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.
COMPLETED
NA
30 participants
From baseline to device removal, up to 3 months
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
| 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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
No Feedback
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place