AffectNCT05889078
The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.
A study testing A 4-week walking intervention in people with Affect and Wellness, Psychological, run by McGill University at 1 site in Canada.
Trial summary
The goal of this randomized controlled trial is to examine the effects of a walking intervention (3 walks per week for a period of 4 weeks) in a nature vs. urban setting on the wellbeing of young adult postsecondary students. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Affect, Wellness, Psychological, Depressive Symptoms
- What is being tested?
- A 4-week walking intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 9 Nov 2022to 30 May 2023
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-25 years
- speaks English
- had working smartphone that can track walk routes using a smartphone application
Who cannot join
- inability to walk for 45 minutes due to serious medical reasons (eg surgery)
- heart condition
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
About this study
The goal of this randomized controlled trial is to examine the effects of a walking intervention (3 walks per week for a period of 4 weeks) in a nature vs. urban setting on the wellbeing of young adult postsecondary students. We will examine changes in positive and negative affect for participants assigned to the nature condition vs those assigned to the urban condition (primary outcome). We will also examine changes in reported depression and anxiety symptoms, perceived stress levels, sleep quality, mindfulness and wellbeing (secondary outcome).
- Conditions
- Affect, Wellness, Psychological, Depressive Symptoms, Anxiety Disorders and Symptoms, Stress, Sleep
- Being tested
- A 4-week walking intervention
- Keywords
- Positive affect, Negative affect, Wellbeing, Walking intervention (nature vs urban), Postsecondary students, Young adults, Stress, Sleep quality, Non-suicidal self-injury, Mindfulness
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders, Self-Injurious Behavior, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 4-week walking interventionBehavioural
Participants will walk along a predetermined route 3 times per week for a period of 4 weeks, answering a pre- and post-intervention questionnaire as well as weekly questionnaires measuring their affect and other variables related to wellbeing. Participants will be randomly assigned to one of two conditions (nature vs urban setting), determining whether the predetermined route they will walk is in a nature or urban setting.
| Study group | Role | What they receive |
|---|---|---|
| Nature condition | Experimental | Participants will walk in a nature setting 3x per week for a period of 4 weeks. Receives: Behavioral: A 4-week walking intervention |
| Urban condition | Experimental | Participants will walk in an urban setting 3x per week for a period of 4 weeks. Receives: Behavioral: A 4-week walking intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline positive affect at 4 weeks
Measured by the Positive and Negative Affect Schedule. Total scores range from 10-50 for positive affect, with higher scores indicating higher levels of positive affect (a better outcome).
Measured: 4 weeks (1x per week for 4 weeks)
Change in baseline negative affect at 4 weeks
Measured by the Positive and Negative Affect Schedule. Total scores range from 10-50 for negative affect, with higher scores indicating higher levels of negative affect (a worse outcome).
Measured: 4 weeks (1x per week for 4 weeks)
Secondary outcomes (7)
Change in baseline depression symptoms at 5 weeks
Measured by the Patient Health Questionnaire-9 Items (PHQ-9), with total scores ranging from 0-27, with higher scores indicating more depressive symptoms (a worse outcome).
Measured: 5 weeks (1 week following completion of study intervention)
Change in baseline anxiety symptoms at 5 weeks
Measured by the General Anxiety Disorder-7 (GAD-7), with total scores ranging from 0-21, with higher scores indicating greater severity in anxiety symptoms (a worse outcome).
Measured: 5 weeks (1 week following completion of study intervention)
Change in baseline perceived stress levels at 5 weeks
Measured by the Perceived Stress Scale (PSS), with total scores ranging from 0 to 40 with higher scores indicating higher perceived stress (a worse outcome).
Measured: 5 weeks (1 week following completion of study intervention)
Change in baseline sleep quality at 5 weeks
Measured by the Pittsburgh Sleep Quality Index (PSQI), with total scores ranging from 0 to 21 with higher scores indicating worse sleep quality (a worse outcome).
Measured: 5 weeks (1 week following completion of study intervention)
Change in baseline mindfulness at 5 weeks
Measured by the Five Facets of Mindfulness Questionnaire (FFMQ). Each item is rated from 1 = rarely true to 5 = always true. Results comprise a total average score and 5 subscale scores. Average scores are calculated by summing the responses and dividing by the number of items. Higher scores indicate higher levels of mindfulness (a better outcome).
Measured: 5 weeks (1 week following completion of study intervention)
Change in baseline levels of wellbeing at 5 weeks
Measured by the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS), with scores ranging from 14 to 70. Higher scores indicate greater positive mental wellbeing (a better outcome).
Measured: 5 weeks (1 week following completion of study intervention)
Change in baseline non-suicidal self-injury at 5 weeks
We assessed Non-Suicidal Self-Injury using a question previously used with same-aged participants in the Québec Longitudinal Study of Child Development: "Sometimes, some people hurt themselves intentionally, even when they don't have the intention to kill themselves. Over the past two weeks, have you harmed yourself deliberately, without the intention to kill yourself?" rated from 1 = never to 4 = very often. High scores indicate greater frequency of non-suicidal self-injury (a worse outcome).
Measured: 5 weeks (1 week following completion of study intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start9 Nov 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AffectStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Claude Geoffroy, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889078
- Sponsor's protocol ID
- IUSMD-18-33 Phase 2
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.
- ClinicalTrials.gov ID
- NCT05889078
- Acronym / sponsor ID
- IUSMD-18-33 Phase 2
- Conditions
- Affect, Wellness, Psychological, Depressive Symptoms, Anxiety Disorders and Symptoms, Stress, Sleep
- Keywords
- Positive affect, Negative affect, Wellbeing, Walking intervention (nature vs urban), Postsecondary students, Young adults, Stress, Sleep quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 5 Jun 2023 (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 goal of this randomized controlled trial is to examine the effects of a walking intervention (3 walks per week for a period of 4 weeks) in a nature vs. urban setting on the wellbeing of young adult postsecondary students. We will examine changes in positive and negative affect for participants assigned to the nature condition vs those assigned to the urban condition (primary outcome). We will also examine changes in reported depression and anxiety symptoms, perceived stress levels, sleep quality, mindfulness and wellbeing (secondary outcome).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature condition | Experimental | Behavioral: A 4-week walking interventionParticipants will walk in a nature setting 3x per week for a period of 4 weeks. |
| Urban condition | Experimental | Behavioral: A 4-week walking interventionParticipants will walk in an urban setting 3x per week for a period of 4 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 18-25 years
- speaks English
- had working smartphone that can track walk routes using a smartphone application
Key exclusion criteria (2 listed)
- inability to walk for 45 minutes due to serious medical reasons (eg surgery)
- heart condition
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 |
|---|---|---|
| A 4-week walking interventionParticipants will walk along a predetermined route 3 times per week for a period of 4 weeks, answering a pre- and post-intervention questionnaire as well as weekly questionnaires measuring their affect and other variables related to wellbeing. Participants will be randomly assigned to one of two conditions (nature vs urban setting), determining whether the predetermined route they will walk is in a nature or urban setting. | Behavioural | Nature condition, Urban condition |
Primary outcome
Change in baseline positive affect at 4 weeks
Time frame: 4 weeks (1x per week for 4 weeks)
Measured by the Positive and Negative Affect Schedule. Total scores range from 10-50 for positive affect, with higher scores indicating higher levels of positive affect (a better outcome).
Change in baseline negative affect at 4 weeks
Time frame: 4 weeks (1x per week for 4 weeks)
Measured by the Positive and Negative Affect Schedule. Total scores range from 10-50 for negative affect, with higher scores indicating higher levels of negative affect (a worse outcome).
7 secondary outcomes
Change in baseline depression symptoms at 5 weeks
Time frame: 5 weeks (1 week following completion of study intervention)
Change in baseline anxiety symptoms at 5 weeks
Time frame: 5 weeks (1 week following completion of study intervention)
Change in baseline perceived stress levels at 5 weeks
Time frame: 5 weeks (1 week following completion of study intervention)
Change in baseline sleep quality at 5 weeks
Time frame: 5 weeks (1 week following completion of study intervention)
Change in baseline mindfulness at 5 weeks
Time frame: 5 weeks (1 week following completion of study intervention)
Change in baseline levels of wellbeing at 5 weeks
Time frame: 5 weeks (1 week following completion of study intervention)
Change in baseline non-suicidal self-injury at 5 weeks
Time frame: 5 weeks (1 week following completion of study intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 4-week walking intervention in people with Affect and Wellness, Psychological, run by McGill University at 1 site in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Jun 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 Canada. 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?
Results are not available in the source record.
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 baseline positive affect at 4 weeks (time frame: 4 weeks (1x per week for 4 weeks)). The study lists 2 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 5 Jun 2023.