Appendix III Interview Guide

Appendix III – Interview Guide

In-depth Interviews with Healthcare Professionals and Health Educators on Environmental Contaminants in Food for Young Children

Interview Guide

June 20, 2023

OMB No: 0910-0891 Expiration Date: 09/30/2026

Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0891. The time required to complete this information collection is estimated to average 60 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.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

Study Goals:

• 27 individual in-depth-interviews with stakeholders who are professionally involved in issues of feeding children 6 months to 6 years of age: pediatricians, nurses, WIC specialists, and SNAP and EFNEP educators.

• These interviews will be conducted via Zoom for Government.

• The goals of the study are to explore target audience’s:

  • understanding and knowledge of environmental contaminants in foods consumed by young children, their current practices related to providing information to parents and caregivers about environmental contaminants in foods for young children, and the challenges in providing such information,

  • reactions to Closer to Zero program from FDA, and

  • reactions to FDA’s messages to parents on environmental contaminants in foods.

Introduction [5 min.]

Thank you for agreeing to participate today. I’m _____, and I’m from Westat. We’re a research organization based in Maryland. We are conducting these interviews on behalf of the U.S. Food and Drug Administration (FDA). We will be talking today about issues related to foods for children ages 6 months to 6 years. Your input is very important to us, and your time today is appreciated. This interview will take approximately 60 minutes.

Before we begin, I want to review a few things with you. First, I’ll review with you the main points of the informed consent form that you should have received with the confirmation email to participate in this interview. Please let me know if you have any questions.

• Voluntary Participation. You can stop at any point in the interview. There’s no penalty to you for doing so. In addition, if at any point you feel uncomfortable with my questions, simply let me know that you prefer not to answer.

• Study is for FDA. The findings from these interviews will help FDA better understand how healthcare professionals provide education about feeding children to parents and caregivers of patients from ages 6 months to 6 years. Your insights will help FDA develop educational materials about these issues.

• Findings in a Report for FDA. In the report, we may quote something you say, but we will never include your name, or any identifying information about you. After this interview, no one will contact you about it. Your contact information will be kept secure to the fullest extent of the law.

• Audio and Video Recording. As mentioned on the consent form, we are recording this conversation so that I can give you my full attention and not have to take a lot of notes. Transcripts will be made of the audio recordings to make sure when we do our analyses that we are accurate. FDA will receive a copy of the transcripts, but any identifying information will be removed by myself or other Westat project staff before we send them to FDA.

• Observers/listeners. We would like our colleagues from Westat and consumer studies staff from FDA to view the interview. They may have additional questions for you, so towards the end I’ll check in with them. But please know that all of the project staff who are listening must keep the identity of respondents secure to the extent permitted by law.

Do you have any questions about what I just reviewed? [ANSWER ALL QUESTIONS]

[Ask for permission to record, turn recorder on, get verbal consent to participate and permission to record on the recording.]

Section I. Professional Background [5 min.]

Today, we will be talking about issues related to foods for children 6 months to 6 years of age. The goal is to hear about your current practices related to educating parents and caregivers on their children’s nutrition and the challenges in doing so. This information will assist FDA in developing materials for healthcare professionals and the public to better educate parents and caregivers of children. To start off, tell me…

1. Which part of the country are you calling from?

2. Tell me a little bit about your current professional position.

Probe: What is your title? What type of setting do you work in?

3. What type of patients do you currently see/clients do you have?

4. What proportion of these are parents or caregivers of children 6 months to 6 years of age?

PROBE IF NECESSARY: What proportion of these are parents or caregivers of children 6 to 12 months? 1 to 2 years? Between 3 and 6 years?

For the remainder of this interview, we will focus on foods intended for infants and young children, 6 months to 6 years of age and we will not discuss infant formula or breastfeeding at this time.

Section II. Providing Information Related to Feeding Children and Nutrition and Environmental Contaminants [20 min.]

1. On which occasions, if at all, do you provide advice to parents/caregivers regarding what to feed their children?

2. What are the most common topics you discuss? How do you choose which topics to discuss?

PROBE IF NEEDED: Do parents bring up the topics? Do you have a standardized list of topics you go through? Do you use recommendations from an organization?

ASK IF NEEDED: What kinds of food-related questions do you typically receive from parents or caregivers? How often do you get these types of questions from parents/caregivers?

3. What are the most common recommendations about nutrition and diet that you give to parents or caregivers of infants up to 1 year? 1-to-2-year-old toddlers? Preschool kids up to 6 years old?

INTERVIEWER: Keep this response as short as possible.

4. What resources do you use when providing feeding advice? How satisfied are you with those resources? Why? (e.g., Web, brochures, etc.)

5. Are there any feeding topics that you find hard to discuss? Which ones? Why?

6. Are there feeding topics that you would like to get more information from FDA on? Which ones?

We’re going to shift gears to food safety issues…

7. [If respondent did not mention food safety issues] Do you discuss food safety issues and, if so, which ones?

INTERVIEWER: The respondent may bring up allergies or choking hazards. Please direct them away from these topics if needed.

8. What have you heard about toxic elements or heavy metals in food?

9. What does the term “environmental contaminants” mean to you? Do you feel this is a suitable term to describe heavy metals such as arsenic, lead, cadmium, and mercury?

10. Do you, if at all, discuss environmental contaminants, such as heavy metals in food, with parents and caregivers? If yes, how does this topic generally come up? If no, would you like to?

Probe: Are parents/caregivers asking about contaminants in food? Which ones specifically?

11. Are parents/caregivers asking about heavy metals in foods for babies and young children? PROBE: What about foods given to infants up to 1 year old? What about 1- to 2-year-old toddlers? What about preschool kids up to 6 years old?

12. What, do you think, is the most important message to communicate to parents/caregivers about heavy metals in foods? Why?

13. Do you have any questions about environmental contaminants in foods for infants and young children that you would like more information on? If so, what?

14. If FDA provided materials for you to pass to clients/patients about environmental contaminants, what information would be most helpful? What format would be best to receive this information?

Section III. Reactions to FDA Messages on Toxic Elements in Baby Food and Closer to Zero [25 min.]

FDA is creating educational messages intended for parents, caregivers, healthcare professionals, and health educators to better inform them on steps they can take to reduce the effects of environmental contaminants in baby food. The materials you will be shown are drafts and FDA will use your feedback and feedback from others to improve the educational messages.

[We will show participants draft concepts (see Draft Concept #1, 2, and 3 below) and ask a set of questions after each one. The order of showing these concepts will be rotated in consecutive interviews.] Please focus on the content of each piece and not how it looks.

Draft Concept #1

Environmental contaminants refer to chemicals that may be in foods because they are in the environment where foods are grown, raised, or processed. Contaminants can be taken up by plants and animals from the soil, water, and air and can be harmful to human health.

Contaminants in the soil, water, and air may be present naturally and from current or past pollution. Because certain contaminants come from the earth’s crust, there has always been some level in foods. However, it is only with recent scientific advances that we can now measure different types of environmental contaminants in foods at very low levels and are learning more about exposure from the diet.

1. What is your first impression of what I just read?

2. If you were to explain the main message to parents/caregivers, what would you say?

3. In your opinion, do you think this material would be understandable to parents/caregivers?

4. What aspect of this message is most helpful to you? To your patients/clients?

5. Would you feel comfortable passing this message to your patients/clients? Why?/Why not?

Draft Concept #2

Include foods rich in iron and zinc. 

Iron and zinc are essential nutrients for child development. They also can help prevent the harmful effects of arsenic, lead, cadmium, and mercury.  

• Choose whole grains like whole wheat or barley. They provide B vitamins that help protect against the effects of arsenic. 

• Know your grains. Rice shouldn’t be the only grain. Other grains include wheat, oat, barley, and multigrain. Read the label to see which grains are ingredients. 

• Include meat, poultry, seafood, and/or beans as key sources of iron, zinc, and other nutrients. 

• Seafood has nutrients that support child brain and immune system development. Choices particularly low in mercury include salmon, catfish, shrimp, and pollock (common in fish sticks). 

FDA recognizes that children of varying ages have different feeding needs and messages will include information tailored to infants, children, etc.

6. What is your first impression of what I just read?

7. What aspect of this message is most helpful to you? Your patients/clients?

8. Would you feel comfortable passing this message to your patients/clients? Why/Why not?

9. How would you explain this information to your patients/clients/ parents?

Draft Concept #3

FDA has a program/informational initiative called Closer to Zero which [Interviewer: read aloud this description of the program.]

…is focused on driving down levels of arsenic, lead, cadmium, and mercury (often referred to as heavy metals) in food commonly eaten by babies and young children.  Our priority is protecting the very young because they are more vulnerable to harmful health effects from exposure to these contaminants.  While we, our federal partners, and the food companies work to lower levels in foods, there are things you can do to help ensure your child has good nutrition—this not only supports their health and development but can also help to protect them from the effects of contaminants.

10. What are your first reactions to this program?

11. What, if anything, would you tell parents/caregivers about this program? Why?

Closing Questions

1. What other information would you like to have in these materials?

2. What do you think your patients/clients would like to know?

3. Is there anything else about this topic that you’d like to add?

[Ask follow-up questions from observers]

This concludes the interview. Thank you for your input and your time.

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