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The Get Outside Study (GO)

Primary Purpose

Covid19, Risk Reduction, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hiking challenge
Activity list
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring Covid19, high-risk activities, low-risk activities, stress, sleep, adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • State University of New York at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hiking Challenge

Activity list

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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.
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).
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
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)
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
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

Secondary Outcome Measures

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

Full Information

First Posted
December 7, 2020
Last Updated
July 26, 2022
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT04685681
Brief Title
The Get Outside Study
Acronym
GO
Official Title
Examining Adults' Activity Choices During COVID-19: The UB GO Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Risk Reduction, Stress, Sleep
Keywords
Covid19, high-risk activities, low-risk activities, stress, sleep, adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hiking Challenge
Arm Type
Experimental
Arm Description
This group receives access to the local hiking challenge after completion of baseline measure
Arm Title
Activity list
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Hiking challenge
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Activity list
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of lower-risk activities
Description
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)
Title
Frequency of higher-risk activities
Description
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)
Title
Frequency of social activities
Description
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)
Title
Frequency of physical activities
Description
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)
Title
Frequency of hiking/nature walks
Description
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)
Title
Frequency of restaurant dining
Description
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 Outcome Measure Information:
Title
Stress
Description
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)
Title
Sleep
Description
Total nighttime sleep time will come from the Pittsburgh Sleep Quality Index (hours).
Time Frame
Post-test (12 weeks)
Other Pre-specified Outcome Measures:
Title
Frequency of lower-risk activities
Description
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)
Title
Frequency of lower-risk activities
Description
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)
Title
Frequency of higher-risk activities
Description
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)
Title
Frequency of higher-risk activities
Description
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)
Title
Frequency of hiking/nature walks
Description
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)
Title
Frequency of hiking/nature walks
Description
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)
Title
Stress
Description
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)
Title
Stress
Description
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)
Title
Sleep
Description
Total nighttime sleep time will come from the Pittsburgh Sleep Quality Index (hours).
Time Frame
Midpoint (6 weeks)
Title
Sleep
Description
Total nighttime sleep time will come from the Pittsburgh Sleep Quality Index (hours).
Time Frame
Change from baseline to post-test (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
State University of New York at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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