Behavioral Research of Environment and Air Pollution Through Education (BREATHE)
Primary Purpose
Attitude to Health, Pollution Related Respiratory Disorder, Health Behavior
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Air Pollution Education
Non-Air Pollution Education
Sponsored by
About this trial
This is an interventional prevention trial for Attitude to Health
Eligibility Criteria
Inclusion Criteria:
- Ability to read, write, and understand English at a middle school level
- Willing to participate in follow up visits
Exclusion Criteria:
- Learning disabilities such as autism
- Moving out of the area in the next 6 months
- Inability to complete the questionnaires
Sites / Locations
- University of California San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Air Pollution Education
Non-Air Pollution Education
Arm Description
Students are presented with a one-hour interactive information session about air pollution and the environment.
Students are presented with a one-hour interactive information session about vaccines.
Outcomes
Primary Outcome Measures
Behavior Change Assessed by Questionnaires
Change in Future Behavior as it Relates to Personal Choices and Support for Policies and Regulations
Secondary Outcome Measures
Improvement in Understanding Assessed by Questionnaires
Improvement in Understanding of Air Pollution and Its Public Health Ramification
Full Information
NCT ID
NCT02471872
First Posted
June 5, 2015
Last Updated
December 11, 2018
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02471872
Brief Title
Behavioral Research of Environment and Air Pollution Through Education
Acronym
BREATHE
Official Title
Behavioral Research of Environment and Air Pollution Through Education (BREATHE Study)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The BREATHE (Behavioral Research of Environment and Air Pollution Through Education) study is a pilot randomized control trial comparing the efficacy of a classroom-based intervention to no intervention in helping middle-school students understand and make behavioral decisions about air pollution. This study is designed to evaluate the effectiveness of the classroom-based intervention on knowledge of air pollution, understanding of air pollution sources, and behavioral choices made to reduce both contributions to air pollution and personal exposure to air pollution.
It has been well established that pollution is a racial and economic issue. Low-income areas with populations of predominantly people of color tend to be those with the highest rates of pollution and the largest particulate exposure. Creation of and exposure to this pollution is a key issue for the health of inhabitants of these areas, and of those in the broader surrounding areas. By developing, and assessing the effectiveness of, the investigators hope that the BREATHE study will give the investigators insights into how to better combat this higher exposure and reduce the health risks for those in high pollution areas.
The study will take place in 4 visits over a period of 12 months. The hypothesis is that the classroom-based intervention will be effective in leading to behaviors that will reduce exposure to air pollution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attitude to Health, Pollution Related Respiratory Disorder, Health Behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Air Pollution Education
Arm Type
Experimental
Arm Description
Students are presented with a one-hour interactive information session about air pollution and the environment.
Arm Title
Non-Air Pollution Education
Arm Type
Placebo Comparator
Arm Description
Students are presented with a one-hour interactive information session about vaccines.
Intervention Type
Behavioral
Intervention Name(s)
Air Pollution Education
Intervention Description
Students are presented with a one-hour interactive session on air pollution.
Intervention Type
Other
Intervention Name(s)
Non-Air Pollution Education
Intervention Description
Students are presented with a one-hour interactive session on vaccines.
Primary Outcome Measure Information:
Title
Behavior Change Assessed by Questionnaires
Description
Change in Future Behavior as it Relates to Personal Choices and Support for Policies and Regulations
Time Frame
Assessed immediately after intervention, and at 3 months, 6 months, and 12 months
Secondary Outcome Measure Information:
Title
Improvement in Understanding Assessed by Questionnaires
Description
Improvement in Understanding of Air Pollution and Its Public Health Ramification
Time Frame
Assessed immediately after intervention, and at 3 months, 6 months, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to read, write, and understand English at a middle school level
Willing to participate in follow up visits
Exclusion Criteria:
Learning disabilities such as autism
Moving out of the area in the next 6 months
Inability to complete the questionnaires
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Behavioral Research of Environment and Air Pollution Through Education
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