Form 4 Att 6 DLW Protocol and Form

Attachment 6

Doubly-Labeled Water Protocol and Form	OMB#: ####-#### EXP.DATE: ##/##/####
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 40 minutes for this questionnaire, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review 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 current, 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 (####-####).

ID LABEL

ENERGY EXPENDITURE TEST

Day of Dosing

Date: |___| |___| / |___| |___| / 20|___| |___|

M M D D Y Y

STOP

Not eligible for EET. Reschedule Visit 1.

In the past week, have you stayed overnight somewhere that is more than 200 miles from your home?

YES 1

NO 2 (GO TO 2)

DON’T KNOW 8

REFUSED 7

STOP

Not eligible for EET. Reschedule Visit 1.

Have you received a blood transfusion or any intravenous fluids in the past week?

YES 1

NO 2 (GO TO 3)

DON’T KNOW 8

REFUSED 7

Ask participant to wait to meet 3-hour fast requirement before continuing or reschedule Visit 1.

Ask participant to wait to meet fluid fast requirement before continuing.

FASTING:

CURRENT TIME: |___| |___| : |___| |___| am pm

At what time did you last eat or

drink anything excluding water? |___| |___| : |___| |___| am pm

DON’T KNOW 8

REFUSED 7

LENGTH OF FAST: (TIME 3.1 - TIME 3.2) |___| |___| : |___| |___|

if < 3 HOURS

In the past hour, did you drink more than 1 cup of water?

YES 1

NO 2 (GO TO 4)

WAIT UNTIL ALL FASTING REQUIREMENTS ARE MET BEFORE CONTINUING
Pre-Dose Urine Specimen #1: Time |___| |___| : |___| |___| am pm
HEIGHT: |___| |___| |___|  |___| cm |___| |___| |___|  |___| cm (HT 1 – HT2) |___| |___| |___|  |___| cm IF HT 1 AND HT 2 DIFFER BY MORE THAN 0.5 CM, TAKE HT3 |___| |___| |___|  |___| cm	WEIGHT: |___| |___| |___|  |___| kg |___| |___| |___|  |___| kg (WT 1 – WT2) |___| |___| |___|  |___| kg IF WT 1 AND WT 2 DIFFER BY MORE THAN 0.3 KG, TAKE WT3 3) |___| |___| |___|  |___| kg
Pre-Dose Urine Specimen #2: Time: |___| |___| : |___| |___| am pm
(KG) A B C D E Male NA < 60 60.1-70 70.1-95 >95.1 Female <55 55.1-75 75.1-110 >110 NA Clean up spillage with preweighed tissue and seal in baggy. Label baggy. DLW Dose: Dose category : A 1 B 2 C 3 D 4 E 5 Bottle number: |___| |___| |___| |___| 7.3. Time of Dose: |___| |___| : |___| |___| am pm . Was there spillage of DLW? YES 1 NO 2
Time of Urine Collection: (collect approximately 2 hours after DLW dose) Specimen #3: |___| |___| : |___| |___| am pm
Collect blood sample. Time of Urine Collection: (collect approximately 3 hours after DLW dose) 9.1. Specimen #4: |___| |___| : |___| |___| am pm 9.2. IS Participant less than 60 years old? YES 1 NO 2
Time of Urine Collection: (collect approximately 4 hours after DLW dose) Specimen #5: |___| |___| : |___| |___| am pm
Time of Urine Collection: (collect approximately 6 hours after DLW dose) Specimen #6: |___| |___| : |___| |___| am pm

Energy Expenditure Test

Urine Collections

Day of Dosing

Heavy Water Dose

Dose Time: _____:_____

 1 hour after the dose

Time: ______:______

Snack: 1 to 3 hours after the dose you may have a breakfast drink, a cereal bar, and up to 12 oz. of coffee, tea, juice, or water. (Please see receptionist)

2 hours after the dose Spot Urine Collection

Time: ______:______

3 hours after the dose Spot Urine Collection

Time: ______:______

• Do not eat or drink anything for the next hour.

• If you are 60 years old or older, we will collect a small blood sample at this time.

4 hours after the dose Spot Urine Collection

Time: ______:______

Thank you very much for your cooperation.

_

ID Label

_ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ ____ __ __ __ __ __ __ __ ____ __ __ __ _

CLINIC SNACK FORM

Intake: (Record time and amount of intake)

Breakfast Drink YES……1 NO……2 Time: |___| |___|:|___| |___| am pm Vol.: ___________ cup

Cereal Bar YES……1 NO……2 Time: |___| |___|:|___| |___| am pm Amt: ¼ ½ ¾ ALL

(.25) (.50) (.75) (1.00)

Other Liquids:

______________________ Time: |___| |___|:|___| |___| am pm Vol.: ___________ cup

______________________ Time: |___| |___|:|___| |___| am pm Vol.: ___________ cup

______________________ Time: |___| |___|:|___| |___| am pm Vol.: ___________ cup

______________________ Time: |___| |___|:|___| |___| am pm Vol.: ___________ cup

______________________ Time: |___| |___|:|___| |___| am pm Vol.: ___________ cup

ID LABEL

ENERGY EXPENDITURE TEST

Post Dose Collection

Date: |___| |___| / |___| |___| / 20|___| |___|

M M D D Y Y

Time of Urine Collection:

Specimen #7: |___| |___| : |___| |___| am pm

DATES TRAVELED:

|__| |__| / |__| |__| / 20|___| |___|

to

|__| |__| / |__| |__| / 20|___| |___|

PLACES VISITED:_______________ __________________________

In the past two weeks, have you stayed overnight

somewhere that is more than 200 miles from your home?

YES 1

NO 2

DON’T KNOW 8

REFUSED 7

Have you received a blood transfusion or any intravenous fluids in the past week?

YES 1

NO 2

DON’T KNOW 8

REFUSED 7

FOR PRE-MENOPAUSAL WOMEN ONLY:

Have you had a menstrual period since your last clinic visit?

YES 1 What date did it start? |__| |__| / |__| |__| /20|__| |__|

NO 2 DON’T KNOW……8

DON’T KNOW 8 REFUSED…………7

REFUSED 7

Time of Urine Collection: (collect approximately 1 hour after specimen #7)

Specimen #8: |___| |___| : |___| |___| am pm