Skip to content

Monitoring Environmental Exposures and Behavioral Change

Environmental Exposures of the Northern Arapaho Tribe: An Exploratory Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05338242
Enrollment
30
Registered
2022-04-21
Start date
2022-07-28
Completion date
2024-03-25
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Environmental Exposure, Risk Behavior, Health, Risk Reduction

Brief 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.

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.

Sponsors

University of Utah
Lead SponsorOTHER
National Institute of Environmental Health Sciences (NIEHS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Behaviors Related to Reduction in Exposure at Device RemovalFrom baseline to device removal, up to 3 monthsOutcomes 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 RemovalFrom baseline to 1-3 months after removal of device, up to 6 monthsOutcomes 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 RemovalFrom baseline to 3-6 months after removal of device, up to 9 monthsOutcomes 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.

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

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".

Baseline characteristics

Characteristic
Age, Customized
Age
<18 years
0 Participants
Age, Customized
Age
>= 18 years
24 Participants
Race (NIH/OMB)
American Indian or Alaska Native
13 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Sex: Female, Male
Female
19 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026