The Get Outside Study

Covid19 Clinical Trial

— GO  

Official title:

Examining Adults' Activity Choices During COVID-19: The UB GO Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685681
• Other study ID #: STUDY00005101
• Status: Completed
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: March 25, 2022

Study information

• Verified date: July 2022
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 25, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Risk Reduction
• Sleep
• Stress

Intervention

Behavioral:
• Hiking 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.

Other:
• Activity 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.

Locations

Country	Name	City	State
United States	State University of New York at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Midpoint (6 weeks)
Other	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.	Change from baseline to post-test (12 weeks)
Other	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).	Midpoint (6 weeks)
Other	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).	Change from baseline to post-test (12 weeks)
Other	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.	Midpoint (6 weeks)
Other	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.	Change from baseline to post-test (12 weeks)
Other	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).	Midpoint (6 weeks)
Other	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).	Change from baseline to post-test (12 weeks)
Other	Sleep	Total nighttime sleep time will come from the Pittsburgh Sleep Quality Index (hours).	Midpoint (6 weeks)
Other	Sleep	Total nighttime sleep time will come from the Pittsburgh Sleep Quality Index (hours).	Change from baseline to post-test (12 weeks)
Primary	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.	Post-test (12 weeks)
Primary	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).	Post-test (12 weeks)
Primary	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	Post-test (12 weeks)
Primary	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)	Post-test (12 weeks)
Primary	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	Post-test (12 weeks)
Primary	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	Post-test (12 weeks)
Secondary	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).	Post-test (12 weeks)
Secondary	Sleep	Total nighttime sleep time will come from the Pittsburgh Sleep Quality Index (hours).	Post-test (12 weeks)