NCT05160948

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

November 10, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 1, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2022

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

December 1, 2021

Last Update Submit

January 20, 2023

Conditions

Keywords

Ultrafine particle matter

Outcome Measures

Primary Outcomes (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. These questions will include Likert scale questions such as, 'On a scale from 1 to 5 (with 1 being 'very little' and 5 being 'a great deal), how much do you know about the health effects of air pollution?'). Other questions relate to how much participants know about the health effects of air pollution and air pollution sources. In addition to their personal monitoring data, the personalized reports will include basic information on particulate air pollution, sources, and reduction strategies. The investigators will compare their responses prior to reviewing their personalized report and their responses after reviewing their report to asses a shift in their awareness and knowledge.

    12 months

Interventions

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.

Eligibility Criteria

Age15 Years - 99 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Study Officials

  • Patrick Ryan, PhD

    CCHMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2021

First Posted

December 16, 2021

Study Start

November 10, 2021

Primary Completion

June 23, 2022

Study Completion

June 23, 2022

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations