Behavioral Research of Environment and Air Pollution Through Education (BREATHE)

Behavioral Research of Environment and Air Pollution Through Education (BREATHE Study)

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.

Study Overview

• Status: Unknown
• Conditions: Health Behavior; Pollution Related Respiratory Disorder; Attitude to Health
• Intervention / Treatment: Behavioral: Air Pollution Education; Other: Non-Air Pollution Education

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Air Pollution Education; Students are presented with a one-hour interactive information session about air pollution and the environment.	Behavioral: Air Pollution Education; Students are presented with a one-hour interactive session on air pollution.
Placebo Comparator: Non-Air Pollution Education; Students are presented with a one-hour interactive information session about vaccines.	Other: Non-Air Pollution Education; Students are presented with a one-hour interactive session on vaccines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior Change Assessed by Questionnaires	Change in Future Behavior as it Relates to Personal Choices and Support for Policies and Regulations	Assessed immediately after intervention, and at 3 months, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Understanding Assessed by Questionnaires	Improvement in Understanding of Air Pollution and Its Public Health Ramification	Assessed immediately after intervention, and at 3 months, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: BREATHE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No