- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04922697
Educational Intervention for the Promotion of Knowledge and Preventive Health Behaviors Related to Personal Air Pollution Exposure, The Air Study
July 19, 2022 updated by: Fred Hutchinson Cancer Center
Reducing PM2.5 Exposure and Lung Cancer Risk Using Spatial Data Science (The Air Study)
This clinical trial will conduct an educational intervention to promote knowledge of and preventive health behaviors related to personal air pollution exposure.
Air pollution is n ubiquitous environmental exposure that is associated with harmful health effects including lung cancer.
The educational intervention is comprised of 2 educational videos that include information regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure and the use of a wearable air pollution sensor.
The knowledge gained from this study may inform future research that will be designed to promote awareness of air pollution and its health effects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
OUTLINE:
Participants watch 2 educational videos during week 3 regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure. Participants complete questionnaires at weeks 1 and 5.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults 18 years or older: The evidence for personal strategies to reduce air pollution exposure has been focused on adults
- Live in Seattle, WA: The study is designed to focus on Seattle, WA such as using EnviroFlash alerts
- Own a smartphone: The participant requires a smartphone to setup the Flow app for the air pollution sensor
- Not traveling in the near-term: The study is designed to assess air pollution patterns in the local Seattle area
- Leave your home for at least 7 hours per week: Participants will use a wearable air pollution sensor to measure air pollutant levels from indoor and outdoor sources
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prevention (educational videos, questionnaires)
Participants watch 2 educational videos during week 3 regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure.
Participants will use wearable air pollution sensors.
Participants will complete questionnaires at weeks 1 and 5.
|
Complete questionnaires
Watch educational videos and use wearable air pollution sensor
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in knowledge regarding air pollution
Time Frame: At baseline and week 5
|
Will calculate the proportion of the items that were answered correctly.
McNemar's tests will be used to calculate differences in the proportion of participants answering air pollution knowledge items correctly at baseline and at week 5.
|
At baseline and week 5
|
|
Changes in air pollution preventive health behaviors
Time Frame: At baseline and week 5
|
Will calculate summary scores for air pollution preventive health behaviors and paired t-test to determine intervention effectiveness at baseline and at week 5.
|
At baseline and week 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in perceived barriers
Time Frame: At baseline and week 5
|
Summary scores for perceived barriers (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale.
Paired t-tests will determine changes in perceived barriers at baseline and week 5.
|
At baseline and week 5
|
|
Changes in perceived benefits
Time Frame: At baseline and week 5
|
Summary scores for perceived benefits (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale.
Paired t-tests will determine changes in perceived benefits at baseline and week 5.
|
At baseline and week 5
|
|
Changes in perceived susceptibility
Time Frame: At baseline and week 5
|
Summary scores for perceived susceptibility (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale.
Paired t-tests will determine changes in perceived susceptibility at baseline and week 5.
|
At baseline and week 5
|
|
Changes in perceived severity
Time Frame: At baseline and week 5
|
Summary scores for perceived severity (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale.
Paired t-tests will determine changes in perceived severity at baseline and week 5.
|
At baseline and week 5
|
|
Changes in self-efficacy
Time Frame: At baseline and week 5
|
Summary scores for self-efficacy (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale.
Paired t-tests will determine changes in self-efficacy at baseline and week 5.
|
At baseline and week 5
|
|
Changes in cues to action
Time Frame: At baseline and week 5
|
Will calculate frequencies for each cue to action (guided by the Health Belief Model).
McNemar's tests will be used to calculate differences in the proportion of participants regarding each cue to action at baseline and week 5.
|
At baseline and week 5
|
|
Changes in air pollutant levels measured using the Flow 2 personal air quality sensor
Time Frame: At baseline and week 2 vs. week 4 and week 5
|
Paired t-tests will determine changes in air pollutant levels at baseline and week 2 vs. week 4 and week 5.
|
At baseline and week 2 vs. week 4 and week 5
|
|
Intervention feasibility (accessibility)
Time Frame: At week 5
|
Will report descriptive statistics for intervention accessibility based on responses to the relevant questionnaire items at week 5.
|
At week 5
|
|
Intervention feasibility (acceptability)
Time Frame: At week 5
|
Will report descriptive statistics for intervention acceptability based on responses to the relevant questionnaire items at week 5.
|
At week 5
|
|
Intervention feasibility (demand)
Time Frame: At week 5
|
Will report descriptive statistics for intervention demand based on responses to the relevant questionnaire items at week 5.
|
At week 5
|
|
Intervention feasibility (uptake, sensor upload completion)
Time Frame: At baseline through week 5
|
Will report descriptive statistics the proportion of participants completing sensor uploads.
|
At baseline through week 5
|
|
Intervention feasibility (uptake, educational video viewing)
Time Frame: At week 3
|
Will report descriptive statistics for the proportion of viewing educational videos at week 3.
|
At week 3
|
|
Intervention feasibility (uptake, questionnaire completion)
Time Frame: At baseline and week 5
|
Will report descriptive statistics for the proportion of completing the questionnaires at baseline and week 5.
|
At baseline and week 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Trang VoPham, Fred Hutch/University of Washington Cancer Consortium
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2021
Primary Completion (Actual)
January 10, 2022
Study Completion (Actual)
March 5, 2022
Study Registration Dates
First Submitted
June 1, 2021
First Submitted That Met QC Criteria
June 8, 2021
First Posted (Actual)
June 11, 2021
Study Record Updates
Last Update Posted (Actual)
July 21, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG1121435
- NCI-2021-04399 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 10685 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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