ClinicalTrials.gg
CompletedNCT05338242Updated Aug 25, 2026Results posted

Monitoring Environmental Exposures and Behavioral Change

An interventional study of Real-Time Exposure Feedback in Risk Reduction, Environmental Exposure and Risk Behavior, Health, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by University of Utah · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Risk Reduction
  • Environmental Exposure
  • Risk Behavior, Health
03

In context

Risk Reduction Behavior

291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.

This study's enrollment of 30 is below the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.

Browse Risk Reduction Behavior studies →

Lead sponsor

University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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.

    Device: Real-Time Exposure Feedback

  • 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.

Interventions

  • DeviceReal-Time Exposure 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From baseline to device removal, up to 3 months

  2. 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.

    Time frame: From baseline to 1-3 months after removal of device, up to 6 months

  3. 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.

    Time frame: From baseline to 3-6 months after removal of device, up to 9 months

07

Results

Posted Aug 25, 2026
Limitations and caveats
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.

Participant flow

Recruitment occurred primarily through word of mouth, posted flyers, booths at local events, and social media announcements.

Participant flow — Overall Study
MilestoneReal-Time FeedbackNo Feedback
Started1311
Post sampling survey48
3 month post survey01
6 month post survey01
Completed01
Not completed1310

Outcome measures

PrimaryBehaviors 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.

Time frame:
From baseline to device removal, up to 3 months
Reported as:
Median · Change in frequency score
Behaviors Related to Reduction in Exposure at Device Removal
Change in frequency scoreReal-Time FeedbackNo Feedback
Behaviors Related to Reduction in Exposure at Device Removal0 (0 to 5)0 (-3 to 5)
PrimaryBehaviors 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.

Time frame:
From baseline to 1-3 months after removal of device, up to 6 months
Reported as:
Median · Change in frequency score
Behaviors Related to Reduction in Exposure 1-3 Months After Device Removal
Change in frequency scoreReal-Time FeedbackNo Feedback
Behaviors Related to Reduction in Exposure 1-3 Months After Device Removal—1 (1 to 1)
PrimaryBehaviors 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.

Time frame:
From baseline to 3-6 months after removal of device, up to 9 months
Reported as:
Median · Change in frequency score
Behaviors Related to Reduction in Exposure 3-6 Months After Device Removal
Change in frequency scoreReal-Time FeedbackNo Feedback
Behaviors Related to Reduction in Exposure 3-6 Months After Device Removal—5 (5 to 5)

Adverse events

Collected over All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Real-Time Feedback———
No Feedback———

Baseline characteristics

Age, Customized
Age, Customized(Participants)Real-Time FeedbackNo FeedbackTotal
Age — <18 years000
Age — >= 18 years131124
Sex: Female, Male
Sex: Female, Male(Participants)Real-Time FeedbackNo FeedbackTotal
Female10919
Male325
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Real-Time FeedbackNo FeedbackTotal
American Indian or Alaska Native131124
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
08

Study locations

1 site
  • University of Utah
    Salt Lake City, Utah 84108, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05338242
Lead sponsor
University of Utah
Responsible party
Darrah Sleeth (Associate Professor, University of Utah) — Principal investigator
First posted
Apr 21, 2022
Start date
Jul 28, 2022
Primary completion
Mar 25, 2024
Completion
Mar 25, 2024
Results posted
Aug 25, 2026
Last update
Aug 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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