Covid19GONCT04685681
The Get Outside Study
A study testing Hiking challenge and Activity list in people with Covid19 and Risk Reduction, run by State University of New York at Buffalo at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Risk Reduction, Stress
- What is being tested?
- Hiking challenge and Activity list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2021to 25 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York at Buffalo
Buffalo, New York, 14214
About this study
Official title: Examining Adults' Activity Choices During COVID-19: The UB GO Study
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.
- Conditions
- Covid19, Risk Reduction, Stress, Sleep
- Being tested
- Hiking challenge, Activity list
- Keywords
- Covid19, high-risk activities, low-risk activities, stress, sleep, adults
- Medical subject headings
- COVID-19, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hiking challengeBehavioural
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.
Activity listOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hiking Challenge | Experimental | This group receives access to the local hiking challenge after completion of baseline measure Receives: Behavioral: Hiking challenge |
| Activity list | Active comparator | 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) Receives: Other: Activity list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-test (12 weeks)
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).
Measured: Post-test (12 weeks)
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
Measured: Post-test (12 weeks)
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)
Measured: Post-test (12 weeks)
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
Measured: Post-test (12 weeks)
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
Measured: Post-test (12 weeks)
Secondary outcomes (2)
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).
Measured: Post-test (12 weeks)
Sleep
Total nighttime sleep time will come from the Pittsburgh Sleep Quality Index (hours).
Measured: Post-test (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start7 Jan 2021
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Anzman-Frasca, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685681
- Sponsor's protocol ID
- STUDY00005101
- Acronym
- GO
- Status last verified
- Jul 2022
- First submitted
- 7 Dec 2020
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anzman-Frasca S, Drozdowsky J, Zayatz C, Holmbeck K. Effects of a randomized controlled hiking intervention on daily activities, sleep, and stress among adults during the COVID-19 pandemic. BMC Public Health. 2023 May 15;23(1):892. doi: 10.1186/s12889-023-15696-7.
PubMed 37189100
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Adults' Activity Choices During COVID-19: The UB GO Study
- ClinicalTrials.gov ID
- NCT04685681
- Acronym / sponsor ID
- GO / STUDY00005101
- Conditions
- Covid19, Risk Reduction, Stress, Sleep
- Keywords
- Covid19, high-risk activities, low-risk activities, stress, sleep, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 28 Dec 2020 (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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hiking Challenge | Experimental | Behavioral: Hiking challengeThis group receives access to the local hiking challenge after completion of baseline measure |
| Activity list | Active comparator | Other: Activity listThis 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Hiking challengeThe 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. | Behavioural | Hiking Challenge |
| Activity listThe 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. | Other | Activity list |
Primary outcome
Frequency of lower-risk activities
Time frame: Post-test (12 weeks)
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.
Frequency of higher-risk activities
Time frame: Post-test (12 weeks)
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).
Frequency of social activities
Time frame: Post-test (12 weeks)
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
Frequency of physical activities
Time frame: Post-test (12 weeks)
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)
Frequency of hiking/nature walks
Time frame: Post-test (12 weeks)
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
Frequency of restaurant dining
Time frame: Post-test (12 weeks)
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
2 secondary outcomes
Stress
Time frame: Post-test (12 weeks)
Sleep
Time frame: Post-test (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Derived from this study: PubMed 37189100Anzman-Frasca S, Drozdowsky J, Zayatz C, Holmbeck K. Effects of a randomized controlled hiking intervention on daily activities, sleep, and stress among adults during the COVID-19 pandemic. BMC Public Health. 2023 May 15;23(1):892. doi: 10.1186/s12889-023-15696-7.
- Individual participant dataSharing planned: No
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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 Hiking challenge and Activity list in people with Covid19 and Risk Reduction, run by State University of New York at Buffalo at 1 site in United States.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 29 Jul 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of lower-risk activities (time frame: Post-test (12 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04685681, which also lists 1 linked publication.
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 29 Jul 2022; AzTrials last refreshed its copy on 1 Nov 2026.