Health BehaviorNCT03007901
Mindful Climate Action: Improving Health While Reducing Carbon Footprint
A study testing Mindful Climate Action in people with Health Behavior, run by University of Wisconsin, Madison.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Mindful Climate Action
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 15 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30 to 65 years at enrollment will be assessed by self-report and date of birth. This relatively broad age range will facilitate enrollment and will enhance generalizability of results. This range will also tend to include people with moderate to large carbon footprints, possibly allowing room for measurable improvement with mindfulness training.
- Fluency in English (oral, reading, and writing) is necessary to complete all study parameters including: providing consent, completion of questionnaires and online surveys, and intervention objectives.
- Willingness and ability to carry out all study-specific tasks, including commitment to provide data, wear an ActiGraph for one week twice over the course of the study, and be monitored throughout the research study period.
- Participants must be owners (or co-owners) of single family dwelling, and must have been in the same location for the prior 12 months, with no expectation of moving during the study. Utility service to the single family dwelling must be provided by MG\&E (gas and electric) and Madison Water Utility. This is necessary to accurately assess and compare household energy and water use across participants and randomized groups.
- Participants must own (or co-own or lease) an automobile and drive it at least 5000 miles per year (assessed by self-report). The choice of 5,000 miles as cutoff is arbitrary, but will exclude those who do not drive much, and would therefore have less capacity for measureable improvement. People who share the use of a car with no more than one other person but who drive the majority of miles will be included, as will people who own and drive two primary vehicles. People who own and regularly drive more than two vehicles will be excluded due to the added participant and staff burden involved with obtaining odometer readings.
- Ownership, use, and familiarity with a smart phone (either iPhone or Android type) will be required due to planned use of the MOVES app to obtain major outcome data.
- Only one member per household will be allowed to participate.
Who cannot join
- Participants will be excluded if they currently or recently participate in meditative practice or mindfulness or other meditation training in the past 3 years. Assessed by answering "Yes" to any of the following questions: Do you meditate on a regular basis? In the last year, have you meditated at least weekly for 2 or more months in a row? Have you received meditation training in the last 5 years? Have you taken part in a mindfulness class or mindfulness sessions during the past 5 years?
- People with self-described vegan or vegetarian diets (self-assessed average meat ingestion frequency less than once/week) will be excluded, as one goal of the trainings is to influence dietary habits away from meats (especially beef) and towards vegetables and other plant-based foods. Only those who answer "Yes" to "Do you tend to eat at least one meal with some meat in it on most days of the week?" will be eligible to participate.
- People with serious physical, medical, or mental condition precluding adherence to study protocol will be excluded. Questionable cases will be reviewed by the study physicians.
- Those that are unable/unwilling to successfully complete baseline assessment, including in-person meetings, data-collection, and other tasks will be excluded from the study. Inability to complete a sample of the study requirements will indicate an inability to complete full study requirements.
About this study
Official title: Mindful Climate Action: Improving Health While Reducing Carbon Footprint: A Pilot Study
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.
Read the detailed 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. 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.
- Conditions
- Health Behavior
- Being tested
- Mindful Climate Action
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Climate ActionBehavioural
Also called MBSR with Climate Education
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Cohort 1 | Experimental | 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. Receives: Behavioral: Mindful Climate Action |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated carbon footprint
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce Barrett, MD PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007901
- Sponsor's protocol ID
- 2016-1336
- Status last verified
- Jan 2019
- First submitted
- 13 Dec 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28008371
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Climate Action: Improving Health While Reducing Carbon Footprint: A Pilot Study
- ClinicalTrials.gov ID
- NCT03007901
- Acronym / sponsor ID
- 2016-1336
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Cohort 1 | Experimental | Behavioral: Mindful Climate ActionThis 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 30 to 65 years at enrollment will be assessed by self-report and date of birth. This relatively broad age range will facilitate enrollment and will enhance generalizability of results. This range will also tend to include people with moderate to large carbon footprints, possibly allowing room for measurable improvement with mindfulness training.
- Fluency in English (oral, reading, and writing) is necessary to complete all study parameters including: providing consent, completion of questionnaires and online surveys, and intervention objectives.
- Willingness and ability to carry out all study-specific tasks, including commitment to provide data, wear an ActiGraph for one week twice over the course of the study, and be monitored throughout the research study period.
- Participants must be owners (or co-owners) of single family dwelling, and must have been in the same location for the prior 12 months, with no expectation of moving during the study. Utility service to the single family dwelling must be provided by MG\&E (gas and electric) and Madison Water Utility. This is necessary to accurately assess and compare household energy and water use across participants and randomized groups.
- Participants must own (or co-own or lease) an automobile and drive it at least 5000 miles per year (assessed by self-report). The choice of 5,000 miles as cutoff is arbitrary, but will exclude those who do not drive much, and would therefore have less capacity for measureable improvement. People who share the use of a car with no more than one other person but who drive the majority of miles will be included, as will people who own and drive two primary vehicles. People who own and regularly drive more than two vehicles will be excluded due to the added participant and staff burden involved with obtaining odometer readings.
Key exclusion criteria (4 listed)
- Participants will be excluded if they currently or recently participate in meditative practice or mindfulness or other meditation training in the past 3 years. Assessed by answering "Yes" to any of the following questions: Do you meditate on a regular basis? In the last year, have you meditated at least weekly for 2 or more months in a row? Have you received meditation training in the last 5 years? Have you taken part in a mindfulness class or mindfulness sessions during the past 5 years?
- People with self-described vegan or vegetarian diets (self-assessed average meat ingestion frequency less than once/week) will be excluded, as one goal of the trainings is to influence dietary habits away from meats (especially beef) and towards vegetables and other plant-based foods. Only those who answer "Yes" to "Do you tend to eat at least one meal with some meat in it on most days of the week?" will be eligible to participate.
- People with serious physical, medical, or mental condition precluding adherence to study protocol will be excluded. Questionable cases will be reviewed by the study physicians.
- Those that are unable/unwilling to successfully complete baseline assessment, including in-person meetings, data-collection, and other tasks will be excluded from the study. Inability to complete a sample of the study requirements will indicate an inability to complete full study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Climate ActionAlso: MBSR with Climate EducationEducational 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. | Behavioural | Pilot Cohort 1 |
Primary outcome
Estimated carbon footprint
Time frame: 6 months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Background: PubMed 28008371Barrett 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Barrett, MD PhD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Climate Action in people with Health Behavior, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated carbon footprint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03007901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.