- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05338242
Monitoring Environmental Exposures and Behavioral Change
November 27, 2023 updated by: Darrah Sleeth, University of Utah
Environmental Exposures of the Northern Arapaho Tribe: An Exploratory Study
The goal of this study is to examine what effect real-time feedback on particulate matter (PM) air pollution levels has on risk recognition and behavior.
The hypothesis is that real-time exposure feedback will change perceptions of risk and increase behaviors that avoid exposure to environmental risks.
At least one representative household member in participating households will complete a questionnaire to fully understand environmental concerns, risk perceptions, and related behaviors.
Half of the households will have PM monitors that continuously display real-time concentrations and an indication of the hazard level.
The other participants will have the same device but it will only display the date and time.
All participants will then be surveyed again: (a) immediately after sampling is complete (i.e., when the devices are removed from the home), (b) after 3 months and, (c) after 6 months.
The goal of repeated surveys is to determine changing understanding of risks, how participating in research and/or receiving real-time exposure data may have changed participant behavior, and what concerns they continue to have.
The questionnaire will include questions with categorical and/or quantitative answers (e.g., frequency of specific behaviors) so that changes in risk perception and behavior can be effectively analyzed.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Darrah K Sleeth, PhD
- Phone Number: 801-585-3587
- Email: darrah.sleeth@hsc.utah.edu
Study Contact Backup
- Name: Scott Collingwood, PhD
- Phone Number: 801-213-3726
- Email: scott.collingwood@hsc.utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- Recruiting
- University of Utah
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Participants must live in a household where at least one adult is a member of the N. Arapaho tribe who is a Primary Participant in the related exposure assessment study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Real-Time Feedback
Participants will receive real-time exposure monitors that continuously display real-time air concentration information and a color-coded designation for the current risk level.
|
Participants will receive real-time exposure monitors that continuously display real-time air concentration information and a color-coded designation for the current risk level.
|
No Intervention: No Feedback
Participants will have exposure levels monitored by the same device, but it will only display the date/time and will not provide real-time feedback.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behaviors Related to Reduction in Exposure
Time Frame: At removal of device
|
Outcomes will be measured as a change in how often (frequency) behaviors related to reduction in exposure occur
|
At removal of device
|
Behaviors Related to Reduction in Exposure
Time Frame: 3 months after removal of device
|
Outcomes will be measured as a change in how often (frequency) behaviors related to reduction in exposure occur
|
3 months after removal of device
|
Behaviors Related to Reduction in Exposure
Time Frame: 6 months after removal of device
|
Outcomes will be measured as a change in how often (frequency) behaviors related to reduction in exposure occur
|
6 months after removal of device
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2022
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
April 13, 2022
First Submitted That Met QC Criteria
April 13, 2022
First Posted (Actual)
April 21, 2022
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- R21NArapaho
- R21ES032137 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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