Cognitive Interview

FDA Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats and Declaration of Amount of Added Sugars

Draft Questionnaire

As of April 2013

Form Approved: OMB No. 0910-xxxx

Expiration Date: xx/xx/201x

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.

Study Introduction

Thank you for agreeing to participate. The following questions are about common food products and nutrition 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.

[Time will be recorded by section and/or item once the respondent begins the survey. Please note that the section headings, question numbering, and bracketed comments included in this proposed questionnaire will not be seen by the respondent.]

Section A. Two-Product Comparison Task – Added Sugars Experimental Conditions

Please take a moment to look at the nutrition labels for these two <cereals/yogurts/frozen meals>.

[SHOW A PAIR OF NUTRITION FACTS LABELS]

1. If you wanted to buy the healthier product, which one of these two products would you select?

_______[Food - Left]

_______[Food - Right]

_______I see no difference

_______I don’t know

A1a. [Skip if answer to A1 is “I see no difference” or “I don’t know”] Why did you select that product?

{Open-end response}

2. If you wanted to buy the product that has fewer calories, which one of these two products would you select? [ROTATE A2-A3]

_______[Food - Left]

_______[Food - Right]

_______I see no difference

_______I don’t know

3. If you wanted to buy the product that has less added sugar, which one of these two products would you select?

_______[Food - Left]

_______[Food - Right]

_______I see no difference

_______I don’t know

Section B. Single-Product Task – All Experimental Conditions

[If assigned to added sugars experimental condition: Now, please take a moment to look at this next product. This is a different product from the ones you saw on the previous screen.]

[If assigned to footnote experimental condition: Please take a moment to look at the nutrition label for <this frozen meal/these crackers>.]

[SHOW A SINGLE NUTRITION FACTS LABEL]

The following questions are about <this cereal/yogurt/frozen meal> [OR] <these crackers>.

[Continue to show Nutrition Facts label as participant proceeds through Sections B and C.]

1. Based on what you see on the label, how healthy would you say this product is? Use a scale of 1 to 5, where 1 means “Not at all healthy” and 5 means “Very healthy.”

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

2. If you were trying to maintain a healthy weight, how likely would you be to include this product as part of your diet? [ROTATE B2-B5]

Not at all likely				Very likely	Don’t know
1	2	3	4	5

3. If you were trying to reduce your risk of tooth decay or cavities, how likely would you be to include this product as part of your diet?

Not at all likely				Very likely	Don’t know
1	2	3	4	5

4. If you were trying to reduce your risk of cancer, how likely would you be to include this product as part of your diet?

Not at all likely				Very likely	Don’t know
1	2	3	4	5

5. If you were trying to reduce your risk of osteoporosis or bone problems, how likely would you be to include this product as part of your diet?

Not at all likely				Very likely	Don’t know
1	2	3	4	5

6. If you were trying to limit the amount of added sugars you eat, how likely would you be to eat this product?

Not at all likely				Very likely	Don’t know
1	2	3	4	5

7. On a scale of 1 to 5 where 1 is none or very little and 5 is a lot, how much of each of the following things would you say this product has? [ROTATE ITEMS]

	None or very little 1	2	3	4	A lot 5	Don’t know
Calories
Saturated Fat
Sodium
Sugars
Calcium
Fiber
Iron
Added Sugars

Section C. Comprehension – Footnote Experimental Conditions

[CONTINUE TO SHOW SAME NUTRITION FACTS LABEL AS IN PREVIOUS SECTION]

1. How would you rate this product as a source of Vitamin A?

___Excellent

___Good

___Fair

___Poor

___Don’t know

2. How would you rate this product as a source of Vitamin C?

___Excellent

___Good

___Fair

___Poor

___Don’t know

3. How would you rate this product as a source of Dietary Fiber?

___Excellent

___Good

___Fair

___Poor

___Don’t know

4. Would you agree or disagree with the following statements about this product?

	Agree	Disagree	Neither agree nor disagree	Don’t know
If I included this product as part of my diet, I would have to be careful about how much of it I ate.
This product could be described as “low-fat”
This product could be described as “low in sodium”

Section D. Comprehension – Added Sugars Experimental Conditions

[CONTINUE TO SHOW SAME NUTRITION FACTS LABEL AS IN PREVIOUS SECTION]

1. What is the total amount of sugars in one serving of this product? Please enter the number of grams in the space below. [ROTATE D1-D3]

______ grams

 Don’t know

2. What is the total amount of carbohydrates in one serving of this product? Please enter the number of grams in the space below.

______ grams

 Don’t know

3. What is the total amount of added sugars in one serving of this product? Please enter the number of grams in the space below. [ROTATE D1-D3]

______ grams

 Don’t know

Section E. Label Ratings – All Experimental Conditions (except no-footnote control)

The next questions are about the Nutrition Facts label itself.

When answering these questions, please focus on the part of the label that is inside the blue box shown below.

[Insert one label image based on the respondent’s assigned experimental condition. Participants in footnote experimental conditions will view a label with a blue box around the footnote area. Participants in added sugars experimental conditions will view a label with a blue box around the macronutrients section, including calories.]

	Not at all 1	2	3	4	Very 5	Don’t know
How hard is it to understand the information shown in the blue box?
How useful is the information in the blue box to you personally?
How believable is the information in the blue box?

[CONTINUE TO DISPLAY IMAGE]

4. Thinking about the information shown in the blue box, how helpful is this information for doing the following things?

	Not at all helpful 1	2	3	4	Very helpful 5	Don’t know
For comparing products?
For planning a healthy diet?
For determining the healthfulness of the food?
For deciding how much of this food you should eat?
[Skip if footnote condition has been assigned] For determining the amount of added sugar in the food?

Section F. Consumption/Purchase of Foods and Typical Food Label Use – All Experimental Conditions

The next questions are general questions. These questions are not about the labels you saw in the previous questions. [Show F1 on a new screen after this instruction is shown.]

1. During the past 30 days, about how often did you eat these types of foods? Please select one answer for each food.

	Not at all	Less than once a week	1-2 times per week	3-4 times per week	5 or more times per week	Don’t know
Yogurt
Cereal
Frozen meals
Crackers

2. During the past 30 days, about how often did you yourself BUY these types of foods?

	Not at all	Less than once a week	Once a week	More than once a week	Don’t know
Yogurt
Cereal
Frozen meals
Crackers

3. When you buy a food product for the first time, how often do you read the Nutrition Facts label?

___ Often

___ Sometimes

___ Rarely

___ Never

___ Don’t know

4. In the last two weeks, has there been any instance where you changed your decision to buy or eat a food product because you read the Nutrition Facts label?

___Yes

___No

___Don’t know

5. How much do you agree or disagree with each of the following statements? Please select one answer for each statement.

	Strongly Agree	Somewhat Agree	Neither Agree nor Disagree	Somewhat Disagree	Strongly Disagree	No opinion
I am confident that I know how to choose healthy foods.
The information on the food label is hard for me to understand.
It takes too much time to read the food label.
I’m not that interested in the nutrition information on the food label.
When I use food labels, I make better food choices.
The nutrition information on food labels is useful to me.

6. The list below includes the ingredients that might be found in a dessert product. Which of these ingredients would you consider to be added sugars? You may mark one or more ingredients. [ROTATE ORDER EXCEPT LAST THREE.]

___ Enriched Flour

___ Vegetable Oil

___ Brown Sugar

___ Corn Syrup

___ Dextrose

___ High Fructose Corn Syrup

___ Salt

___ Honey

___ Molasses

___ Cinnamon

___ Baking Soda

___ Fruit Juice Concentrate

___ All of the above

___ None of the above

___ Don’t know

Section G. Dietary Awareness and Interests – All Experimental Conditions

We have one final set of questions about you and your health, since this is a survey about nutrition and health.

1. Do you consider yourself to be overweight, underweight, or about the right weight?

____Overweight

____Underweight

____About the right weight

____Prefer not to answer

2. Have you ever been told by a doctor or other healthcare professional that you have any of the following health conditions -- high blood pressure, diabetes, high cholesterol, heart disease, obesity, overweight, osteoporosis or cancer? We don’t need to know which condition, just whether you have ANY of them.

____Yes

____No

____Prefer not to answer

3. How concerned are you, if at all, with the types of fat you consume in the foods you eat? [ROTATE G3-G4]

Not at all concerned				Very concerned	Don’t know
1	2	3	4	5

4. How concerned are you, if at all, with the types of sugar you consume in the foods you eat?

Not at all concerned				Very concerned	Don’t know
1	2	3	4	5

5. During the past 3 months, have you been trying to limit or cut down on these things in your diet?

	Yes	No	Prefer not to answer
Fat
Carbs or carbohydrates
Sodium or salt
Calories
Cholesterol
Sugar
Processed food

6. About how many calories do you think a person of your age, gender, and physical activity needs to consume in a day to maintain your weight?

___Less than 500 calories

___500-1000 calories

___1001-1500 calories

___1501-2000 calories

___2001-2500 calories

___2501-3000 calories

___More than 3000 calories

___Don’t know

7. In a typical week during the past 30 days, about how many days per week did you do moderate or vigorous physical activities such as brisk walking, jogging, biking, aerobics, or yard work for at least 30 minutes?

Please enter a number ranging from 0 to 7: ____ Days per week

____ Prefer not to answer

Section H. Health Status and Demographics – All Experimental Conditions

1. In what year were you born?

__________

____Prefer not to answer

2. Are you male or female?

____Male

____Female

____Prefer not to answer

3. How tall are you without your shoes on? Please enter your height in the spaces below.

Feet _____ Inches ____ ____Prefer not to answer

4. How much do you weigh without your shoes on? Please enter your weight in the space below.

Pounds ______ ____Prefer not to answer

5. What is the highest degree or level of school you have COMPLETED? Please select one.

_____Less than 9^th grade

_____9^th grade to 12^th 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

6. Are you of Hispanic or Latino origin? Please select one.

_____Yes

_____No

_____Prefer not to answer

7. What race do you consider yourself to be? Please select one or more.

_____American Indian or Alaska Native

_____Asian

_____Black or African American

_____Native Hawaiian or other Pacific Islander

_____White

_____Other

_____Prefer not to answer

FOR PRETESTS ONLY

P1. If you have any comments about this survey, please provide them in the space below.

[PROVIDE SPACE FOR OPEN-END RESPONSE]

_____ I have no comments

P2. Is there anything specific that you would suggest changing about this survey?

[PROVIDE SPACE FOR OPEN-END RESPONSE]

_____ I have no suggestions

You have reached the end of the survey. Thank you very much for your participation in this research.

Information about how to understand and use the Nutrition Facts label is available at http://www.fda.gov/Food/ResourcesForYou/Consumers/NFLPM/default.htm