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

Demographics:

Demographic information (date of birth, gender, race, family income) will be recorded at Visit 1.

Clinical Laboratory Measurements:

Not applicable.

Participants will be asked to complete a total of three in-person visits and one at-home over a period of at least 12 months.

Acquisition of Informed Consent: Parents/guardians of students who meet the eligibility criteria will be sent a set of papers containing:

• A letter explaining the purpose and methods of the study, and
• A letter of consent and assent for both the parent and student to sign.

All documents will be written in simple English and Spanish (<8th grade level). These forms will be brought to school, and those students with completed consent/assent forms will be eligible to participate in the study.

To ensure understanding of the consent and assent material, study staff will review the consent document over the phone with the potential subjects/ guardian.

Questionnaire : The enrolled students will complete a survey (15 multiple-choice questions; five targeting understanding (score range 5-20); ten targeting behavioral choices (score range 10-38)) designed to evaluate their understanding and predict their future behavior towards air pollution immediately before the intervention.

Teaching session : participants will be given a one-hour script-based teaching on either the effects of air pollution on lung health (intervention group) or the role of vaccination in public health (control group). The teaching session also includes offering students to breathe through a straw and also undergo spirometry.

Questionnaire : The enrolled students will complete the same survey immediately after the intervention.

Questionnaire : The enrolled students will complete the same survey in about three months after the intervention.

Questionnaire : The enrolled students will complete the same survey in about six months after the intervention.

Questionnaire: The enrolled students will complete the same survey in about twelve months after the intervention.

Data will be collected, entered into a database, and analyzed using statistical software. The distribution of the data, and the appropriate statistical measures will be calculated. The questionnaire scores before and after the teaching sessions will be compared using paired-t-test. In addition, multivariable regression analysis will be performed to determine whether or not the independent variable is predictive of the outcome and to determine the contribution of covariates.

Sample size:

For sample size and power calculation, we made the following assumptions:

• Minimally important difference in questionnaire score of 10% change due to the intervention.
• Standard deviation of change in score of 40%.
• A drop-out rate of about 20% due to factoring including movement of subjects out of the area. A sample size of 504 subjects (252 subjects in each group) will provide a power of 80% to detect a change in questionnaire score by t-test with a two-sided type I error of 0.05. Considering the drop-out rate, we proposed to recruit a total of 600 subjects (300 in each group).

Measured variables.

Independent variable

• One hour teaching session about air pollution and climate change

Dependent Variables

• Behavior domain score (primary outcome).
• Total domain score (secondary outcome).
• Understanding domain score (secondary outcome)

Covariates

• Age
• Sex
• Income level
• Race
• Ethnicity
• Assigned classrooms.

Statistical Models

• Paired t-test comparison of pre versus post teaching session.
• Linear regression modeling analysis will be performed to compare the scores and change in them between the intervention and control group with adjustment for covariates including age, sex, race, ethnicity, income level, and assigned classrooms as appropriate.
• Multivariate generalized estimating equation regression analysis will be performed to determine whether there is an incremental effect from “time” on scores and change in scores with adjustment for covariates including age, sex, race, ethnicity, income level, and assigned classrooms as appropriate.

Interim Analysis

The progress of the trial will be monitored as detailed in Data Safety and Monitoring Plan. An interim analysis to evaluate the reliability and validity of the study instrument, the survey questionnaire will be performed.

Medical Monitoring

Internally, the investigator and co-investigator will perform the quarterly safety reviews. Externally, a Data Safety and Monitoring Board (DSMB) has been created to evaluate the study with respect to the following:

• Participant safety, burden, confidentiality, and any other matter pertaining to protection of study subjects.
• Quality control, including follow-up for events, and Study productivity in terms of significant research results in addressing the primary study aims. The DSMB members will include two senior investigators not directly involved with the study.

A	B	C	D	E
SCORING OF THE QUESTIONNAIRE: 58 TOTAL POSSIBLE POINTS - 20 in Understanding, 38 in Future Behavior
Number	Domain	Question	Value	Possible Response
Q1	Ustdg	What do you think makes our air polluted?	1	Acid Rain
			1	Trees releasing CO2
			4	Cars and factories releasing smoke and fumes
			1	I don't know
Q2	Ustdg	Which one of the following does NOT contribute to air pollution?	1	Wood burning fire places
			3	Hybrid (gasoline-electric) cars such as Toyota Prius
			1	Landfills
			4	Recycling
			1	Farmers and livestock
			1	Smoking tobacco
Q3	Ustdg	What makes you think the air around you is clean?	1	I don't smell pollution in the air
			1	I don't see smog in the air
			1	I can breathe the air in
			4	None of the above; air pollution may be odorless, invisible
Q4	Ustdg	How do you think air pollution affects your body	2	Air pollution makes it harder for you to breathe.
			3	Air pollution makes it harder for you to breathe, and it damages your lung tissue.
			4	Air pollution makes it harder for you to breathe, it damages your lung tissue, and it could cause lung diseases like asthma.
			1	I do not think air pollution affects my body.
Q5	Ustdg	How do you think air pollution affects the health of your family and community?	1	Air pollution has no real effects on my health.
			2	b. Air pollution has some effects, but they aren’t very important.
			3	c. Air pollution would have big effects on my health, but my community is not polluted.
			4	d. Air pollution has major effects on my family and my community’s health.
Q6	Behvr	How concerned are you about air pollution?	1	Not very - it doesn’t really affect me.
			2	b. Somewhat - I know it’s there, but I think there are more serious issues to worry about.
			3	c. Moderately - I would like to take some steps to decrease air pollution.
			4	d. Very - I am passionate about air pollution and would like to take as many steps as possible to reduce it.
Q7	Behvr	How much do you take air pollution into account when choosing your daily activities?	1	Not at all - it's not something I really worry or think about.
			2	b. Somewhat - I worry about it sometimes, but I don't usually choose differently to avoid pollution.
			3	c. Moderately - I think about it often, and sometimes choose to do something else to avoid pollution.
			4	d. Very - I think about it a lot, and I choose to avoid pollution as much as I can.
Q8	Behvr	It's Friday and you want to go to the movie theater to hang out, but it's too far to walk. What would you do? (Pretend you own a bike, money for the bus, and your parents are home to drive you around)	1	Have my parents drop me off.
			3	b. Bike.
			4	c. Walk. I like walking even if it's far.
			2	d. Take the bus/BART.
			2	e. Carpool with friend(s).
Q9	Behvr	Would you rather buy food that is…	2	Nearby, but more expensive
			1	b. Farther away but cheaper
			1	c. No preference
Q10	Behvr	Do you care about the environment?	4	I care about the environment and I would change my behaviors to protect it.
			1	I care about the environment, but I don’t really want to change my behaviors.
			2	I care about the environment, but I don’t know how to change my behaviors to protect it.
			3	I care about the environment, but I don’t have the money or time to change my behaviors.
			1	I do not care about the environment.
Q11	Behvr	In the past two months, what current events regarding the environment have you read about on your own/outside of class? Include as many examples as you can think of.	1	no answer/irrelevant answer
			4	any current event(s) stated
Q12	Behvr	In the past 6 months, how many times have you walked, biked, or taken public transportation to school instead of driven?	1	Never
			1	A few times
			2	Several times
			3	Almost every day
			4	Every day
Q13	Behvr	In the past 6 months, how many times have you told an adult what you know about the health effects of air pollution?	1	Never
			1	A few times
			2	Several times
			3	Almost every day
			4	Every day
Q14	Behvr	What are some steps you currently take to help the environment?	1	no answer/irrelevant answer
			3	only 1 answer
			4	2 or more examples
Q15	Behvr	What (if any) new steps would you like to try to improve air quality?	1	no answer/irrelevant answer
			4	at least one new behavior

BREATHE INTERVENTION SCRIPT

BREATHE Intervention Script Intervention Script

Slide 1

everyone/anyone: Hello, I’m ________

next person: I’m _________

third person: I’m _________, and we’re here to talk to you about air pollution and its effects on

you.

Slide 2 – Chemistry of Air Pollution n

So what exactly is air pollution? Would anyone like to give some possibilities? (pick a few answers) You’re all very close/correct/essentially correct – air pollution is composed of harmful chemicals and small particles. How this pollution is made is that vapors, gas, dust, and fumes (or VGDF) from many sources mix in the air. A combination of radiation, heat, and the oxygen in our atmosphere oxidize these different materials, creating gases like carbon monoxide and sulfur dioxide that are easy to inhale and harmful for your body.

Slide 3 – Air pollution is a local problem

Air pollution is a problem, even around us. The different colors make up the Air Quality Index that tells us how clean or polluted the air is. Areas that are green mean the air quality conditions pose little risk. As we gradually go from yellow to orange to red, the quality of the air becomes worse. As we can see in the maps, in California, sometimes the air quality is good, like in the picture on the

right, but sometimes it is fairly bad, like in the picture on the right. The variation in air quality can be dangerous for those with sensitive lungs, or people in general.

(Let’s see what air pollution is like in your area! To do this we’re going to use a tool called AirCompare. Let’s bring it up now. [bring up website http://www.epa.gov/aircompare/compare.htmm) on screen]

First let’s select our state - California. Now let’s select the counties we want to compare - let’s start with San Francisco County. What other county(ies) do you want to compare it to? - what counties do you live in? What counties do your friends and/or family live in?

Now that we have our counties selected, let’s click ‘Compare My Air.’

Now all of these counties have a similar number of days that are unhealthy from a general perspective, but what happens when we compare them based on days that are unhealthy for those with asthma or lung conditions? [click the link to do that] Now the differences in air quality are a lot clearer…but what does this mean for people who breathe in that air? [click ‘Learn more about the AQI… link] As we can see, pollutants can hurt people who have sensitive lungs from conditions

like asthma or emphysema (code orange), and those who do not have any lung problems (code red).)

Slide 4 – Air pollution is a global problem m

But air pollution isn’t just concentrated in these cities, or just in California for that matter! Air pollution is a global problem. What do we mean by that, and how do we know? [play video]

(while video is playing…) In this video, we are looking at the circulation of different materials and compounds in the air. (point to each color as you describe it) Red and yellow is dust, green is organic and black carbon, white is sulfates, and blue is sea salt.

Take a few seconds to watch the video. As we can see from the moving colors, even if a

material, like dust, starts in one part of the globe (like china), it is quickly blown to other countries and even continents (follow red air eastward from China to the US)

Slide 5 – Exposure-related Lung Diseases (go through images)

And this air pollution can lead to (skip a beat) exposure-related lung diseases, exposure-related lung diseases , which, like air pollution, are increasingly recognized as a growing global problem. The lung is constantly exposed to various environmental pollutants generated from a variety of sources, which interact with airways and alveoli and result in inflammation, injury, and disease.

Slide 6

Damage to the lungs can lead to serious problems with our body, causing coughing, asthma, chronic (long time) lung diseases, and even death.  Also, pollution causes inflammation in your heart system as well, causing stroke and cardiovascular disease. And the World Health Organization estimates that pollution kills 7 MILLION people per year.

Slide 7 – What is air pollution doing to your body?

What is air pollution doing to your body? It contributes to obstructed lung diseases, such as asthma and emphysema asthma and emphysema , which is a condition in which the air sacs of the lungs are damaged, making it hard to breathe.

Slide 8 – Impact of Asthma in Your Body y

Today we will talk a little bit about asthma. While a normal airway has plenty of space for air to pass through, and is nice and smooth, during an asthma attack, the airway becomes inflamed d, which narrows the amount of space air has to pass through. In addition, sometimes the airway produces a thick and sticky mucus s, which also makes it difficult for air to pass through. This means it is very hard to breath h during an asthma attack.

Slide 8 – Quick Check k

Before we move on, let’s see how much you all remember. What is one symptom of asthma? Any ideas? [call on raised hands] Yes and? …Which causes…? Correct! Asthma can cause an inflamed airway, mucus in the airway, and ultimately difficulty breathing.

Slide 10 – How can we observe this?

How can we see and study these effects of air pollution on our body?

We use a special tool called (click) a bronchoscope. This is a tube, with a camera and light, which is inserted into your lungs and then used to view (click) the airways! So while we may not be able to see anything on the outside when someone is being harmed by air pollution, we can still see the impact on their lungs. And we can measure lung health without needing a bronchoscopy – we use a test called spirometry !

ACTIVITY 1 - spirometry y

Slide 11 – What is air pollution doing to your body?

[ perform animation ]

This is an image of a healthy airway, which is not inflamed. perform animation] On the other hand, this is an inflamed airway. As you can see, there is a lot less space for air to pass through the lungs because the alveol are irritated. This makes breathing difficult because the oxygen has a harder time entering the blood.

Slide 12 – How is this impacting you personally?

ACTIVITY 2!

We will now use straw(s) to demonstrate the effects of pollution on our airways. If anyone has asthma or other respiratory problems, please skip this activity and just watch and learn from your classmates or share your thoughts with them.

Slide 13 – Timer

To start off, we’re all going to stand up. When we tell you to start, you’re going to hop up and down for 30 seconds. Everybody ready? Go!

How did that feel?

For this next part of the activity, we will give you each a straw, and while we are handing out straws, please stand up. When we tell you to go, you'll start hopping up and down, while breathing in and out ONLY through the straw. We will do this for 30 seconds, then we’ll tell you to stop.

Everyone ready?

Slide 13 – Timer r

Okay, go! Start hopping!

How did that feel? Was it easy? Hard? [ wait for responses ]

Raise your hand if you could breathe normally. Raise your hand if it was harder to breathe.

So it looks like most of you found breathing more difficult with the straw. This is what it feels like to have a restrictive lung disease, such as asthma or emphysema. The straw simulates the constriction in your airways – there is less room for air to get through when your airways are inflamed.   

Now you may be thinking, “Why does this matter to me?”

Even if you do not have asthma, emphysema, or another lung disease, breathing in polluted air gradually harms your airways, which can lead to lung conditions, or even more harmful conditions. We can’t see it from the outside, but with continued exposure to this polluted air, a lot can happen on

the inside of our body.

Slide 14 – So what’s causing this pollution?

So what do you think is causing this air pollution? Do any volunteers want to share their

ideas [students raise hands, listen to answers]

Those are great answers! Factories are needed to make the iPhones, laptops and TVs that we use every day.

Slide 15 5

Everything we use needs to be produced. But making these items produces a lot of carbon monoxide and lead, which are bad for our health. Also, using a lot of electricity produces sulfur dioxide and nitrogen dioxide, and cars burn fossil fuels that produce carbon monoxide. These harmful gases react together to pollute our air even more.

Slide 16 6

And anything we discard becomes waste, which pollutes the air

with particulate matter and harmful chemicals.

Slide 17

All this can seem a little overwhelming and kind of scary, but thankfully there are definitely ways you can help yourself and those around you! On the screen, you can see that there are many familiar items that we use every day. What do you think we should do for each item to reduce air pollution? [students raise hands, listen to answers ]

Great ideas! You should definitely turn off lights and appliances, like the TV, computer, radio and fan when they are not in use. If possible, carpool, walk, or bike to get around your neighborhood. You could also lower heating and air condition use by setting the thermostat to 78 F during warm months and 68 F during cold months. This will reduce pollution that usually comes from cars.

Slide 18

The three R’s, reduce, reuse, and recycle, can also be used in everyday activities to reduce pollution.

For example, bring your own bags to the grocery store and continue re-using g it every time you go shopping. Plastic bags can be used for trashcans at home, and paper bags can be recycled d by using it for gift-wrapping. This reduces s the amount of plastic and paper bags that we throw away.

Also, recycling isn’t just for cans and bottles – you can also recycle your old clothes and electronics,

so you don’t have to throw them away!

Slide 19

Now we’re going to split into groups of threes - turn to your neighbors, and see if you can come up with 2 more ideas for how you can reduce air pollution. Write them down and be ready to share with us.

Does anyone want to share what they came up with in their small group? [ write up ideas on the board]

Slide 20 YOUR lung function

[show lung function graph from spirometry]

**Please find the associated slides attached as PDF below. BREATHE Intervention Powerpoint.pdf

BREATHE ALTERNATE ACTIVITY SCRIPT

BREATHE Alternate Activity Script Alternate Activity Script

1. **15 min. before Control Group – Introductions, Q&A (15 min.)
2. Introduction (3 min.)
3. Infectivitis* Simulation (20-25 min.)
4. Vaccines (15 minutes)
5. Flu vaccine?
6. Answer questions (3-5 min.)
7. **15 min. after Control Group goes back – Q&A (max 15 min.)

1. Brief introduction! Who you are, what you will be doing today, what will the students be doing today (1 min.)

**Control Group arrives

2 . Slightly more detailed introduction (3 min.)

1.     Introduce who we are, why we’re there

2.     What we will be doing today

3. Infectivitis* Simulation (~20-25 min.):  You will participate in a simulation to

 see how disease spreads in a population without vaccines and with vaccines. The

 simulation uses a fictitious disease calle **Infectivitis*** s*, which makes

 people sick for two days:





1. Activity introduction: Describe that this will be an activity to demonstrate.

2. Read activity script

3.  Explain instruction

4.  Discussion: 

9. What observations can you make about disease transmission from the   stimulation?

                     ii.   Why did some people did some people never get sick in round two?

                     iii.   What might happen if fewer people or more people were vaccinated?

                             

                           

4. Vaccines (15 min.)

      a.     _What is a vaccine?_ ? _**’teacher’ of the immune system**_ *



                                          

       *    A biological agent that improves the body’s immunity to a particular disease. It     stimulates the body to recognize the foreign invader and “remember” it so that the immune system can more easily and rapidly recognize and destroy the disease if it encounters it again.



2.     Types of vaccines (can be turned into skit activity if wanted!)

                                           

        i.     _[Divide students into 3 groups, then hand out info papers. Give students \~1 min. to develop a quick skit showing how the vaccine works]_ ]



                                          

      ii.     Three types of  vaccines: 

Imagine the zombie virus as the antigen of our vaccine:

1. Killed vaccine: Killed vaccine:

**take some zombie virus and kill the disease-causing parts before injecting into bodies. More safe because the vaccine virus will not change, but this vaccine is teaching the body to defend the

none-disease-causing version of the virus which is weaker than the real virus. For example, people need to receive 3 doses to be securely shielded from the virus.**

2. Live, weakened vaccines Live, weakened vaccines

**take live zombie virus, weaken the virus in lab, and inject into uninfected bodies. Because they are live, they behave closest to what the original virus does, the bodies that ‘learned’ to recognize these live weaken viruses would react more effectively when meeting the real zombie virus. But the downsides to this kind of vaccine are the risk of uncontrollable changes happen after injecting into bodies and people with weaker immune system may have the risk of being infected by the vaccine. For example, the zombie virus mutated and changed into a new type of virus after injected into the

body. Or a person who gets sick easily may actually be infected and turn into a zombie when he/she receives the vaccine**

3. Subunit vaccine: Subunit vaccine:

take some zombie virus, study in the lab, and pick the most infectious and disruptive subparts of the virus to be the vaccine. But this vaccine only contains a certain part of the virus, say if we missed the wrong  subparts of the zombie virus, the vaccine will be not strong enough to prevent people from being infected.

                   _4._ . * **toxoid vaccine** e has been removed from this activity for simplicity’s sake, but could be modeled by person leading activity)



                                      

             iii.     Have them explain briefly what their skit means

Use the chart that they figure out where the outbreak starts, choose one or two subjects and say if they had received the Zombie Vaccine, what will be different? Which victims would have saved from being infected?

5 5. Flu vaccine?

6 . Answer any questions they have! (3-5 minutes)

**Control Group leaves

7. . Answer any questions they have/discussion time/wrap up