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.
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
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.
- Conditions
- Environmental Exposure
- 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.
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.
- First posted16 Dec 2021
- Study start10 Nov 2021
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Patrick Ryan, PhD, Principal investigator, CCHMC
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Changes in Knowledge, Behavior, and Attitude Regarding Air Pollution After Receiving Personal Air Monitoring Results
- ClinicalTrials.gov ID
- NCT05160948
- Acronym / sponsor ID
- 2021-0707
- Conditions
- Environmental Exposure
- Keywords
- Ultrafine particle matter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Posted 31 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Not being a previous EcoMAPPE participant or parent of an EcoMAPPE participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational ReportAll 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. | Other | – |
Primary outcome
Report-Back Pre/Post Survey
Time frame: Baseline and within 30 days
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Ryan, PhD principal investigator
CCHMC
1 site in 1 country: see every site and its status.
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.