NCT02471872

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

5.8 years

First QC Date

June 5, 2015

Last Update Submit

December 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Improvement in Understanding Assessed by Questionnaires

    Assessed immediately after intervention, and at 3 months, 6 months, and 12 months

Study Arms (2)

Air Pollution Education

EXPERIMENTAL

Students are presented with a one-hour interactive information session about air pollution and the environment.

Behavioral: Air Pollution Education

Non-Air Pollution Education

PLACEBO COMPARATOR

Students are presented with a one-hour interactive information session about vaccines.

Other: Non-Air Pollution Education

Interventions

Students are presented with a one-hour interactive session on air pollution.

Air Pollution Education

Students are presented with a one-hour interactive session on vaccines.

Non-Air Pollution Education

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ability to read, write, and understand English at a middle school level
  • Willing to participate in follow up visits

You may not qualify if:

  • Learning disabilities such as autism
  • Moving out of the area in the next 6 months
  • Inability to complete the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine in the Division of Pulmonary, Critical Care, Allergy, Immunology, and Sleep Medicine

Study Record Dates

First Submitted

June 5, 2015

First Posted

June 15, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations