- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05889078
The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.
May 25, 2023 updated by: Marie-Claude Geoffroy, McGill University
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H4H 1R3
- Douglas Mental Health University Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- aged 18-25 years
- speaks English
- had working smartphone that can track walk routes using a smartphone application
Exclusion Criteria:
- inability to walk for 45 minutes due to serious medical reasons (eg surgery)
- heart condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nature condition
Participants will walk in a nature setting 3x per week for a period of 4 weeks.
|
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.
|
|
Experimental: Urban condition
Participants will walk in an urban setting 3x per week for a period of 4 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
4 weeks (1x per week for 4 weeks)
|
|
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).
|
4 weeks (1x per week for 4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in baseline depression symptoms at 5 weeks
Time Frame: 5 weeks (1 week following completion of study intervention)
|
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).
|
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)
|
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).
|
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)
|
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).
|
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)
|
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).
|
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)
|
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).
|
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)
|
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).
|
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)
|
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).
|
5 weeks (1 week following completion of study intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 9, 2022
Primary Completion (Estimated)
May 30, 2023
Study Completion (Estimated)
May 30, 2023
Study Registration Dates
First Submitted
May 17, 2023
First Submitted That Met QC Criteria
May 25, 2023
First Posted (Actual)
June 5, 2023
Study Record Updates
Last Update Posted (Actual)
June 5, 2023
Last Update Submitted That Met QC Criteria
May 25, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUSMD-18-33 Phase 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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