1 Survey

Appendix A A.2.3.j–1

OMB #: 0925-xxxx

Expiration Date: xx/xxxx

National Children’s Study

Adult Saliva Collection Instructions

This kit contains everything you will need to provide a sample of your saliva:

6 straws

6 small containers

1 zip lock plastic bag with absorbent pad

We are asking you to collect saliva samples for two days in a row. You should collect your first saliva sample as soon as you wake up (Wake sample); collect the second sample 30 minutes after the first (+30 sample); and collect the third saliva sample at night before you go to bed, at least 1 hour after eating but before brushing your teeth (Bedtime sample).

Day 1 Use the three small containers labeled with a Green label marked with a ☼, +30, and .

Use the small container marked with a ☼ to collect the Wake sample.

Use the small container marked with a +30 to collect the +30 sample.

Use the small container marked with a to collect the Bedtime sample.

Day 2 Use the three small containers labeled with a Orange label marked with a ☼ +30, and .

Use the small container marked with a ☼ to collect the Wake sample.

Use the small container marked with a +30 to collect the +30 sample.

Use the small container marked with a to collect the Bedtime sample.

IMPORTANT NOTES

• Please record the time that you collect each sample.

• Take the first sample as soon as you wake up! It is okay to either wake up naturally or to an alarm clock, but you should not lie in bed and doze before you begin.

• Do not eat, drink, smoke or brush your teeth before collecting both morning samples (Wake and +30)

• Do not eat, drink, smoke or brush your teeth for 1 hour before collecting the Bedtime sample. If this cannot be avoided, rinse your mouth thoroughly with water at least 5 minutes before collecting the sample.

• Do not drink alcohol for 12 hours prior to collecting the samples.

• If your mouth is dry, do not use salivary stimulants such as chewing gum, lemon drops, sugar, or drink crystals such as Kool-Aid or Crystal Light prior to collecting the samples.

• Avoid heavy exercise on the days that you are collecting these samples.

• Do not collect samples within 24 hours after having dental work.

Instructions for collection:

Day 1

1. To collect your first sample use the small container with a green label marked with a ☼. Remove the cap.

2. Remove a single straw from the plastic bag. Place one end of the straw into the small container.

3. Place your mouth on the other end of the straw. Imagine eating your favorite food and allow saliva to pool in your mouth. (It is okay to gently chew on the end of the straw.)

4. Tilt your head forward and drool down the straw to collect your saliva in the small container. Do not spit or blow through the straw as this will cause excess foam. The small container should be half full of liquid not including any foam that may have formed.

5. Tightly screw the cap on the small container place the small container in the zip lock bag that contains an absorbent pad, seal the bag, and place the bag in the freezer.

6. Complete the Day 1: Adult 2-Day Saliva Data Collection Form including the time the sample was collected.

7. 30 minutes after you collect the “Day 1 Wake” sample, repeat steps 2-6 for the “Day 1 +30” sample. Remember not to eat, drink, smoke or brush your teeth before you collect the “Day 1 +30” sample. Record the time the sample was collected on the Day 1: Adult 2-Day Saliva Data Collection Form.

8. Before you go to bed, collect the “Day 1 Bedtime” sample as described in steps 2-6. Remember you should collect this sample before you brush your teeth and at least 1 hour after eating. Complete the Day 1: Adult 2-Day Saliva Data Collection Form.

Day 2

Repeat steps above using the small container with the orange labels for the Day 2 Wake, Day 2 +30 and the Day 2 Bedtime samples and complete the Day 2: Adult 2-Day Saliva Data Collection Form.

Please keep the zip lock bag containing the saliva samples in the freezer until the samples can be picked up by Study staff.

National Children’s Study

DAY 1: ADULT 2-DAY SALIVA DATA COLLECTION FORM

Please collect your saliva samples on the 2 days following our visit to your home on __________. Please write down the exact time that you collected each saliva sample in the spaces below.

Day 1 Saliva Samples

What is the date you collected the Day 1 saliva samples? ____/___ /____

Month Day Year

Tube	When to take sample	Time collected
Wake ☼	As soon as you wake up	_____:_____ a. __ am b. __ pm (Check am or pm) (Answer questions 1 & 2)

Please answer the following question after you have collected the Wake ☼ saliva sample:

1. Did you spend any time dozing in bed before you collected

the first saliva sample (Wake ☼ saliva sample) this morning? Yes No

2. If yes, estimate of time spent dozing before collecting

the Wake ☼ saliva sample .________________ minutes

Tube	When to take sample	Time collected
+30	30 minutes after waking up	_____:_____ a. __ am b. __ pm (Check am or pm)

Tube	When to take sample	Time collected
Bedtime .	Before brushing your teeth and at least 1 hour after eating for the last time today	_____:_____ a. __ am b. __ pm (Check am or pm) (Answer questions 3, 4, & 5)

Please turn to back of page.

Please answer the following questions about your activities prior to collecting the Bedtime saliva sample:

3. During the 2 hours prior to collecting the Bedtime saliva sample have you done any of the following:

Consumed a caffeinated beverage (coffee, tea, soda)? Yes No

Smoked? Yes No

Consumed alcohol? Yes No

4. During the 2 hours prior to collecting the Bedtime saliva sample what has your level of physical activity been?

None

Light (standing, light walking, light house work)

Moderate (yard work, brisk walking)

Intense (jogging, exercise classes)

5. Please write down the name of any prescription or over the counter medications that you have taken today. Please be specific. For example, if you took Robitussin DM®, write Robitussin DM®, not Robitussin ®.

None

_________________________ ______________________

_________________________ ______________________

_________________________ ______________________

Please feel free to call if you have any questions: X at phone #

For Data Collector’s Use Only

Were the saliva samples frozen when received from the participant? Yes No

National Children’s Study

DAY 2: ADULT 2-DAY SALIVA DATA COLLECTION FORM

Please collect your saliva samples on the 2 days following our visit to your home on __________. Please write down the exact time that you collected each saliva sample in the spaces below.

Day 2 Saliva Samples

What is the date you collected the Day 1 saliva samples? ____/___ /____

Month Day Year

Tube	When to take sample	Time collected
Wake ☼	As soon as you wake up	_____:_____ a. __ am b. __ pm (Check am or pm) (Answer questions 1 & 2)

Please answer the following question after you have collected the Wake ☼ saliva sample:

3. Did you spend any time dozing in bed before you collected

the first saliva sample (Wake ☼ saliva sample) this morning? Yes No

4. If yes, estimate of time spent dozing before collecting

the Wake ☼ saliva sample .________________ minutes

Tube	When to take sample	Time collected
+30	30 minutes after waking up	_____:_____ a. __ am b. __ pm (Check am or pm)

Tube	When to take sample	Time collected
Bedtime .	Before brushing your teeth and at least 1 hour after eating for the last time today	_____:_____ a. __ am b. __ pm (Check am or pm) (Answer questions 3, 4, & 5)

Please turn to back of page.

Please answer the following questions about your activities prior to collecting the Bedtime saliva sample:

3. During the 2 hours prior to collecting the Bedtime saliva sample have you done any of the following:

Consumed a caffeinated beverage (coffee, tea, soda)? Yes No

Smoked? Yes No

Consumed alcohol? Yes No

4. During the 2 hours prior to collecting the Bedtime saliva sample what has your level physical activity been?

None

Light (standing, light walking, light house work)

Moderate (yard work, brisk walking)

Intense (jogging, exercise classes)

5. Please write down the name of any prescription or over the counter medications that you have taken today. Please be specific. For example, if you took Robitussin DM®, write Robitussin DM®, not Robitussin ®.

None

_________________________ ______________________

_________________________ ______________________

_________________________ ______________________

Please feel free to call if you have any questions: X at phone #

For Data Collector’s Use Only

Were the saliva samples frozen when received from the participant? Yes No

Revised 7/8/08

Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this address.