StressNCT03442998
Walking Green: Developing an Evidence-base for Nature Prescriptions
A study testing Suburban walk and Nature walk in people with Stress and Attention, run by University of Minnesota at 1 site in United States.
Trial summary
The investigators hypothesize that walking on a nature trail will lead to greater reductions in stress and greater improvements in the capacity to direct attention as compared to walking on a suburban sidewalk. Read more about this study
- Who is it for?
- Ages 35 to 59 yearsHealthy volunteers can take part
- What is being tested?
- Suburban walk and Nature walk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2017to 1 Apr 2019
- 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 35 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 35 to 59
- No contraindications to physical activity
- No major chronic diseases or specific medications that would contraindicate exercise or potentially blunt heart rate variation during exercise
Who cannot join
- Cardiovascular disease medication
- Arthritis
- Steroids
- Certain blood pressure medications
- Diabetes
- Cancer
Show all 11Show fewer
- Self-reported depression or anxiety / taking medication for depression or anxiety,
- Outside age range
- Inability to follow schedule including travel to arboretum
- Exceeding physical activity recommendations (250 minutes per week)
- Contraindications to walking
Trial locations and contacts
1 site in 1 country.
United States1 site
Minnesota Landscape Arboretum
Chaska, Minnesota, 55318
About this study
The investigators hypothesize that walking on a nature trail will lead to greater reductions in stress and greater improvements in the capacity to direct attention as compared to walking on a suburban sidewalk.
The effects of walking in these different locations will be measured using physiological and psychological outcomes. The study design is a randomized with-in person cross-over trial. Subjects will take six 50-minute walks, one walk per week for six weeks. Three walks will occur in the urban setting and three in the nature setting. The order of the conditions will be randomly assigned to each subject, so that half of the subjects will complete the urban walks first and half the subjects will complete the nature walks first. There will be a two-week washout period between the two sets of walks. Day of the week will be fixed within person, and walks will occur during the mild weather months. In the case of inclement weather, the weekly walk will be skipped and an additional week will be added to the schedule. Limiting the frequency to one walk per week maximizes feasibility of the protocol and minimizes training effects, with any training effects over time being handled primarily by randomization (condition order is balanced), but also in the statistical analysis.
Read the detailed description
Suburban walks will be mapped out in clean, safe streets with sidewalks within 3 miles of the Arboretum, in Chaska, Minnesota. A loop covering approximately 1.25 miles will be mapped. At a usual walking speed of 20 minutes per mile, a subject will complete ~ 2 loops. Each walk will be timed so that walking speed can be included in the statistical analysis as an important covariate.
Nature Walks will take place at the University of Minnesota Landscape Arboretum, which is part of the College of Food, Agricultural and Natural Resource Sciences at the University of Minnesota. The Arboretum features more than 1,215 acres of natural landscapes with over 12 miles of trails. Subjects in this study will take their nature walks on the Green Heron Pond Trail and adjacent trails that can be connected to create a walking loop of ~1.25 miles, or an out-and-back course, matching the distance of the suburban walk. Heron Pond and its adjacent marsh and bog represent three naturally occurring ecosystems in Minnesota that are part of the state's geologic and landscape heritage. The bog trail passes through the most diverse ecotypes of any Arboretum hike. Oak woods, maple woods and the mosaic of intermingled wetlands along the boardwalk offer rich rewards for birders, school groups and families.
The primary approach to the statistical analysis will be a repeated measures multivariable linear regression model. The outcomes will be the psychological and physiological measures of stress. The primary independent variable of interest is condition (suburban v. nature). The interaction of condition and time (week of the study) provides a formal test of intervention effects (differences between the urban and nature walks). That is, over the time course of the interventions, are there significant differences in the outcomes between the urban and nature walks? Covariates to be evaluated in the models as possible confounders include the order of the conditions (urban first v. nature first), age, gender, body mass index, and overall habitual physical activity. On an exploratory basis, the investigators will test whether these covariates also serve as modifiers of the intervention effect.
- Being tested
- Suburban walk, Nature walk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suburban walkOther
Each subject is tested under the 'suburban' condition. We will compare the stress response and working memory response to walking in the two experimental conditions ((1)response to walking on a nature path and (2) response to walking on an urban sidewalk).
Nature walkOther
Each subject is tested under the 'nature' condition. We will compare the stress response and working memory response to walking in the two experimental conditions ((1)response to walking on a nature path and (2) response to walking on an urban sidewalk).
| Study group | Role | What they receive |
|---|---|---|
| Suburban | Other | Study participants will wall on a suburban sidewalk setting for 50 minutes. Receives: Other: Suburban walk |
| Nature | Other | Study participants will wall on a nature path setting for 50 minutes. Receives: Other: Nature walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability
High frequency heart rate variation using ambulatory heart rate monitors (milliseconds).
Measured: Measurements will be made at baseline one-week before the first walk, immediately before and after each walk, and within three days following the third walk of each condition (nature vs suburban).
Change in Blood Pressure
Blood pressure (mmHg) using a standard blood pressure cuff.
Measured: Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).
Change in Cortisol Dynamics
Diurnal cortisol dynamics measured by salivary cortisol (ug/dl), as the normal drop in cortisol during the day is attenuated by exposure to chronic stress.
Measured: Measurements will be made before each walk of each condition (nature vs suburban).
Change in Cytokine Blood Concentration
Pro- and anti-inflammatory cytokine concentrations in blood (pg/mL), as stress typically induces an inflammatory response. Blood samples are collected by pricking the subject's finger-tip, collecting drops of blood on Protein SaverTMpaper (Whatman) and then drying the blood spots. The dried blood spots (DBS) are frozen and stored until assayed.
Measured: Measurements will be made before each walk of each condition (nature vs suburban).
Change in Attention restoration
The Backward Digit Span test is one of the oldest tests used to evaluate working memory and is used to assess capacity to direct attention (i.e., attention restoration).
Measured: Measurements will be made at baseline one-week before the first walk, immediately before and after each walk, and within three days following the third walk of each condition (nature vs suburban).
Change in CESD
CESD: Stress is strongly associated with depression. To measure depressive symptoms we will use the Center for Epidemiological Studies Depression Scale (CESD). Scores are determined by summing the participants' answers to all 20 items from 1 ("less than 1 day") to 4 ("5-7 days") pre- and post-walk in each intervention location (nature vs suburban).
Measured: Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).
Change in PANAS
PANAS: Stress is associated with decreased positive and increased negative affect (mood). We will measure affect using the Positive and Negative Affect Scale (PANAS).
Scores are determined by summing the participants' answers to all 20 items from 1 ("very slightly or not at all") to 5 ("extremely") pre- and post-walk in each intervention location (nature vs suburban).
Measured: Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).
Change in STAI
Anxiety: Stress is associated with increased levels of anxiety. Anxiety will be measured using the State and Trait Anxiety Inventories (STAI). Scores are determined by summing the participants' answers to all 20 items from 1 ("not at all") to 4 ("frequently so") pre- and post-walk in each intervention location (nature vs suburban).
Measured: Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).
Change in Perceived stress
Perceived stress: Cohen's perceived stress scale (PSS) will be used to measure the extent to which subjects assess the events and situations in their lives to be stressful. Scores are determined by summing the participants' answers to all 10 items from 1 ("never") to 4 ("very often") pre- and post-walk in each intervention location (nature vs suburban).
Measured: Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start14 Jul 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A Pereira, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442998
- Sponsor's protocol ID
- 1703S09101
- Status last verified
- Oct 2019
- First submitted
- 19 Jul 2017
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Green: Developing an Evidence-base for Nature Prescriptions
- ClinicalTrials.gov ID
- NCT03442998
- Acronym / sponsor ID
- 1703S09101
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- 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.
The investigators hypothesize that walking on a nature trail will lead to greater reductions in stress and greater improvements in the capacity to direct attention as compared to walking on a suburban sidewalk.
The effects of walking in these different locations will be measured using physiological and psychological outcomes. The study design is a randomized with-in person cross-over trial. Subjects will take six 50-minute walks, one walk per week for six weeks. Three walks will occur in the urban setting and three in the nature setting. The order of the conditions will be randomly assigned to each subject, so that half of the subjects will complete the urban walks first and half the subjects will complete the nature walks first. There will be a two-week washout period between the two sets of walks. Day of the week will be fixed within person, and walks will occur during the mild weather months. In the case of inclement weather, the weekly walk will be skipped and an additional week will be added to the schedule. Limiting the frequency to one walk per week maximizes feasibility of the protocol and minimizes training effects, with any training effects over time being handled primarily by randomization (condition order is balanced), but also in the statistical analysis.
Detailed description
Suburban walks will be mapped out in clean, safe streets with sidewalks within 3 miles of the Arboretum, in Chaska, Minnesota. A loop covering approximately 1.25 miles will be mapped. At a usual walking speed of 20 minutes per mile, a subject will complete ~ 2 loops. Each walk will be timed so that walking speed can be included in the statistical analysis as an important covariate.
Nature Walks will take place at the University of Minnesota Landscape Arboretum, which is part of the College of Food, Agricultural and Natural Resource Sciences at the University of Minnesota. The Arboretum features more than 1,215 acres of natural landscapes with over 12 miles of trails. Subjects in this study will take their nature walks on the Green Heron Pond Trail and adjacent trails that can be connected to create a walking loop of ~1.25 miles, or an out-and-back course, matching the distance of the suburban walk. Heron Pond and its adjacent marsh and bog represent three naturally occurring ecosystems in Minnesota that are part of the state's geologic and landscape heritage. The bog trail passes through the most diverse ecotypes of any Arboretum hike. Oak woods, maple woods and the mosaic of intermingled wetlands along the boardwalk offer rich rewards for birders, school groups and families.
The primary approach to the statistical analysis will be a repeated measures multivariable linear regression model. The outcomes will be the psychological and physiological measures of stress. The primary independent variable of interest is condition (suburban v. nature). The interaction of condition and time (week of the study) provides a formal test of intervention effects (differences between the urban and nature walks). That is, over the time course of the interventions, are there significant differences in the outcomes between the urban and nature walks? Covariates to be evaluated in the models as possible confounders include the order of the conditions (urban first v. nature first), age, gender, body mass index, and overall habitual physical activity. On an exploratory basis, the investigators will test whether these covariates also serve as modifiers of the intervention effect.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suburban | Other | Other: Suburban walkStudy participants will wall on a suburban sidewalk setting for 50 minutes. |
| Nature | Other | Other: Nature walkStudy participants will wall on a nature path setting for 50 minutes. |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 35 to 59
- No contraindications to physical activity
- No major chronic diseases or specific medications that would contraindicate exercise or potentially blunt heart rate variation during exercise
Key exclusion criteria (11 listed)
- Cardiovascular disease medication
- Arthritis
- Steroids
- Certain blood pressure medications
- Diabetes
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 |
|---|---|---|
| Suburban walkEach subject is tested under the 'suburban' condition. We will compare the stress response and working memory response to walking in the two experimental conditions ((1)response to walking on a nature path and (2) response to walking on an urban sidewalk). | Other | Suburban |
| Nature walkEach subject is tested under the 'nature' condition. We will compare the stress response and working memory response to walking in the two experimental conditions ((1)response to walking on a nature path and (2) response to walking on an urban sidewalk). | Other | Nature |
Primary outcome
Change in Heart Rate Variability
Time frame: Measurements will be made at baseline one-week before the first walk, immediately before and after each walk, and within three days following the third walk of each condition (nature vs suburban).
High frequency heart rate variation using ambulatory heart rate monitors (milliseconds).
Change in Blood Pressure
Time frame: Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).
Blood pressure (mmHg) using a standard blood pressure cuff.
Change in Cortisol Dynamics
Time frame: Measurements will be made before each walk of each condition (nature vs suburban).
Diurnal cortisol dynamics measured by salivary cortisol (ug/dl), as the normal drop in cortisol during the day is attenuated by exposure to chronic stress.
Change in Cytokine Blood Concentration
Time frame: Measurements will be made before each walk of each condition (nature vs suburban).
Pro- and anti-inflammatory cytokine concentrations in blood (pg/mL), as stress typically induces an inflammatory response. Blood samples are collected by pricking the subject's finger-tip, collecting drops of blood on Protein SaverTMpaper (Whatman) and then drying the blood spots. The dried blood spots (DBS) are frozen and stored until assayed.
Change in Attention restoration
Time frame: Measurements will be made at baseline one-week before the first walk, immediately before and after each walk, and within three days following the third walk of each condition (nature vs suburban).
The Backward Digit Span test is one of the oldest tests used to evaluate working memory and is used to assess capacity to direct attention (i.e., attention restoration).
Change in CESD
Time frame: Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).
CESD: Stress is strongly associated with depression. To measure depressive symptoms we will use the Center for Epidemiological Studies Depression Scale (CESD). Scores are determined by summing the participants' answers to all 20 items from 1 ("less than 1 day") to 4 ("5-7 days") pre- and post-walk in each intervention location (nature vs suburban).
Change in PANAS
Time frame: Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).
PANAS: Stress is associated with decreased positive and increased negative affect (mood). We will measure affect using the Positive and Negative Affect Scale (PANAS). Scores are determined by summing the participants' answers to all 20 items from 1 ("very slightly or not at all") to 5 ("extremely") pre- and post-walk in each intervention location (nature vs suburban).
Change in STAI
Time frame: Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).
Anxiety: Stress is associated with increased levels of anxiety. Anxiety will be measured using the State and Trait Anxiety Inventories (STAI). Scores are determined by summing the participants' answers to all 20 items from 1 ("not at all") to 4 ("frequently so") pre- and post-walk in each intervention location (nature vs suburban).
Change in Perceived stress
Time frame: Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).
Perceived stress: Cohen's perceived stress scale (PSS) will be used to measure the extent to which subjects assess the events and situations in their lives to be stressful. Scores are determined by summing the participants' answers to all 10 items from 1 ("never") to 4 ("very often") pre- and post-walk in each intervention location (nature vs suburban).
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 1 Nov 2019.
- 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.
Mark A Pereira, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suburban walk and Nature walk in people with Stress and Attention, run by University of Minnesota at 1 site in United States.
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 3 inclusion and 11 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in Heart Rate Variability (time frame: Measurements will be made at baseline one-week before the first walk, immediately before and after each walk, and within three days following the third walk of each condition (nature vs suburban).). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2019.