Cognitive Interview

Appendix B

Experimental Study on Consumer Responses to

Labeling Statements on Food Packages

Draft Questionnaire

Form Approved: OMB No. 0910-xxxx

Expiration Date: xx/xx/201x

Your information will be kept private to the extent permitted by law.

(Contractor) assures the privacy of your information following its privacy policy.

PUBLIC Disclosure Burden Statement

Public reporting burden for this collection of information is estimated to average 15 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:

Department of Health and Human Services
Food and Drug Administration
CFSAN/PRA Comments/HFS-24
5100 Paint Branch Parkway
College Park, MD 20740-3835.

[DISABLE “PREVOUS” OR “BACK” FUNCTIONALITY]

Study Introduction:

Thank you for agreeing to participate. The following questions are about common food products and the labels you might see on these products. It usually takes about 15 minutes to answer all the questions. The information you provide will be kept strictly confidential.

Please click the “NEXT” button to begin the study.

Section A. Food consumption and purchase

[FOOD 1 AND FOOD 2 ARE THE FOODS RANDOMLY ASSIGNED TO THE RESPONDENT; FOOD 3 IS THE THIRD FOOD IN THE STUDY.]

A1. [ALL PARTICIPANTS] First of all, during the past 30 days, about how often did you eat these types of foods? Please select one answer for each food. [ROTATE FOODS]

	5 or more times per week	3-4 times per week	1-2 times per week	Less than once a week	Not at all	Don’t know
Food 1
Food 2
Food 3

A2. [ALL PARTICIPANTS] In the past six months, did you yourself shop for all, most, some, or none of these foods you ate? Please select one. [USE SAME ORDER OF FOODS AS IN A1]

	All	Most	Some	None	Don’t eat	Don’t know
Food 1
Food 2
Food 3

Section B. Label Responses

[SHOW LABEL 1]

The next few questions are about the product you see on the screen.

Note that the label information you see in this study may or may not be the same as you would see at the grocery store.

You will be able to see the product while answering each question. At any point during a question, you may click on the "TURN" button to see the Nutrition Facts of the product for more information. [Skip last sentence if NF-only condition.]

FOOD 1

B0. Please take a moment to look at this product.

When you are ready to continue the survey, click on the "NEXT" button.

B1. [SHOW LABEL 1] On a scale of 1 to 6, where 1 is “not healthy at all” and 6 is “very healthy,” how healthy would you say this product is?

1 = not healthy at all

2

3

4

5

6 = very healthy

Don’t know

[Record any click to see the NF panel during B1]

B2. [SHOW LABEL 1] On a scale of 1 to 6, where 1 is “very unlikely” and 6 is “very likely,” how likely is it that this product would help reduce the risk of the following health problems? Please select one rating for each health problem.

	Very unlikely 1	2	3	4	5	Very likely 6	Don’t know
Hypertension or high blood pressure
Cancer
Osteoporosis or bone problem
Diabetes or high blood sugar
Heart disease
Obesity or overweight
Digestive problems

[Record any click to see the NF panel during B2]

B3. [SHOW LABEL 1] On a scale of 1 to 6, where 1 is “none or a little” and 6 is “a lot,” how much of each of the following things would you say this product has? [ROTATE ITEMS]

	None or a little 1	2	3	4	5	A lot 6	Don’t know
Calories
Total Fat
Sodium
Sugars
Vitamins and minerals
Fiber

[Record any click to see the NF panel during B3. Reset after B3 is answered so that the NF panel is no longer available.]

B4. [SHOW LABEL 1] On a scale of 1 to 6, where 1 is “not tasty at all” and 6 is “very tasty,” how tasty would you expect this product to be?

1 = not tasty at all

2

3

4

5

6 = very tasty

Don’t know

B5. [SHOW LABEL 1] Imagine that you are in a grocery store and thinking about getting some [FOOD] for yourself. Assume the [FOOD] you see here is comparable to other [FOOD]s on the shelf in terms of price, taste, flavor, and nutritional quality.

On a six-point scale, where 1 means “definitely would not consider buying” and 6 means “definitely would consider buying,” how likely would you be to consider buying THIS [FOOD] rather than another [FOOD]?

1= Definitely would not consider buying

2

3

4

5

6= Definitely would consider buying

Don’t know

FOOD 2

B6. Please take a moment to look at this next product. This is a different product from the one you saw previously.

When you are ready to continue the survey, click on the "NEXT" button.

B7-B11 [REPEAT B1-B5 FOR THE SECOND FOOD]

[Start the following instructions on a new screen.]

Now that you have had a chance to rate some products, we have a few questions about the package labels that you just saw.

Here is the first label you saw. [Display Label 1 without the NF panel, unless NF-only control.]

B12. [SHOW LABEL 1] On a scale of 1 to 6, where 1 is “not helpful at all” and 6 is “very helpful,” how helpful is the label in telling you the nutritional qualities of this product?

1 = not helpful at all

2

3

4

5

6 = very helpful

Don’t know

B13. [SHOW LABEL 1] On a scale of 1 to 6, where 1 is “not trustworthy at all” and 6 is “very trustworthy,” how trustworthy is the label in telling you the possible health benefits of this product?

1 = not trustworthy at all

2

3

4

5

6 = very trustworthy

Don’t know

B14. [SHOW LABEL 1] On a scale of 1 to 6, where 1 is “not helpful at all” and 6 is “very helpful,” how much does the label help you decide whether to buy this product?

1 = not helpful at all

2

3

4

5

6 = very helpful

Don’t know

Here is the second label you saw. [Display Label 2 without the NF panel, unless NF-only control.]

B15-17 [Repeat questions B12-B14.]

Section C. Food purchase and knowledge, and label reading

The next section of the survey includes general questions. These questions are not about the labels you saw in the previous questions. [Start next question on a new screen.]

[ASK C1-C3 IF A2 = ALL/MOST/SOME FOR FOOD 1]

C1. Think about shopping for [FOOD 1] at the store. On a scale of 1 to 6, where 1 is “not important at all” and 6 is “very important”, how important to you is each of the factors listed below? [ROTATE FACTORS]

	Not important at all 1	2	3	4	5	Very important 6	Don’t know
Price
Brand
Healthiness or nutritional qualities
Convenience
Taste

C2. At the store, how often do you read labels on [FOOD 1, plural] to compare how healthy or nutritious different [FOOD 1, plural] are?

Always

Most of the time

Sometimes

Rarely

Never

Don’t know

C3. When you buy a type of [FOOD 1] for the first time, how often do you read the label to find out how much it has of things like calories, fat, sodium, or vitamins?

Always

Most of the time

Sometimes

Rarely

Never

Don’t know

C4. [ALL PARTICIPANTS]

Compared to the average consumer, how knowledgeable are you about the average nutritional qualities of [FOOD 1]?
1 One of the least knowledgeable	2	3	4	5	6 One of the most knowledgeable	Don’t know
How familiar are you with the average nutritional qualities of [FOOD 1]?
1 Not at all familiar	2	3	4	5	6 Extremely familiar	Don’t know

C5-C8 [REPEAT C1-C3 FOR FOOD 2 IF A2 = ALL/MOST/SOME FOR FOOD 2. REPEAT C4 FOR FOOD 2 FOR ALL PARTICIPANTS.]

Section D. Food perception

D1. [ALL PARTICIPANTS] How healthy would you say each of these types of foods is in general, on a scale of 1 to 6?

	Not healthy at all 1	2	3	4	5	Very healthy 6	Don’t know
Food 1
Food 2
Food 3

D2. [ALL PARTICIPANTS] Have you ever heard or read that [FOOD 1] may help lower the risk of the following health problems? [ROTATE HEALTH PROBLEMS]

	Yes	No	Don’t know
Hypertension or high blood pressure
Cancer
Diabetes or high blood sugar
Heart disease
Obesity or overweight
Digest problems
Osteoporosis or bone problem

D3. [ALL PARTICIPANTS] Have you ever heard or read that [FOOD 2] may help lower the risk of the following health problems? [ROTATE HEALTH PROBLEMS]

	Yes	No	Don’t know
Hypertension or high blood pressure
Cancer
Diabetes or high blood sugar
Heart disease
Obesity or overweight
Digest problems
Osteoporosis or bone problem

Section E. Dietary Interests and Restrictions

E1. [ALL PARTICIPANTS] From the list below, which have you tried to limit in the past 30 days? Select all that apply. [ROTATE ITEMS, EXCEPT “NONE OF THE ABOVE, DON’T KNOW, AND PREFER NOT TO ANSWER”]

	Yes
Fat
Carbs or carbohydrate
Salt or sodium
Calories
Cholesterol
Sugar
None of the above
Don’t know
Prefer not to answer

E2. [ALL PARTICIPANTS] From the list below, which have you ever tried to have enough of in the past 30 days? Select all that apply. [ROTATE ITEMS, EXCEPT “NONE OF THE ABOVE, DON’T KNOW, AND PREFER NOT TO ANSWER”]

	Yes
Omega-3 fatty acid
Vitamin D
Calcium
Iron
Fiber
None of the above
Don’t know
Prefer not to answer

E3. [ALL PARTICIPANTS] Do you consider yourself to be a vegetarian?

Yes

No

Don’t know

Prefer not to answer

E4. [ALL PARTICIPANTS] Do you have any food allergies?

Yes

No

Don’t know

Prefer not to answer

E5. [ALL PARTICIPANTS] On a scale of 1 to 6, where 1 is “not interested at all” and 6 is “very interested,” how interested are you in buying products that say they are labeled as Natural or Organic?

1 = not interested at all

2

3

4

5

6 = very interested

Don’t know

Section F. Motivation regarding label use and health literacy

F1. [ALL PARTICIPANTS] How much do you agree with each of the following statements? Please select one answer for each statement.

	Strongly disagree	Somewhat disagree	Somewhat agree	Strongly agree	Don’t know
I feel confident that I know how to use food labels to choose a nutritious diet.
The nutrition information on food labels is hard to understand.
Reading food labels takes more time than I can spare.
The nutrition information on food labels is useful to me.
Reading food labels makes it easier to choose foods.
When I use food labels, I make better food choices.
Using food labels to choose foods is better than just relying on my own knowledge about what is in them.

The next six questions are about the label shown on the screen. Please look at this label as long as you like.

Imagine that this information is on the back of a container of a pint of ice cream.

F2. If you eat the entire container, how many calories will you eat? __________ calories

F3. If you are allowed to eat 60 g of carbohydrates as a snack, how much of this product could you have? __________ grams

F4. Suppose your doctor advises you to reduce the amount of saturated fat in your diet. You usually have 42 g of saturated fat each day, which includes 1 serving of this product. If you stop eating this product, how many grams of saturated fat would you be consuming each day? __________

F5. If you usually eat 2,500 calories in a day, what percentage of your daily value of calories will you be eating if you eat one serving of this product? __________ percent

F6. Pretend that you are allergic to the following substances: penicillin, peanuts, latex gloves, and bee stings. Is it safe for you to eat this product?

Yes

No

DK

F7. [IF F6 = NO] Why is it not safe for you to eat this product? __________

Section G. Health status and demographics

We have one final set of questions about you and your health. It is not required that you answer these questions. We use this information for analysis purposes and to better understand the information obtained in this study as a whole. All answers to this survey will be kept private.

G1. [ALL PARTICIPANTS] Would you say your health in general is …

excellent

very good

good

fair

poor

Don’t know

Prefer not to answer

G2. [ALL PARTICIPANTS] Have you been told by a doctor or other healthcare professional that you have any of these health problems? Check all that apply. [RAMDOM ORDER]

	Yes	No	Don’t know	Prefer not to answer
Cancer
Diabetes
Heart disease
Hypertension or high blood pressure
High cholesterol
Obesity or overweight
Osteoporosis or bone problem
Stroke

G3. [ALL PARTICIPANTS] Are these health problems of concern to you? Please select an answer for each of the health problems. [ROTATE HEALTH PROBLEMS]

	Yes	No	Don’t know	Prefer not to answer
Cancer
Diabetes
Heart disease
Hypertension or high blood pressure
High cholesterol
Obesity or overweight
Osteoporosis or bone problem
Stroke

G4. [ALL PARTICIPANTS] How tall are you without your shoes on? Please enter your height in the spaces below.

Feet _ [ONE SPACE] Inches _ _ [TWO SPACES]

Prefer not to answer

G5. [ALL PARTICIPANTS] How much do you weigh without your shoes on? Please enter your weight in the space below.

Pounds _ _ _ [THREE SPACES]

Prefer not to answer

G6. [ALL PARTICIPANTS] Do you consider yourself to be overweight, underweight, or about the right weight?

Overweight

Underweight

About the right weight

Prefer not to answer

G7. [ALL PARTICIPANTS] What is the highest grade or level of school you have completed or the highest degree you have received? Please select one.

Less than 9th grade	Yes
9th grade to 12th grade, No Diploma
High school graduate - Diploma or GED
Some college or Associate degree
Bachelor’s degree
Graduate or professional degree

Prefer not to answer

G8. [ALL PARTICIPANTS] What year were you born?

19 _ _ [TWO SPACES]

Prefer not to answer

G9. [ALL PARTICIPANTS] Are you female or male?

Female

Male

Prefer not to answer

G10. [ALL PARTICIPANTS] Are you of Hispanic or Latino origin? Please select one.

Yes

No

Prefer not to answer

G11. [ALL PARTICIPANTS] What race do you consider yourself to be? Please select one or more.

	Yes
American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or other Pacific Islander
White
Other

Prefer not to answer

Thank you. These are all the questions in this survey. We hope you have enjoyed your participation in the survey.

END

13