NCT05889078

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

May 17, 2023

Last Update Submit

May 25, 2023

Conditions

Keywords

Positive affectNegative affectWellbeingWalking intervention (nature vs urban)Postsecondary studentsYoung adultsStressSleep qualityNon-suicidal self-injuryMindfulness

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    4 weeks (1x per week for 4 weeks)

Secondary Outcomes (7)

  • Change in baseline depression symptoms at 5 weeks

    5 weeks (1 week following completion of study intervention)

  • Change in baseline anxiety symptoms at 5 weeks

    5 weeks (1 week following completion of study intervention)

  • Change in baseline perceived stress levels at 5 weeks

    5 weeks (1 week following completion of study intervention)

  • Change in baseline sleep quality at 5 weeks

    5 weeks (1 week following completion of study intervention)

  • Change in baseline mindfulness at 5 weeks

    5 weeks (1 week following completion of study intervention)

  • +2 more secondary outcomes

Study Arms (2)

Nature condition

EXPERIMENTAL

Participants will walk in a nature setting 3x per week for a period of 4 weeks.

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.

Behavioral: A 4-week walking intervention

Interventions

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.

Nature conditionUrban condition

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18-25 years
  • speaks English
  • had working smartphone that can track walk routes using a smartphone application

You may not qualify if:

  • inability to walk for 45 minutes due to serious medical reasons (eg surgery)
  • heart condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

MeSH Terms

Conditions

Psychological Well-BeingDepressionAnxiety DisordersSelf-Injurious BehaviorSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral SymptomsMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Marie-Claude Geoffroy, assistant professor

Study Record Dates

First Submitted

May 17, 2023

First Posted

June 5, 2023

Study Start

November 9, 2022

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

June 5, 2023

Record last verified: 2023-05

Locations