Form 5 Att 7 RMR Protocol

Attachment 7

Resting Metabolic Rate	OMB#: ####-#### EXP.DATE: ##/##/####
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 30 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 (####-####).

Fasting Instructions for Resting Metabolic Rate (RMR)

• Do not eat or drink anything, other than water after midnight the night before your appointment.

• On the morning of your appointment, drink 1 to 2 glasses of water.

• Take your normal medications, except vitamins, minerals, or other nutritional supplements.

• If you are required to take your medication(s) with food, bring your medication(s) with you to the study clinic. We will provide a small snack after your blood has been drawn.

• Do not drink coffee, tea, soda, juice or alcohol.

• Do not eat any food or chew gum.

• Do not take any lozenges, breath mints cough drops, or other cough or cold remedies.

• Do not take any antacids, laxatives, or anti-diarrheals.

• Do not take vitamins, minerals, or other nutritional supplements

• Do not participate in any cardiovascular exercise, resistance training, or heavy physical strain. 

Directions:

Introduce the RMR Questionnaire by reciting the following script:

“IN ORDER TO DETERMINE WHETHER YOU ARE ELIGIBLE FOR THE RMR TODAY, I’M GOING TO ASK YOU SOME QUESTIONS ABOUT FASTING, SMOKING AND EXERCISING. IF YOU’VE MET THE REQUIRED TIMES FOR EACH OF THESE QUESTIONS, I’LL BE ABLE TO MEASURE YOUR RMR OR RESTING METABOLIC RATE.”

Q1: When was the last time you ate or drank anything? Please exclude plain water, coffee, and tea.

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ : ___ ___ AM / PM (circle one)

m m d d y y y y h h m m

Q2. Have you had any of the following since [DATE AND TIME FROM Q1]?

Q2a: Coffee or tea? Yes / No (circle one)

If yes: ___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ : ___ ___ AM / PM (circle one)

m m d d y y y y h h m m

Q2b: Gum, breath mints, lozenges, or cough drops, or other cough or cold remedies? Yes / No (circle one)

If yes: ___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ : ___ ___ AM / PM (circle one)

m m d d y y y y h h m m

Q2c: Antacids, laxatives, or anti-diarrheals? Yes / No (circle one)

If yes: ___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ : ___ ___ AM / PM (circle one)

m m d d y y y y h h m m

Q2d: Dietary supplements such as vitamins and minerals? [Include multivitamins and single nutrient supplements.] Yes / No (circle one)

If yes: ___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ : ___ ___ AM / PM (circle one)

m m d d y y y y h h m m

Q3: Have you smoked any cigarettes or cigars, or chewed tobacco since [DATE AND TIME FROM Q1]? Yes / No (circle one)

If yes: ___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ : ___ ___ AM / PM (circle one)

m m d d y y y y h h m m

Q4: Have you done any cardiovascular exercise and/or resistance training since [DATE AND TIME FROM Q1]? Yes / No (circle one)

If yes: ___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ : ___ ___ AM / PM (circle one)

m m d d y y y y h h m m

Q5: Has your job involved heavy physical strain since [DATE AND TIME FROM Q1]? Yes / No (circle one)

If yes: ___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ : ___ ___ AM / PM (circle one)

m m d d y y y y h h m m

Has participant met fasting requirement? [FASTING REQUIREMENT IS AT LEAST 8 hours for all items listed above, WITH EXCEPTION OF 8 hours for exercise/ resistance training and physical strain, 3 hours FOR black coffee/ tea and 1 hour FOR cigarettes, cigars, or chewed tobacco].

___ Yes

___ No, but will meet fasting requirement within ½ hour

___ No, and will NOT meet fasting requirement within ½ hour

If yes:

Read the following script to participant:

“You have met all of the fasting requirements. We will now be able to obtain your RMR measurement.”

If no, but will meet fasting requirement within 30 minutes before the end of the session:

[SPEAK TO CLINIC MANAGER TO DETERMINE WHETHER PARTICIPANT SHOULD COMPLETE ANOTHER MEASURE BEFORE RETURNING FOR RMR].

If no, and will NOT meet fasting requirement within 30 minutes before the end of the session:

[SPEAK TO CLINIC MANAGER TO DETERMINE WHEN PARTICIPANT SHOULD RETURN TO COMPLETE RMR].