MoodNUWGNCT03950661
Walking Green: The Effects of Walking in Forested and Urban Areas
A study testing Walking in people with Mood and Stress, run by Northwestern University at 1 site in United States.
Trial summary
This research hypothesizes that moderate physical activity in a "green environment" (e.g. a forest preserve path) has increased benefits on psychological measures (stress, anxiety, mood, depression, attention) and on physiological measures (Heart Rate Variability, Blood Glucose, Salivary Cortisol) when directly… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 8 Dec 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- over the age of 18
- under the age of 35
- no current infections / recent infections (<2weeks)
- PAR-Q+ scores indicative of readiness to engage in physical activity
Who cannot join
- Women who are pregnant or breast-feeding
- Inability to consent
- Incarcerated Persons
- non-adults
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Walking Green: The Effects of Walking in Forested and Urban Areas on Health and Well-being
This research hypothesizes that moderate physical activity in a "green environment" (e.g. a forest preserve path) has increased benefits on psychological measures (stress, anxiety, mood, depression, attention) and on physiological measures (Heart Rate Variability, Blood Glucose, Salivary Cortisol) when directly compared to activity in a "gray environment" (urban or suburban sidewalks).
The study design is a randomized crossover design in which each subject is assigned randomly to a group which determines the order in which participants will walk in each location. Subjects will take three 50-minute walks per location in one week, with half of the subjects taking the urban walks first as per group assignment. Control data are collected on days when participants do not walk. Physiological data are taken during walks and control periods (heart rate, heart rate variation). Biomarker samples (saliva, dried blood spots) are taken on selected days. Psychological data are take before and after walks and control periods.
Read the detailed description
This study records the psychological and physiological effects of green vs gray walks during a longitudinal crossover study on 41 participants. In accordance with the Attention Restoration and Stress Recovery theories we hypothesize that exposure to a green environment will have beneficial health outcomes for participants both psychologically (mood, stress, anxiety, depression, attention) and physiologically (blood glucose, heart rate variability, cortisol).
Participants will be randomly assigned to a study group which determines the order in which they will walk in either the gray or green location. The study takes place for 29 days of which only 9 are active study dates. The cross-over design controls for training effects that may result from the regular physical activity. Participants provided informed consent on Day 1. Walks will be monitored on Days 8, 12, 22, 26, while walks on days 10 and 24 have no monitoring to reduce testing burden. Days 15 and 29 are control days in which the participants are monitored during the day (Activities of Daily Living) as a control against the location they had previously walked in. No walks will be taken between days 12 and 21 to provide a washout period from the previous location. Psychological tests are administered by computer using the Qualtrics software platform to assess:
Positive and Negative Affect Scale (PANAS) Center for Epidemiological Studies Depression Scale (CESD) State and Trait Anxiety Inventory (STAI) Cohen's Perceived Stress Scale (UCLA) Perceived Isolation Scale Nature Relatedness Scale (NR-6)
Anthropometric measures are taken on days 1, 8, 15, 22, and 29. Physiological effects are studied through heart rate monitoring during all monitored walks via a Zephyr Omnisense which records heart information as well as activity, temperature and breathing rate. Salivary cortisol is collected on days 7, 14, 21, and 28 by the participant. Blood glucose is measured on days 8, 12, 15, 22, 26, and 29; dried blood spots are collected for future analysis of inflammatory biomarkers.
Hypotheses will be tested using fixed and random effects linear regression models using the appropriate statistical procedures in SAS 9.4 to test for main effects, covariates, and other confounding variables that were measured throughout the study including individuals' reported stress and tiredness, and the weather conditions of the day.
- Conditions
- Mood, Stress, Anxiety, Depression, Obesity, Health Behavior
- Being tested
- Walking
- Keywords
- nature, walk, stress, Green Walking, Physical Activity, Environment, anxiety, mood
- Medical subject headings
- Anxiety Disorders, Depression, Obesity, Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingOther
| Study group | Role | What they receive |
|---|---|---|
| Forest | Experimental | Each subject is exposed to a 50 minute walk in a "green location" at some point during the crossover experiment. The psychological and physiological measurements taken during these walk location weeks are compared to the measurements from the other location. In addition a 'control' day is assigned for each location (ADL). Receives: Other: Walking |
| Urban | Experimental | Each subject is exposed to a 50 minute walk in a "gray location" at some point during the crossover experiment. The psychological and physiological measurements taken during these walk location weeks are compared to the measurements from the other location. In addition a 'control' day is assigned for each location (ADL). Receives: Other: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Effects - Mood
Change in Positive and Negative Affect scale 0 = never, 4 = very often. Higher Positive Affect scores reflect better reported mood scores. Lower Negative Affect Scores reflect better mood scores. Average values based on age
Measured: 29 days
Psychological Effects - Anxiety
change in STAI (STAI-TRAIT anxiety) score based on a Likert scale self reported score. Higher scores indicate a higher level of self-reported anxiety.
Measured: 29 days
Psychological Effects - Attention
change in vBDS (backward digit span) score lower scores indicate a increased inability to properly recall the numbers in the test.
Measured: 29 days
Psychological Effects - Depression
change in CESD score. Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology. Citation: Radloff LS: The CES-D Scale: a self-report depression scale for research in the general population.
Measured: 29 days
Secondary outcomes (4)
Physiological Effects - Blood Glucose
Glucose levels as markers of health and wellness. (mg/dL)
Measured: 29 days
Physiological Effects - Salivary Cortisol
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: 29 days
Physiological Effects - Blood
Pro- and anti-inflammatory cytokine concentrations in blood (pg/mL), as stress typically induces an inflammatory response
Measured: 29 days
Physiological Effects - Heart Rate Variation
changes in HRV is indicative of parasympathetic input (milliseconds), higher HRV correlating to reduced stress.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jun 2016
- Primary completion14 Aug 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross over design. Repeated measures.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Horton, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950661
- Sponsor's protocol ID
- STU00201604
- Acronym
- NUWG
- Status last verified
- May 2023
- First submitted
- 13 May 2019
- Last updated
- 3 May 2023
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Green: The Effects of Walking in Forested and Urban Areas on Health and Well-being
- ClinicalTrials.gov ID
- NCT03950661
- Acronym / sponsor ID
- NUWG / STU00201604
- Conditions
- Mood, Stress, Anxiety, Depression, Obesity, Health Behavior
- Keywords
- nature, walk, stress, Green Walking, Physical Activity, Environment, anxiety, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 15 May 2019 (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.
This research hypothesizes that moderate physical activity in a "green environment" (e.g. a forest preserve path) has increased benefits on psychological measures (stress, anxiety, mood, depression, attention) and on physiological measures (Heart Rate Variability, Blood Glucose, Salivary Cortisol) when directly compared to activity in a "gray environment" (urban or suburban sidewalks).
The study design is a randomized crossover design in which each subject is assigned randomly to a group which determines the order in which participants will walk in each location. Subjects will take three 50-minute walks per location in one week, with half of the subjects taking the urban walks first as per group assignment. Control data are collected on days when participants do not walk. Physiological data are taken during walks and control periods (heart rate, heart rate variation). Biomarker samples (saliva, dried blood spots) are taken on selected days. Psychological data are take before and after walks and control periods.
Detailed description
This study records the psychological and physiological effects of green vs gray walks during a longitudinal crossover study on 41 participants. In accordance with the Attention Restoration and Stress Recovery theories we hypothesize that exposure to a green environment will have beneficial health outcomes for participants both psychologically (mood, stress, anxiety, depression, attention) and physiologically (blood glucose, heart rate variability, cortisol).
Participants will be randomly assigned to a study group which determines the order in which they will walk in either the gray or green location. The study takes place for 29 days of which only 9 are active study dates. The cross-over design controls for training effects that may result from the regular physical activity. Participants provided informed consent on Day 1. Walks will be monitored on Days 8, 12, 22, 26, while walks on days 10 and 24 have no monitoring to reduce testing burden. Days 15 and 29 are control days in which the participants are monitored during the day (Activities of Daily Living) as a control against the location they had previously walked in. No walks will be taken between days 12 and 21 to provide a washout period from the previous location. Psychological tests are administered by computer using the Qualtrics software platform to assess:
Positive and Negative Affect Scale (PANAS) Center for Epidemiological Studies Depression Scale (CESD) State and Trait Anxiety Inventory (STAI) Cohen's Perceived Stress Scale (UCLA) Perceived Isolation Scale Nature Relatedness Scale (NR-6)
Anthropometric measures are taken on days 1, 8, 15, 22, and 29. Physiological effects are studied through heart rate monitoring during all monitored walks via a Zephyr Omnisense which records heart information as well as activity, temperature and breathing rate. Salivary cortisol is collected on days 7, 14, 21, and 28 by the participant. Blood glucose is measured on days 8, 12, 15, 22, 26, and 29; dried blood spots are collected for future analysis of inflammatory biomarkers.
Hypotheses will be tested using fixed and random effects linear regression models using the appropriate statistical procedures in SAS 9.4 to test for main effects, covariates, and other confounding variables that were measured throughout the study including individuals' reported stress and tiredness, and the weather conditions of the day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cross over design. Repeated measures.
| Arm | Type | Receives |
|---|---|---|
| Forest | Experimental | Other: WalkingEach subject is exposed to a 50 minute walk in a "green location" at some point during the crossover experiment. The psychological and physiological measurements taken during these walk location weeks are compared to the measurements from the other location. In addition a 'control' day is assigned for each location (ADL). |
| Urban | Experimental | Other: WalkingEach subject is exposed to a 50 minute walk in a "gray location" at some point during the crossover experiment. The psychological and physiological measurements taken during these walk location weeks are compared to the measurements from the other location. In addition a 'control' day is assigned for each location (ADL). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- over the age of 18
- under the age of 35
- no current infections / recent infections (<2weeks)
- PAR-Q+ scores indicative of readiness to engage in physical activity
Key exclusion criteria (4 listed)
- Women who are pregnant or breast-feeding
- Inability to consent
- Incarcerated Persons
- non-adults
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 |
|---|---|---|
| Walking | Other | Forest, Urban |
Primary outcome
Psychological Effects - Mood
Time frame: 29 days
Change in Positive and Negative Affect scale 0 = never, 4 = very often. Higher Positive Affect scores reflect better reported mood scores. Lower Negative Affect Scores reflect better mood scores. Average values based on age
Psychological Effects - Anxiety
Time frame: 29 days
change in STAI (STAI-TRAIT anxiety) score based on a Likert scale self reported score. Higher scores indicate a higher level of self-reported anxiety.
Psychological Effects - Attention
Time frame: 29 days
change in vBDS (backward digit span) score lower scores indicate a increased inability to properly recall the numbers in the test.
Psychological Effects - Depression
Time frame: 29 days
change in CESD score. Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology. Citation: Radloff LS: The CES-D Scale: a self-report depression scale for research in the general population.
4 secondary outcomes
Physiological Effects - Blood Glucose
Time frame: 29 days
Physiological Effects - Salivary Cortisol
Time frame: 29 days
Physiological Effects - Blood
Time frame: 29 days
Physiological Effects - Heart Rate Variation
Time frame: 29 days
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 3 May 2023.
- 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.
Teresa Horton principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking in people with Mood and Stress, run by Northwestern University 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 4 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 3 May 2023. 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?
Psychological Effects - Mood (time frame: 29 days). The study lists 4 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 3 May 2023.