NCT04685681

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 7, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

January 7, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

December 7, 2020

Last Update Submit

July 26, 2022

Conditions

Keywords

Covid19high-risk activitieslow-risk activitiesstresssleepadults

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (2)

  • Stress

    Post-test (12 weeks)

  • Sleep

    Post-test (12 weeks)

Other Outcomes (10)

  • Frequency of lower-risk activities

    Midpoint (6 weeks)

  • Frequency of lower-risk activities

    Change from baseline to post-test (12 weeks)

  • Frequency of higher-risk activities

    Midpoint (6 weeks)

  • +7 more other outcomes

Study Arms (2)

Hiking Challenge

EXPERIMENTAL

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

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)

Other: Activity list

Interventions

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.

Hiking Challenge

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.

Activity list

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

December 7, 2020

First Posted

December 28, 2020

Study Start

January 7, 2021

Primary Completion

March 25, 2022

Study Completion

March 25, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations