Risk ReductionNCT05338242

Monitoring Environmental Exposures and Behavioral Change

A study testing Real-Time Exposure Feedback in people with Risk Reduction and Environmental Exposure, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Risk Reduction, Environmental Exposure, Risk Behavior, Health
What is being tested?: Real-Time Exposure Feedback
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 28 Jul 2022to 25 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Utah
Salt Lake City, Utah, 84108

Other trials in United States

About this study

Official title: 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.

Conditions: Risk Reduction, Environmental Exposure, Risk Behavior, Health
Being tested: Real-Time Exposure Feedback
Medical subject headings: Risk Reduction Behavior, Health Risk Behaviors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Real-Time Exposure FeedbackDevice
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.

Study groups in NCT05338242
Study group	Role	What they receive
Real-Time Feedback	Experimental	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. Receives: Device: Real-Time Exposure Feedback
No Feedback	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

Behaviors Related to Reduction in Exposure at Device Removal
Outcomes will be measured by units on a scale that describe how often (frequency) behaviors related to reduction in particulate matter exposure occur. Four (4) behaviors were evaluated for frequency of daily (score=1), weekly (score=2), monthly (score=3), yearly (score=4), never (score=5), and not applicable (score=0). These were summed for a final score. The possible score range was from 0 (none of the behaviors were applicable) to 20 (none of the behaviors were ever done). For example, if all four behaviors were done weekly the final score would be 2+2+2+2 = 8. The outcome measure was obtained before and after sampling. The reported outcome measure here is the change in the combined score. Positive change indicates increased frequency of exposure-reduction behaviors.
Measured: From baseline to device removal, up to 3 months
Behaviors Related to Reduction in Exposure 1-3 Months After Device Removal
Outcomes will be measured by units on a scale that describe how often (frequency) behaviors related to reduction in particulate matter exposure occur. Four (4) behaviors were evaluated for frequency of daily (score=1), weekly (score=2), monthly (score=3), yearly (score=4), never (score=5), and not applicable (score=0). These were summed for a final score. The possible score range was from 0 (none of the behaviors were applicable) to 20 (none of the behaviors were ever done). For example, if all four behaviors were done weekly the final score would be 2+2+2+2 = 8. The outcome measure was obtained before and after sampling. The reported outcome measure here is the change in the combined score. Positive change indicates increased frequency of exposure-reduction behaviors.
Measured: From baseline to 1-3 months after removal of device, up to 6 months
Behaviors Related to Reduction in Exposure 3-6 Months After Device Removal
Outcomes will be measured by units on a scale that describe how often (frequency) behaviors related to reduction in particulate matter exposure occur. Four (4) behaviors were evaluated for frequency of daily (score=1), weekly (score=2), monthly (score=3), yearly (score=4), never (score=5), and not applicable (score=0). These were summed for a final score. The possible score range was from 0 (none of the behaviors were applicable) to 20 (none of the behaviors were ever done). For example, if all four behaviors were done weekly the final score would be 2+2+2+2 = 8. The outcome measure was obtained before and after sampling. The reported outcome measure here is the change in the combined score. Positive change indicates increased frequency of exposure-reduction behaviors.
Measured: From baseline to 3-6 months after removal of device, up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202225 Mar 2024

First posted21 Apr 2022
Study start28 Jul 2022
Primary completion25 Mar 2024
Study completion25 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Risk ReductionStudies of the same condition, open and under way.
More trials run by University of UtahThe sponsor's other registered studies.
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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05338242
Sponsor's protocol ID: R21NArapaho
Other IDs: R21ES032137
Status last verified: Jul 2026
First submitted: 13 Apr 2022
Last updated: 25 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Environmental Exposures of the Northern Arapaho Tribe: An Exploratory Study
ClinicalTrials.gov ID: NCT05338242
Acronym / sponsor ID: R21NArapaho
Conditions: Risk Reduction, Environmental Exposure, Risk Behavior, Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Collaborators: National Institute of Environmental Health Sciences (NIEHS)
Study start: 28 Jul 2022 (actual)
Primary completion: 25 Mar 2024 (actual)
Study completion: 25 Mar 2024 (actual)
First posted: 21 Apr 2022 (actual)
Results: Posted 25 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Real-Time Feedback	Experimental	Device: Real-Time Exposure FeedbackParticipants 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 Feedback	No intervention	–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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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
Real-Time Exposure FeedbackParticipants will receive real-time exposure monitors that continuously display real-time air concentration information and a color-coded designation for the current risk level.	Device	Real-Time Feedback

Primary outcome

Behaviors Related to Reduction in Exposure at Device Removal
Time frame: From baseline to device removal, up to 3 months
Outcomes will be measured by units on a scale that describe how often (frequency) behaviors related to reduction in particulate matter exposure occur. Four (4) behaviors were evaluated for frequency of daily (score=1), weekly (score=2), monthly (score=3), yearly (score=4), never (score=5), and not applicable (score=0). These were summed for a final score. The possible score range was from 0 (none of the behaviors were applicable) to 20 (none of the behaviors were ever done). For example, if all four behaviors were done weekly the final score would be 2+2+2+2 = 8. The outcome measure was obtained before and after sampling. The reported outcome measure here is the change in the combined score. Positive change indicates increased frequency of exposure-reduction behaviors.
Behaviors Related to Reduction in Exposure 1-3 Months After Device Removal
Time frame: From baseline to 1-3 months after removal of device, up to 6 months
Outcomes will be measured by units on a scale that describe how often (frequency) behaviors related to reduction in particulate matter exposure occur. Four (4) behaviors were evaluated for frequency of daily (score=1), weekly (score=2), monthly (score=3), yearly (score=4), never (score=5), and not applicable (score=0). These were summed for a final score. The possible score range was from 0 (none of the behaviors were applicable) to 20 (none of the behaviors were ever done). For example, if all four behaviors were done weekly the final score would be 2+2+2+2 = 8. The outcome measure was obtained before and after sampling. The reported outcome measure here is the change in the combined score. Positive change indicates increased frequency of exposure-reduction behaviors.
Behaviors Related to Reduction in Exposure 3-6 Months After Device Removal
Time frame: From baseline to 3-6 months after removal of device, up to 9 months
Outcomes will be measured by units on a scale that describe how often (frequency) behaviors related to reduction in particulate matter exposure occur. Four (4) behaviors were evaluated for frequency of daily (score=1), weekly (score=2), monthly (score=3), yearly (score=4), never (score=5), and not applicable (score=0). These were summed for a final score. The possible score range was from 0 (none of the behaviors were applicable) to 20 (none of the behaviors were ever done). For example, if all four behaviors were done weekly the final score would be 2+2+2+2 = 8. The outcome measure was obtained before and after sampling. The reported outcome measure here is the change in the combined score. Positive change indicates increased frequency of exposure-reduction behaviors.

Results and safety

Results posted to the registry on 25 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Real-Time Feedback	13	0
No Feedback	11	1

Primary outcome: Behaviors Related to Reduction in Exposure at Device Removal

Time frame: From baseline to device removal, up to 3 months. Median (Full Range). Unit: Change in frequency score

Measure	Real-Time Feedback n = 4	No Feedback n = 8
Value	0 (0 to 5)	0 (-3 to 5)

Population analysed: There was substantial attrition following monitor placement, with many participants not filling out follow up surveys despite many attempts.

Primary outcome: Behaviors Related to Reduction in Exposure 1-3 Months After Device Removal

Time frame: From baseline to 1-3 months after removal of device, up to 6 months. Median (Full Range). Unit: Change in frequency score

Measure	Real-Time Feedback n = 0	No Feedback n = 1
Value	–	1 (1 to 1)

Population analysed: Participants were very difficult to obtain repeated surveys on.

Primary outcome: Behaviors Related to Reduction in Exposure 3-6 Months After Device Removal

Time frame: From baseline to 3-6 months after removal of device, up to 9 months. Median (Full Range). Unit: Change in frequency score

Measure	Real-Time Feedback n = 0	No Feedback n = 1
Value	–	5 (5 to 5)

Population analysed: Participants were very difficult to obtain repeated surveys on.

Adverse events

Time frame: All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Real-Time Feedback	0 of 0	0 of 0	0
No Feedback	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): A major limitation was the small sample size, which reduced the statistical power to detect changes in exposure reduction behavior. Although communication was effective with the CAB and tribal leaders, recruiting potential participants proved challenging. Once they completed the initial activities, it was also difficult to obtain follow-up surveys 3+ months later. Understanding the best format for communicating with this population of participants will be necessary for future work.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Real-Time Exposure Feedback in people with Risk Reduction and Environmental Exposure, run by University of Utah 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?

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 25 Aug 2026. 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?

Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Behaviors Related to Reduction in Exposure at Device Removal (time frame: From baseline to device removal, up to 3 months). The study lists 3 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 NCT05338242.

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 25 Aug 2026.