Trial Outcomes & Findings for Monitoring Environmental Exposures and Behavioral Change (NCT NCT05338242)

NCT ID: NCT05338242

Last Updated: 2026-08-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

From baseline to device removal, up to 3 months

Results posted on

2026-08-25

Participant Flow

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

Once an individual signed the informed consent, they were considered enrolled in the study. However, before assignment to one of the study arms, an initial questionnaire was required to get a baseline assessment. Once that was complete, the participant was randomized to receive 1 of 2 different kits of sampling equipment. There was some drop-out after consent and before assignment, which is why there is a discrepancy between "Enrollment" and "Started".

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
13
11
Overall Study
Post Sampling Survey
4
8
Overall Study
3 month Post Survey
0
1
Overall Study
6 month Post Survey
0
1
Overall Study
COMPLETED
0
1
Overall Study
NOT COMPLETED
13
10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Monitoring Environmental Exposures and Behavioral Change

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Real-Time Feedback
n=13 Participants
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 Feedback
n=11 Participants
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.
Total
n=24 Participants
Total of all reporting groups
Age, Customized
Age · <18 years
0 Participants
n=31 Participants
0 Participants
n=49 Participants
0 Participants
n=80 Participants
Age, Customized
Age · >= 18 years
13 Participants
n=31 Participants
11 Participants
n=49 Participants
24 Participants
n=80 Participants
Sex: Female, Male
Female
10 Participants
n=31 Participants
9 Participants
n=49 Participants
19 Participants
n=80 Participants
Sex: Female, Male
Male
3 Participants
n=31 Participants
2 Participants
n=49 Participants
5 Participants
n=80 Participants
Race (NIH/OMB)
American Indian or Alaska Native
13 Participants
n=31 Participants
11 Participants
n=49 Participants
24 Participants
n=80 Participants
Race (NIH/OMB)
Asian
0 Participants
n=31 Participants
0 Participants
n=49 Participants
0 Participants
n=80 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=31 Participants
0 Participants
n=49 Participants
0 Participants
n=80 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=31 Participants
0 Participants
n=49 Participants
0 Participants
n=80 Participants
Race (NIH/OMB)
White
0 Participants
n=31 Participants
0 Participants
n=49 Participants
0 Participants
n=80 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=31 Participants
0 Participants
n=49 Participants
0 Participants
n=80 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=31 Participants
0 Participants
n=49 Participants
0 Participants
n=80 Participants

PRIMARY outcome

Timeframe: From baseline to device removal, up to 3 months

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

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.

Outcome measures

Outcome measures
Measure
Real-Time Feedback
n=4 Participants
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 Feedback
n=8 Participants
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.
Behaviors Related to Reduction in Exposure at Device Removal
0 Change in frequency score
Interval 0.0 to 5.0
0 Change in frequency score
Interval -3.0 to 5.0

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure
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.
No Feedback
n=1 Participants
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.
Behaviors Related to Reduction in Exposure 1-3 Months After Device Removal
1 Change in frequency score
Interval 1.0 to 1.0

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure
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.
No Feedback
n=1 Participants
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.
Behaviors Related to Reduction in Exposure 3-6 Months After Device Removal
5 Change in frequency score
Interval 5.0 to 5.0

Adverse Events

Real-Time Feedback

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Feedback

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Darrah Sleeth

University of Utah

Phone: 801-585-3587

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place