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Environmental ExposureNCT05160948

Change in Knowledge After Receiving Personal Air Pollution Results

An observational study of Environmental Exposure, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Personal exposure to air pollution results from the interaction of individual time-activity patterns with levels of air pollution that vary over time and space. The increasing use of personal monitors capable of measuring geo-located and real-time air pollution in epidemiologic studies requires novel human subject… Read more about this study

Who is it for?
Ages 15 to 99 years
Conditions the study is for
Environmental Exposure
What is being tested?
Informational Report
How many people
105 participants
Where
1 siteUnited States
Study dates
10 Nov 2021to 10 Nov 2022
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 99 years
  • All sexes
  • Child, Adult, Older adult

Study population: All EcoMAPPE participants and their caregivers will be invited to participate in this study. A total of 118 adolescents (age 13-17) were enrolled. Therefore, the sample size of this study is expected to be 236 (participant + caregiver). The sex and race of study participants is anticipated to reflect the enrollment in EcoMAPPE; 44% male, 74% White, 18% Black, and 8% other race.

Who may be able to join

  • All participants must have previously participated in the EcoMAPPE Study as a child or be a parent/legal guardian of a child that participated in EcoMAPPE

Who cannot join

  • Not being a previous EcoMAPPE participant or parent of an EcoMAPPE participant

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Assessing Changes in Knowledge, Behavior, and Attitude Regarding Air Pollution After Receiving Personal Air Monitoring Results

Personal exposure to air pollution results from the interaction of individual time-activity patterns with levels of air pollution that vary over time and space. The increasing use of personal monitors capable of measuring geo-located and real-time air pollution in epidemiologic studies requires novel human subject considerations. Reporting individual exposure data back to participants is considered best practice in environmental health research using biomonitoring data and is beneficial to both study participants and researchers. The investigators believe that providing individual results of personal air monitoring may be more informative than biomonitoring data given the potential to increase participants' awareness of their exposure, identify specific locations and times of elevated exposures, and inform behavioral changes to decrease exposure and risk of adverse health outcomes.

Read the detailed description

Personal exposure to air pollution results from the interaction of individual time-activity patterns with levels of air pollution that vary over time and space. Thus, personal monitors worn by study participants during daily living are considered the "gold-standard" to assess individual-level air pollution exposure. The increasing use of personal monitors capable of measuring geo-located and real-time air pollution in epidemiologic studies requires novel human subject considerations. In contrast with stationary air monitoring or models to estimate air pollution exposure, personal monitors provide a depth of insight and actionable information that is analogous to biological monitoring of chemical exposures. Reporting individual exposure data back to participants is considered best practice in environmental health research using biomonitoring data and is beneficial to both study participants and researchers. The investigators believe that providing individual results of personal air monitoring may be more informative than biomonitoring data given the potential to increase participants' awareness of their exposure, identify specific locations and times of elevated exposures, and inform behavioral changes to decrease exposure and risk of adverse health outcomes. Previously, the investigators enrolled adolescents in our Ecological Momentary Assessment and Personal Particle Exposure (EcoMAPPE) study (IRB #2017-1068) and measured personal exposure to ultrafine particles (UFPs; particulate matter <100 nm in diameter). Recently, the investigators conducted focus groups with a subset of EcoMAPPE participants (n = 16, IRB#: 2019-1003) with the purpose of co-designing information and report-back materials to provide study subjects' their individual results from personal sampling during their participation in the EcoMAPPE study. The overarching hypothesis of this current study is that providing EcoMAPPE participants and their caregivers with the results of their personal air pollution monitoring will increase their awareness and knowledge of their exposure to air pollution and strategies to reduce their exposure. The investigators propose one specific aim as part of this protocol: Aim 1: To increase study participants understanding of air pollution, associated health effects, and engagement with research. All EcoMAPPE participants and their caregivers will be invited to complete a questionnaire to assess their understanding of air pollution and attitudes and beliefs about science and research before and after receiving their individual study air pollution monitoring results collected as part of their participation in EcoMAPPE. All EcoMAPPE participants will be provided with their study results irrespective of their participation in this study.

The investigators will send an email invitation to caregivers of participants enrolled in the EcoMAPPE study. The investigators will also follow-up email invitations by phone call to provide additional information to EcoMAPPE participants and caregivers. Given that participants were ages 13-17 at enrollment, some EcoMAPPE participants are now adults (> 18 years of age) and the investigators will also send an email invitation to participate to those participants. The email will contain information about the current study's objective and methods and a link to complete an electronic consent. The electronic consent will be completed by the participant (for those > 18) or their caregiver (for those < 18). The consent will specify that all EcoMAPPE participants and caregivers will receive their individual results irrespective of participating in this study. Following caregiver consent to participate in the study, participants will receive an invitation to participate and link to an electronic assent.

Following consent and assent, participants and their caregivers will each receive a "Report-Back Pre-Survey" via link to an electronic (Redcap) questionnaire. Participants and caregivers will complete the survey online via Redcap.

Following the completion of the "Report-Back Pre-Survey" caregivers and participants will receive an electronic (html) document containing the results of their EcoMAPPE participation. This report-back document contains information about the EcoMAPPE study, ultrafine particles, and the results of their individual personal sampling. The electronic (html) report-back document will be sent via Redcap.

After downloading and reviewing their personal report back document, participants and caregivers will receive a "Report-Back Post Survey" via link to an electronic REDCap questionnaire (attached). The "Report-Back Post Survey" will be similar to the "Report-Back Post Survey" and will ascertain changes in participants/caregivers attitudes and knowledge regarding air pollution and research.

If necessary (i.e. participant or parent does not have email), consenting and administration of study surveys will be done through an in person visit.

The investigators will compare changes in responses to questions on the Pre and Post Surveys using the paired t-test for questions answered on a 5-point Likert scale.

Being tested
Informational Report
Keywords
Ultrafine particle matter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Informational ReportOther

    All EcoMAPPE participants and their caregivers will be invited to complete a questionnaire to assess their understanding of air pollution and attitudes and beliefs about science and research before and after receiving their individual study air pollution monitoring results collected as part of their participation in EcoMAPPE.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Report-Back Pre/Post Survey

    EcoMAPPE participants and their caregivers will be asked to complete a survey to assess their understanding of air pollution and beliefs about science and research before and after receiving their individual study monitoring results collected as part of their participation in EcoMAPPE. Likert scale questions 'On a scale from 1 to 5, 1=strongly disagree, 2 = disagree, 3 = neither disagree nor agree, 4 = agree, 5 = strongly agree

    Measured: Baseline and within 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start10 Nov 2021
  3. Primary completion10 Nov 2022
  4. Study completion10 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05160948
Sponsor's protocol ID
2021-0707
Other IDs
5R21ES030092-02
Status last verified
Jul 2026
First submitted
1 Dec 2021
Last updated
31 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Environmental Exposure, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Report-Back Pre/Post Survey (time frame: Baseline and within 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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