CClinicalTrials.gg
CompletedNCT04685681GOUpdated Jul 29, 2022

The Get Outside Study

An interventional study of Hiking challenge and Activity list in Covid19, Risk Reduction and Stress, sponsored by State University of New York at Buffalo. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-29.

Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary aim of this study is to examine whether lower-risk activities displace participation in higher-risk behaviors during COVID-19. Investigators will test this aim by promoting specific activities that are expected to be low-risk when it comes to COVID-19 transmission (e.g., participating in a hiking challenge) and assessing impacts on participants' activity choices. Investigators also aim to describe adults' activity participation during COVID-19 generally and to examine secondary outcomes, including reported stress and sleep.

Read the detailed description

The primary aim of this study is to examine whether lower-risk activities displace participation in higher-risk behaviors during COVID-19. Investigators will test this aim by promoting specific activities that are expected to be low-risk when it comes to COVID-19 transmission and assessing impacts on participants' activity choices.

There will be two study groups, Group 1 and Group 2, each of which will complete 3 online surveys and will be provided with information on lower-risk activities to do during COVID-19. Random assignment to groups will occur after the completion of a baseline survey. Group 1 will receive free access to a local hiking challenge after completing their baseline survey and an information sheet with current CDC-recommended activities after post-test. Group 2 will receive the same resources, but in the opposite order. Therefore, surveys administered at midpoint (\~6 weeks) and post-test (\~12 weeks) will allow for a test of the effects of providing access to the hiking challenge on outcomes of interest.

If participants choose to sign up for the hiking challenge, they receive a list of local hikes/nature walks, accompanying maps, scavenger-hunt-like activities (finding a certain landmark on each hike), and the opportunity to earn prizes and engage with other hikers on social media. The primary outcome will be the activities in which participants engage. An adapted version of the Pleasant Activities list (Koks) will be used to assess activities participants have engaged in during the past 30 days at baseline, midpoint (\~6 weeks), and post-test (\~12 weeks). Current CDC guidance will be used to code activities as lower- and higher-risk anticipating the creation of an aggregate frequency of activities in each of the following categories: activities done outdoors alone or with members of the household (lower risk), activities done indoors alone or with members of the household (lower risk), activities done outdoors with others not in one's household (moderate risk), and activities done indoors with others not in one's household (higher risk). Adults' participation in different types of activities will also be summarized generally, in addition to specific activities of interest (e.g., the lower risk activities that are being targeted, like hiking; and activities that have received attention as being particularly higher risk, like indoor restaurant dining). Investigators will also examine impacts of the provision of the hiking challenge on secondary outcomes, including reported stress and sleep.

The study has the potential to shed light on displacement of higher-risk activities through promotion of lower-risk activities that could serve as substitutes. It also allows for an assessment of the impacts of the local hiking challenge on aspects of well-being. The first cohort of data collection for this study took place between January 2021-April 2021. A replication study was conducted in January 2022-April 2022. The details of the replication study were nearly identical, with one change being the provision of hiking equipment valued at \~$25 (microspikes for the Hiking Challenge intervention group and hiking socks for Activity List controls/the delayed intervention), a modification made based on barriers reported in the original study.

02

Conditions studied

  • Covid19
  • Risk Reduction
  • Stress
  • Sleep

Browse trials for

Keywords

  • Covid19
  • high-risk activities
  • low-risk activities
  • stress
  • sleep
  • adults
03

In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 53 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 years of age or older
  • English speaking
  • Has online access
  • Reports living in Western New York
  • Interested in receiving "suggestions for ways to get outside, stay active, and stay busy" during COVID-19
  • No health problems that preclude participation
  • Not currently involved in regular (at least weekly) hikes/nature walks

Exclusion criteria

Exclusion Criteria:

  • Is under 18 years of age
  • Not English speaking
  • Does not have online access
  • Does not report living in Western New York
  • Is not interested in "suggestions for ways to get outside, stay active, and stay busy" during COVID-19
  • Has health problems precluding participation
  • Is currently involved in regular hikes/nature walks
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Hiking Challenge

    This group receives access to the local hiking challenge after completion of baseline measure

    Behavioral: Hiking challenge

  • Active comparator
    Activity list

    This group receives access to a resource sheet with activity ideas after completion of baseline measure and does not receive the main resource of interest (hiking challenge) until after the post-test (delayed intervention)

    Other: Activity list

Interventions

  • BehavioralHiking challenge

    The main intervention of interest is the provision of free access to a local hiking challenge (which is provided following baseline assessments in the experimental group and after the conclusion of the study in the control group; $20 value). If participants choose to sign up for the free hiking challenge, they receive a list of local hikes/nature walks, accompanying maps, scavenger-hunt-like activities (finding a certain landmark on each hike), and the opportunity to earn prizes and engage with other hikers on social media.

  • OtherActivity list

    The control group will receive a list of CDC-recommended activities following the baseline survey and will receive the hiking challenge as a delayed intervention following post-test.

06

What researchers measure

Primary outcomes

  1. Frequency of lower-risk activities

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. We will aggregate the frequencies of activities that are lower-risk for COVID-19 transmission based on CDC recommendations at the time of the study. We anticipate that two indicators of lower-risk activities will be those completed outdoors by oneself or with individuals in the household and those completed indoors in which only the self or those in the household are present.

    Time frame: Post-test (12 weeks)

  2. Frequency of higher-risk activities

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. We will aggregate the frequencies of activities that are higher-risk for COVID-19 transmission based on CDC recommendations at the time of the study. We anticipate that two indicators of moderate- or high-risk activities will be those completed outdoors with individuals who do not live in one's household (moderate) and those completed indoors with individuals who do not live in one's household (high).

    Time frame: Post-test (12 weeks)

  3. Frequency of social activities

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. We will aggregate the frequencies of activities that are social, both those done with members of the household as well as those done with individuals who do not live in the household with the participant

    Time frame: Post-test (12 weeks)

  4. Frequency of physical activities

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. We will aggregate the frequencies of activities that involve physical activity (e.g., walks, hikes, sports)

    Time frame: Post-test (12 weeks)

  5. Frequency of hiking/nature walks

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. We will examine the frequency indicated for the item: Going on a hike or nature walk

    Time frame: Post-test (12 weeks)

  6. Frequency of restaurant dining

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. We will examine the frequency indicated for the item: Going to a restaurant or café / eating out

    Time frame: Post-test (12 weeks)

Secondary outcomes

  1. Stress

    The 10-item perceived stress scale will be used to assess stress over the past month. Each item is scored from 0-4, for a total possible score of 0-40 (higher score = more stress).

    Time frame: Post-test (12 weeks)

  2. Sleep

    Total nighttime sleep time will come from the Pittsburgh Sleep Quality Index (hours).

    Time frame: Post-test (12 weeks)

Other outcomes

  1. Frequency of lower-risk activities

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. We will aggregate the frequencies of activities that are lower-risk for COVID-19 transmission based on CDC recommendations at the time of the study. We anticipate that two indicators of lower-risk activities will be those completed outdoors by oneself or with individuals in the household and those completed indoors in which only the self or those in the household are present.

    Time frame: Midpoint (6 weeks)

  2. Frequency of lower-risk activities

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. We will aggregate the frequencies of activities that are lower-risk for COVID-19 transmission based on CDC recommendations at the time of the study. We anticipate that two indicators of lower-risk activities will be those completed outdoors by oneself or with individuals in the household and those completed indoors in which only the self or those in the household are present.

    Time frame: Change from baseline to post-test (12 weeks)

  3. Frequency of higher-risk activities

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. We will aggregate the frequencies of activities that are higher-risk for COVID-19 transmission based on CDC recommendations at the time of the study. We anticipate that two indicators of moderate- or high-risk activities will be those completed outdoors with individuals who do not live in one's household (moderate) and those completed indoors with individuals who do not live in one's household (high).

    Time frame: Midpoint (6 weeks)

  4. Frequency of higher-risk activities

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. We will aggregate the frequencies of activities that are higher-risk for COVID-19 transmission based on CDC recommendations at the time of the study. We anticipate that two indicators of moderate- or high-risk activities will be those completed outdoors with individuals who do not live in one's household (moderate) and those completed indoors with individuals who do not live in one's household (high).

    Time frame: Change from baseline to post-test (12 weeks)

  5. Frequency of hiking/nature walks

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. Here we will examine responses to the item about the frequency of hiking or nature walks.

    Time frame: Midpoint (6 weeks)

  6. Frequency of hiking/nature walks

    Participants will indicate the frequency that they complete various activities using an adapted version of the Pleasant Activities List (Koks). Frequencies of each activity are indicated on a 0-4 scale where 0=never in the past 30 days and 4=very often in the past 30 days/more than 1 time per week. For each activity, participants will also indicate if it was done indoors or outdoors and who was there. Here we will examine responses to the item about the frequency of hiking or nature walks.

    Time frame: Change from baseline to post-test (12 weeks)

  7. Stress

    The 10-item perceived stress scale will be used to assess stress over the past month. Each item is scored from 0-4, for a total possible score of 0-40 (higher score = more stress).

    Time frame: Midpoint (6 weeks)

  8. Stress

    The 10-item perceived stress scale will be used to assess stress over the past month. Each item is scored from 0-4, for a total possible score of 0-40 (higher score = more stress).

    Time frame: Change from baseline to post-test (12 weeks)

  9. Sleep

    Total nighttime sleep time will come from the Pittsburgh Sleep Quality Index (hours).

    Time frame: Midpoint (6 weeks)

  10. Sleep

    Total nighttime sleep time will come from the Pittsburgh Sleep Quality Index (hours).

    Time frame: Change from baseline to post-test (12 weeks)

07

Study locations

1 site
  • State University of New York at Buffalo
    Buffalo, New York 14214, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04685681
Lead sponsor
State University of New York at Buffalo
Responsible party
Stephanie Anzman-Frasca (Assistant Professor of Pediatrics, State University of New York at Buffalo) — Principal investigator
First posted
Dec 28, 2020
Start date
Jan 7, 2021
Primary completion
Mar 25, 2022
Completion
Mar 25, 2022
Last update
Jul 29, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion