Walking Green: Developing an Evidence-base for Nature Prescriptions
1 other identifier
interventional
24
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 14, 2017
CompletedFirst Submitted
Initial submission to the registry
July 19, 2017
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedNovember 1, 2019
October 1, 2019
1.7 years
July 19, 2017
October 30, 2019
Conditions
Outcome Measures
Primary Outcomes (9)
Change in Heart Rate Variability
High frequency heart rate variation using ambulatory heart rate monitors (milliseconds).
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.
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.
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.
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).
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).
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).
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).
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).
Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).
Study Arms (2)
Suburban
OTHERStudy participants will wall on a suburban sidewalk setting for 50 minutes.
Nature
OTHERStudy participants will wall on a nature path setting for 50 minutes.
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cardiovascular disease medication
- Arthritis
- Steroids
- Certain blood pressure medications
- Diabetes
- Cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minnesota Landscape Arboretum
Chaska, Minnesota, 55318, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Pereira, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2017
First Posted
February 22, 2018
Study Start
July 14, 2017
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
November 1, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share