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
105

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

Click on a node to explore related trials.

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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

July 31, 2026

Completed
Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

December 1, 2021

Results QC Date

August 18, 2023

Last Update Submit

July 7, 2026

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. 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

    Baseline and within 30 days

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

Results Point of Contact

Title
Patrick Ryan
Organization
Cincinnati Children's Hospital

Study Officials

  • Patrick Ryan, PhD

    CCHMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

November 10, 2022

Study Completion

November 10, 2022

Last Updated

July 31, 2026

Results First Posted

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations