Focus Groups on Childhood Obesity with Hispanic Primary Caregivers (CFSAN)

Appendix I

OMB No: 0910-0497 Expiration Date: 10/31/2020

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 0910-0497. The time required to complete this screening document is estimated to average 5 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.

Focus Groups with English- and Spanish-Speaking Hispanic
Low-Income Parents on Childhood Obesity
Appendix I: Screener

The target audience for these focus groups is low-income U.S. adult (18+) consumers who are parents/caregivers to children (3 to 6 yrs.).

Recruiting Goals

• Twelve (12) focus groups will be conducted, and segmented as follows:

Group	Access and Facility Type	Race/Ethnicity/Language
Mock*	TBD	TBD
Group 1	High Access; Conventional Facility	English-Speaking Hispanics
Group 2	High Access; Conventional Facility	English-Speaking Hispanics
Group 3	High Access; Conventional Facility	Spanish-Speaking Hispanics
Group 4	High Access; Conventional Facility	Spanish-Speaking Hispanics
Group 5	High Access; Conventional Facility	English-Speaking, Non-Hispanic White
Group 6	High Access; Conventional Facility	English-Speaking, Non-Hispanic White
Group 7	Low Access; Non-Conventional Facility	English-Speaking Hispanics
Group 8	Low Access; Non-Conventional Facility	English-Speaking Hispanics
Group 9	Low Access; Non-Conventional Facility	Spanish-Speaking Hispanics
Group 10	Low Access; Non-Conventional Facility	Spanish-Speaking Hispanics
Group 11	Low Access; Non-Conventional Facility	English-Speaking, Non-Hispanic White
Group 12	Low Access; Non-Conventional Facility	English-Speaking, Non-Hispanic White

*Data collected from mock focus group will not be included in analysis

• The groups will include adults of ages 18 to 60.

• Each participant must have at least one child between the ages of 3 to 6 years living with them in the same household.

• The groups will be conducted with low-income adults (e.g., adults living in households with a size-adjusted income that is 200%FPL¹).

• The groups will consist of participants who mostly prepare their family’s food at home.

• All participants must be able to understand and speak the language of the group: English for English-speaking groups and Spanish for Spanish-speaking groups.

• Participants cannot have participated in a focus group or a similar study in the past six months. Participation in phone surveys is allowed.

• In Austin, participants cannot have participated in earlier Phase 1 focus groups.

• Sufficient recruits will be invited in order to achieve a target of 8-10 participants per group.

• Each participant will receive a $75 token of appreciation for participating in the focus group.

Study Protocol

• Each group will last approximately 90 minutes (excluding time needed for signing in before the group starts and signing out after the group ends).

• Groups will be audio- and video-taped and also video-streamed via a password-protected website. Participant written consent will be obtained before the group discussion starts.

• The identity of the participants will be kept secure in accordance with the Privacy Act and to the extent provided by law.

• Any information provided by participants will be kept secure to the extent permitted to law. An exception will be made when there is a direct threat of harm to the participant or others.

• Groups will be observed by a research team including staff from FDA

• Participants do not have to answer any questions that they do not want to, but are encouraged to participate.

Appendix I

OMB No: 0910-0497 Expiration Date: 10/31/2020

Participant Screener Script

Hello Ms./Mr. __________________________________, my name is __________________ and I'm calling about a research study sponsored by the U.S. Food and Drug Administration in your area. We are looking for adults, who are the primary caregivers of children 3-6 years old, to take part in upcoming focus group discussions about eating and health.

If you’re interested in participating, would you mind answering a few questions?

• Yes

• No  eliminate [thank respondent politely]

DETERMINE GENDER

• Male  recruit no more than 4 males per group; with aim of <2 sitting in group

• Female

Q1. Do you or someone from your immediate family work for any of the following:

• A Market Research Firm  eliminate [thank respondent politely]

• Nutritionist or Dietician  eliminate [thank respondent politely]

• Food Industry, Restaurant or Food Retailer  eliminate [thank respondent politely]

• A Public Health Organization  eliminate [thank respondent politely]

• State or local food agency,

• U.S. Department of Agriculture, or

• U.S. Food and Drug Administration  eliminate [thank respondent politely]

Q2. Have you participated in a focus group within the past 6 months?
[Interviewer: participation in telephone surveys is allowed. If explanation is needed: A focus group is a when a small group of individuals come together to talk about a certain topic. For Austin groups, any participant in the previous round of these focus groups must be excluded.]

• Yes  eliminate [thank respondent politely]

• No

Q3. Do you have a child/children living with you in your household?

• Yes

• No  eliminate [thank respondent politely]

Q3a. What is/are the age(s) of your child/children?

[ELIMINATE if there are no children between 3-6 years old.]

Q4. In an average week, about how many days, if any, do you and your children eat food prepared by a restaurant or convenience store?

• 0-1

• 2-4

• 5-7  eliminate [thank respondent politely]

Q5. Are you the person who prepares at least half of the meals eaten at your home for your family?

• Yes

• No, never or almost never  eliminate [thank respondent politely]

Q6. Are you the person who usually goes grocery shopping for your family?

• Yes

• No, never or almost never  eliminate [thank respondent politely]

Q7. What is the highest level of education that you have completed?

• Less than high school

• High school graduate or GED

• Technical/vocational school

• Community college

• Some college (1-3 years towards Bachelor’s degree)

• College (Bachelor’s degree)

• Advanced degree (postgraduate degree)  no quota, but no more than 2 in one group

Q8. Are you of Hispanic or Latino origin?

• Yes  recruit to Hispanic Groups; go to Q9

• No  continue

• Prefer not to answer  eliminate [thank respondent kindly]

Q8a. What is your race? I am going to read several categories of race. You may choose one or more categories. Are you…?

• White  recruit to White Groups

• Black or African American  eliminate [thank respondent kindly]

• Asian  eliminate [thank respondent kindly]

• Native Hawaiian or other Pacific Islander  eliminate [thank respondent kindly]

• American Indian or Alaska Native  eliminate [thank respondent kindly]

• Prefer not to answer  eliminate [thank respondent kindly]

IF SCREENER IS CONDUCTED IN ENGLISH, GO TO Q10 AND RECRUIT TO ENGLISH-SPEAKING GROUP.

Q9. What language do you mostly speak at home?

• English  Recruit to English-Speaking group; GO TO Q10

• Spanish  Recruit to Spanish-Speaking group

Q9a. Do you speak English?

• YES

• NO  GO TO Q10

Q9b. Would you feel comfortable participating in a group discussion in English?

• Yes  Recruit to English-Speaking group IF NEEDED

• No  Recruit to Spanish-Speaking group

Q10. I am going to read some age categories, could you please tell me in which category your age falls?

• Under 18 years old  eliminate [thank respondent politely]

• 18-30

• 31-40

• 41-50

• 51-60

• 61 and over

Q11. How many people, including yourself, live in your household? ______________

IF HOUSEHOLD SIZE = 1  eliminate [thank respondent politely]

Q12. INCOME²

IF HH SIZE IS…	THEN ASK…	RECORD RESPONSE
2	Is your annual household income more than $33,800 less than $33,800, or just about $33,800?	More than  ELIMINATE Less than Just about  ELIMINATE (PUT ON RESERVE LIST IN CASE NEEDED)
3	Is your annual household income more than $42,700, less than $42,700, or just about $42,700?	More than  ELIMINATE Less than Just about  ELIMINATE (PUT ON RESERVE LIST IN CASE NEEDED)
4	Is your annual household income more than $51,500, less than $51,500, or just about $51,500?	More than  ELIMINATE Less than Just about  ELIMINATE (PUT ON RESERVE LIST IN CASE NEEDED)
5	Is your annual household income more than $60,300, less than $60,300, or just about $60,300?	More than  ELIMINATE Less than Just about  ELIMINATE (PUT ON RESERVE LIST IN CASE NEEDED)
6	Is your annual household income more than $69,200, less than $69,200, or just about $69,200?	More than  ELIMINATE Less than Just about  ELIMINATE (PUT ON RESERVE LIST IN CASE NEEDED)
7	Is your annual household income more than $78,000, less than$78,000, or just about $78,000?	More than  ELIMINATE Less than Just about  ELIMINATE (PUT ON RESERVE LIST IN CASE NEEDED)
8 OR MORE	Is your annual household income more than $86,900, less than $86,900, or just about $86,900?	More than  ELIMINATE Less than Just about  ELIMINATE(PUT ON RESERVE LIST IN CASE NEEDED)

VERSION FOR LOW-ACCESS GROUPS (El Paso & San Antonio)

Q13. How far is the nearest grocery store or supermarket from your home?

• Less than 1 mile  eliminate if recruiting for LOW-access group [thank respondent politely]

• 1-2 miles  eliminate if recruiting for LOW-access group [thank respondent politely]

• 3-4 miles  eliminate if recruiting for LOW-access group [thank respondent politely]

• 5-10 miles  eliminate if recruiting for LOW-access group [thank respondent politely]

• More than 10 miles

VERSION FOR HIGH-ACCESS GROUPS (Houston & Austin)

Q14. How far is the nearest grocery store or supermarket from your home?

• Less than 1 mile

• 1-2 miles

• 3-4 miles

• 5-10 miles

• More than 10 miles  eliminate if recruiting for HIGH-access group [thank respondent politely]

Q15. How do you typically get to the place where you usually get your groceries? [DO NOT READ RESPONSES. Check all options that the participant names.]

• OWN CAR

• BORROW A CAR

Soft quota of 2-3 respondents who walk, use public transportation, or take a taxi or other rideshare program:

• WALK

• PUBLIC TRANSPORTATION (BUS, SUBWAY)

• TAXI OR OTHER RIDESHARE PROGRAM (E.G., UBER, LYFT)

• ORDERS ONLINE FOR DELIVERY no quota, but no more than one in group

• OTHER_[SPECIFY: _________]

Q16. About how many minutes does it take you to get to the place where you usually get your groceries? [DO NOT READ RESPONSES. Check all options that the participant names.]

• LESS THAN 10 MINUTES

• 10-19 MINUTES

• 20-29 MINUTES

• 30-39 MINUTES

• 40-49 MINUTES

• 50-59 MINUTES

• 60 MINUTES OR MORE

Q17. What zip code do you live in?

Q18. Do you work outside the home?

• Yes, full-time

• Yes, part-time

• No

Thank you for answering these questions. We would like to invite you to participate in a focus group to discuss thoughts about food and eating habits with about 8 other participants. The discussion will last approximately 90 minutes. The discussion will be video- and audio-taped, and also observed by members of a research team. Your participation and everything you say during the discussion will remain secure and your personal identifying information will not be included in any reports. At the conclusion of the focus group, you will receive $75 as a token of appreciation for your participation. Are you interested in participating in this focus group?

• Yes

• No  [Thank the person for his/her time]

We’d like you to bring a recipe for the dish you cook most often. Are you willing to bring it and discuss it in the group?
BRINGING A RECIPE IS OPTIONAL; RESPONDENTS WHO SAY NO ARE STILL ELIGIBLE.

• Yes

• No

I’m glad that you will be able to join us! The focus group will take place on (Day), (Date), at [X:00 p.m.] at [site location].

Will you be available to participate at this time?

• Yes

• No  [Thank the person for his/her time]

I would like to send you a confirmation email or letter containing directions to the facility. In order to do so, could you please tell me the best way to reach you (e.g., email and/or a phone number)?

Name:______________________________________

Address (if needed to reach participant): ___________________________________________________

City:_______________________ State:_________ Zip:_____________

or

Email (if needed to reach participant):_________________________________

Phone (if needed to reach participant):_______________________

Date of focus group:__________________ Time:________________

We are only inviting a few people, so it is very important that you notify us as soon as possible if for some reason you are unable to attend. Please call [recruiter] at [telephone number] if this should happen. We look forward to seeing you on [date] at [time]. If you wear glasses to read or watch TV, please bring them with you to the focus group. IF AGREED TO BRING RECIPE, Please also remember to bring a recipe for the dish that you cook most often.

[Remind participants to bring recipe when confirming attendance.]

1 Texas Health and Human Services. (2019) Eligibility and Benefits by Federal Poverty Level (FPL). Accessed on December 4 2019: https://dshs.texas.gov/genetics/pdf/EligibilityandBenefitsbyFPL.pdf

2 Cutoffs based on 200%FPL, as listed on: https://aspe.hhs.gov/poverty-guidelines. Cutoff of 200%FPL based on benefits eligibility for Texas, as listed on: https://dshs.texas.gov/genetics/pdf/EligibilityandBenefitsbyFPL.pdf