The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.
Primary Purpose
Affect, Wellness, Psychological, Depressive Symptoms
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
A 4-week walking intervention
Sponsored by
About this trial
This is an interventional other trial for Affect focused on measuring Positive affect, Negative affect, Wellbeing, Walking intervention (nature vs urban), Postsecondary students, Young adults, Stress, Sleep quality, Non-suicidal self-injury, Mindfulness
Eligibility Criteria
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
Sites / Locations
- Douglas Mental Health University Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Nature condition
Urban condition
Arm Description
Participants will walk in a nature setting 3x per week for a period of 4 weeks.
Participants will walk in an urban setting 3x per week for a period of 4 weeks.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05889078
Brief Title
The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.
Official Title
The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Affect, Wellness, Psychological, Depressive Symptoms, Anxiety Disorders and Symptoms, Stress, Sleep, Non-suicidal Self-injury
Keywords
Positive affect, Negative affect, Wellbeing, Walking intervention (nature vs urban), Postsecondary students, Young adults, Stress, Sleep quality, Non-suicidal self-injury, Mindfulness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nature condition
Arm Type
Experimental
Arm Description
Participants will walk in a nature setting 3x per week for a period of 4 weeks.
Arm Title
Urban condition
Arm Type
Experimental
Arm Description
Participants will walk in an urban setting 3x per week for a period of 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
A 4-week walking intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in baseline positive affect at 4 weeks
Description
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).
Time Frame
4 weeks (1x per week for 4 weeks)
Title
Change in baseline negative affect at 4 weeks
Description
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).
Time Frame
4 weeks (1x per week for 4 weeks)
Secondary Outcome Measure Information:
Title
Change in baseline depression symptoms at 5 weeks
Description
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).
Time Frame
5 weeks (1 week following completion of study intervention)
Title
Change in baseline anxiety symptoms at 5 weeks
Description
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).
Time Frame
5 weeks (1 week following completion of study intervention)
Title
Change in baseline perceived stress levels at 5 weeks
Description
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).
Time Frame
5 weeks (1 week following completion of study intervention)
Title
Change in baseline sleep quality at 5 weeks
Description
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).
Time Frame
5 weeks (1 week following completion of study intervention)
Title
Change in baseline mindfulness at 5 weeks
Description
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).
Time Frame
5 weeks (1 week following completion of study intervention)
Title
Change in baseline levels of wellbeing at 5 weeks
Description
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).
Time Frame
5 weeks (1 week following completion of study intervention)
Title
Change in baseline non-suicidal self-injury at 5 weeks
Description
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).
Time Frame
5 weeks (1 week following completion of study intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Douglas Mental Health University Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effects of Walking in Nature (vs. an Urban Setting) on the Wellbeing of Postsecondary Students.
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