NCT05338242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 28, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

1.7 years

First QC Date

April 13, 2022

Last Update Submit

July 19, 2024

Conditions

Risk ReductionEnvironmental ExposureRisk Behavior, Health

Outcome Measures

Primary Outcomes (3)

  • Behaviors Related to Reduction in Exposure

    Outcomes will be measured as a change in how often (frequency) behaviors related to reduction in exposure occur

    At removal of device

  • Behaviors Related to Reduction in Exposure

    Outcomes will be measured as a change in how often (frequency) behaviors related to reduction in exposure occur

    3 months after removal of device

  • Behaviors Related to Reduction in Exposure

    Outcomes will be measured as a change in how often (frequency) behaviors related to reduction in exposure occur

    6 months after removal of device

Study Arms (2)

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.

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.

Interventions

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.

Real-Time Feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Risk Reduction BehaviorHealth Risk Behaviors

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 21, 2022

Study Start

July 28, 2022

Primary Completion

March 25, 2024

Study Completion

March 25, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)