at home, using these audio recordings or on their own. They&#xD;
      will also be asked to select a daily practice time that works best for them, perhaps early&#xD;
      morning, after work, or later in the evening. Participants will record what they practice and&#xD;
      for how long either on paper log sheets or using a web-based data form.&#xD;
&#xD;
      Climate change, energy, and carbon footprint knowledge will be assessed by a college&#xD;
      intro-level test (pre- and post-training). Electrical and gas use will be assessed directly&#xD;
      by inspecting Madison Gas and Electric (MG&amp;E) utility records. Miles driven in automobile&#xD;
      will be assessed by self-report, verified with odometer readings of primary vehicle done by&#xD;
      study staff. Active transportation and motor vehicle travel will be measured using a free,&#xD;
      smart phone app called MOVES. In order to extract the activity data from the user's phone,&#xD;
      each participant will download another free app called TRAQS CSV Exporter&#xD;
      (https://labs.traqs.me/moves/) which will export data once monthly over the course of the&#xD;
      year. Individual movement/transportation activity data obtained from this app will provide&#xD;
      the study team with data allowing an in-depth and fine-grained understanding of&#xD;
      transportation behaviors across the study time period.&#xD;
&#xD;
      Dietary composition will be assessed by validated dietary recall, with proportion of dietary&#xD;
      calories from animal versus plant sources as the primary assessment. Composite carbon&#xD;
      footprints will be calculated. In addition to carbon footprint, the investigators will be&#xD;
      assessing health co-benefits, including several domains of mental and physical health&#xD;
      (validated self-report measures) and active transport assessed using Actigraph&#xD;
      accelerometers.&#xD;
&#xD;
      Participants will be asked to provide feedback through interviews regarding the curriculum.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">September 15, 2017</completion_date>
  <primary_completion_date type="Actual">September 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimated carbon footprint</measure>
    <time_frame>6 months</time_frame>
    <description>Carbon footprint (CF) will be estimated. Individual-level carbon footprints (ICF) are assessed as ICF = ΣCiEi where each term is the product of the degree of consumption (C) and the CO2 equivalent radiative forcing emission (E) of that input (i). Greenhouse gas emission (E) weightings applied to individual consumption levels (C) will be expressed in metric tons CO2-equivalent/year (CO2e).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Pilot Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This Pilot Study will be conducted to allow us to evaluate and test the various study processes, including: consent/enrollment, run-in-trial monitoring, measurement tools, outcome assessment, educational materials, and especially the mindfulness-based climate action trainings. The pilot study does not include a control group, and data will not be used for efficacy outcome analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindful Climate Action</intervention_name>
    <description>Educational and Behavioral Training Curriculum: An article describing our proposed program was recently published in Sustainability (1) and is summarized here. Experienced instructors from the UW Integrative Medicine Mindfulness Program will teach the 8-week program. Classes will meet weekly for 2½ hours, with a 6 hour weekend retreat. Twenty to 45 minutes of daily home practice will be guided by audio recordings leading participants through body scan, sitting meditations, breath awareness, and mindful movement. Each of the 2½ hour weekly classes includes topics (~30 min) relating to climate change, energy use, and carbon footprint.</description>
    <arm_group_label>Pilot Cohort 1</arm_group_label>
    <other_name>MBSR with Climate Education</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 30 to 65 years at enrollment will be assessed by self-report and date of birth.&#xD;
             This relatively broad age range will facilitate enrollment and will enhance&#xD;
             generalizability of results. This range will also tend to include people with moderate&#xD;
             to large carbon footprints, possibly allowing room for measurable improvement with&#xD;
             mindfulness training.&#xD;
&#xD;
          -  Fluency in English (oral, reading, and writing) is necessary to complete all study&#xD;
             parameters including: providing consent, completion of questionnaires and online&#xD;
             surveys, and intervention objectives.&#xD;
&#xD;
          -  Willingness and ability to carry out all study-specific tasks, including commitment to&#xD;
             provide data, wear an ActiGraph for one week twice over the course of the study, and&#xD;
             be monitored throughout the research study period.&#xD;
&#xD;
          -  Participants must be owners (or co-owners) of single family dwelling, and must have&#xD;
             been in the same location for the prior 12 months, with no expectation of moving&#xD;
             during the study. Utility service to the single family dwelling must be provided by&#xD;
             MG&amp;E (gas and electric) and Madison Water Utility. This is necessary to accurately&#xD;
             assess and compare household energy and water use across participants and randomized&#xD;
             groups.&#xD;
&#xD;
          -  Participants must own (or co-own or lease) an automobile and drive it at least 5000&#xD;
             miles per year (assessed by self-report). The choice of 5,000 miles as cutoff is&#xD;
             arbitrary, but will exclude those who do not drive much, and would therefore have less&#xD;
             capacity for measureable improvement. People who share the use of a car with no more&#xD;
             than one other person but who drive the majority of miles will be included, as will&#xD;
             people who own and drive two primary vehicles. People who own and regularly drive more&#xD;
             than two vehicles will be excluded due to the added participant and staff burden&#xD;
             involved with obtaining odometer readings.&#xD;
&#xD;
          -  Ownership, use, and familiarity with a smart phone (either iPhone or Android type)&#xD;
             will be required due to planned use of the MOVES app to obtain major outcome data.&#xD;
&#xD;
          -  Only one member per household will be allowed to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded if they currently or recently participate in meditative&#xD;
             practice or mindfulness or other meditation training in the past 3 years. Assessed by&#xD;
             answering &quot;Yes&quot; to any of the following questions: Do you meditate on a regular basis?&#xD;
             In the last year, have you meditated at least weekly for 2 or more months in a row?&#xD;
             Have you received meditation training in the last 5 years? Have you taken part in a&#xD;
             mindfulness class or mindfulness sessions during the past 5 years?&#xD;
&#xD;
          -  People with self-described vegan or vegetarian diets (self-assessed average meat&#xD;
             ingestion frequency less than once/week) will be excluded, as one goal of the&#xD;
             trainings is to influence dietary habits away from meats (especially beef) and towards&#xD;
             vegetables and other plant-based foods. Only those who answer &quot;Yes&quot; to &quot;Do you tend to&#xD;
             eat at least one meal with some meat in it on most days of the week?&quot; will be eligible&#xD;
             to participate.&#xD;
&#xD;
          -  People with serious physical, medical, or mental condition precluding adherence to&#xD;
             study protocol will be excluded. Questionable cases will be reviewed by the study&#xD;
             physicians.&#xD;
&#xD;
          -  Those that are unable/unwilling to successfully complete baseline assessment,&#xD;
             including in-person meetings, data-collection, and other tasks will be excluded from&#xD;
             the study. Inability to complete a sample of the study requirements will indicate an&#xD;
             inability to complete full study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce Barrett, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <link>
    <url>http://www.mdpi.com/2071-1050/8/10/1040</url>
    <description>Sustainability. 2016 October 17; 8(10):1040</description>
  </link>
  <reference>
    <citation>Barrett B, Grabow M, Middlecamp C, Mooney M, Checovich MM, Converse AK, Gillespie B, Yates J. Mindful Climate Action: Health and Environmental Co-Benefits from Mindfulness-Based Behavioral Training. Sustainability. 2016 Oct;8(10):1040. doi: 10.3390/su8101040. Epub 2016 Oct 17.</citation>
    <PMID>28008371</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03007901
org study id: 2016-1336
nct id: NCT03007901
lead sponsor: 
has dmc: No
To work with community partners to pilot test a mindfulness-based behavioral program aimed
      at: (a) enhancement of health and well-being, and (b) reduction in carbon footprint; (2) to
      develop, implement, and refine methods for assessing carbon footprint at the individual
      level; and (3) to work with pilot participants and community partners to carry out a
      proof-of-concept research study to assess impact on health, well-being, and carbon footprint.
This Pilot Study will be conducted to allow us to evaluate and test the various study
      processes, including: consent/enrollment, run-in-trial monitoring, measurement tools, outcome
      assessment, educational materials, and especially the mindfulness-based climate action
      trainings. The pilot study does not include a control group, and data will not be used for
      efficacy outcome analysis. The investigators anticipate doing two pilot cohorts of roughly 16
      persons/group. The pilot cohorts will not be simultaneous.

      Participants will meet for 2½ hour sessions, once per week for eight weeks. An additional
      6-hour retreat will be scheduled over a weekend towards the end of the program. Participants
      will receive about 26 hours of contact time. Their daily home practice will be guided by
      audio recordings (25 to 45 minutes) that lead them through their formal meditation practice
      of the body scan, sitting meditations, and gentle yoga. Participants will be asked to
      practice for 5 or 6 days per week at home, using these audio recordings or on their own. They
      will also be asked to select a daily practice time that works best for them, perhaps early
      morning, after work, or later in the evening. Participants will record what they practice and
      for how long either on paper log sheets or using a web-based data form.

      Climate change, energy, and carbon footprint knowledge will be assessed by a college
      intro-level test (pre- and post-training). Electrical and gas use will be assessed directly
      by inspecting Madison Gas and Electric (MG&E) utility records. Miles driven in automobile
      will be assessed by self-report, verified with odometer readings of primary vehicle done by
      study staff. Active transportation and motor vehicle travel will be measured using a free,
      smart phone app called MOVES. In order to extract the activity data from the user's phone,
      each participant will download another free app called TRAQS CSV Exporter
      (https://labs.traqs.me/moves/) which will export data once monthly over the course of the
      year. Individual movement/transportation activity data obtained from this app will provide
      the study team with data allowing an in-depth and fine-grained understanding of
      transportation behaviors across the study time period.

      Dietary composition will be assessed by validated dietary recall, with proportion of dietary
      calories from animal versus plant sources as the primary assessment. Composite carbon
      footprints will be calculated. In addition to carbon footprint, the investigators will be
      assessing health co-benefits, including several domains of mental and physical health
      (validated self-report measures) and active transport assessed using Actigraph
      accelerometers.

      Participants will be asked to provide feedback through interviews regarding the curriculum.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Estimated carbon footprint
time frame: 6 months
description: Carbon footprint (CF) will be estimated. Individual-level carbon footprints (ICF) are assessed as ICF = ΣCiEi where each term is the product of the degree of consumption (C) and the CO2 equivalent radiative forcing emission (E) of that input (i). Greenhouse gas emission (E) weightings applied to individual consumption levels (C) will be expressed in metric tons CO2-equivalent/year (CO2e).
arm group label: Pilot Cohort 1
arm group type: Experimental
description: This Pilot Study will be conducted to allow us to evaluate and test the various study processes, including: consent/enrollment, run-in-trial monitoring, measurement tools, outcome assessment, educational materials, and especially the mindfulness-based climate action trainings. The pilot study does not include a control group, and data will not be used for efficacy outcome analysis.
intervention type: Behavioral
intervention name: Mindful Climate Action
description: Educational and Behavioral Training Curriculum: An article describing our proposed program was recently published in Sustainability (1) and is summarized here. Experienced instructors from the UW Integrative Medicine Mindfulness Program will teach the 8-week program. Classes will meet weekly for 2½ hours, with a 6 hour weekend retreat. Twenty to 45 minutes of daily home practice will be guided by audio recordings leading participants through body scan, sitting meditations, breath awareness, and mindful movement. Each of the 2½ hour weekly classes includes topics (~30 min) relating to climate change, energy use, and carbon footprint.
arm group label: Pilot Cohort 1
other name: MBSR with Climate Education
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bruce Barrett, MD PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
url: http://www.mdpi.com/2071-1050/8/10/1040
description: Sustainability. 2016 October 17; 8(10):1040
citation: Barrett B, Grabow M, Middlecamp C, Mooney M, Checovich MM, Converse AK, Gillespie B, Yates J. Mindful Climate Action: Health and Environmental Co-Benefits from Mindfulness-Based Behavioral Training. Sustainability. 2016 Oct;8(10):1040. doi: 10.3390/su8101040. Epub 2016 Oct 17.
PMID: 28008371
responsible party type: Sponsor
sharing ipd: No