Healthy Claims Focus Group

OMB No: 0910-0497 Expiration Date: 09/30/2017

Paperwork Reduction Act Statement: The public reporting burden for this collection of information has been estimated to average 5 minutes per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to [email protected].

Appendix II

“Healthy” Claim Focus Groups

Participant Screener

Notes to facility:

• Please do not call people who have done a focus group or other interview-based research in the last 6 months.

• Please do not call people who have ever done 5 or more focus groups.

• When calling potential participants, recruiters should use general interactions throughout all calls to make judgements about each person’s ability and willingness to participate in a focus group discussion. We are looking to recruit a diverse group of participants, not just individuals who are especially talkative and articulate. Although everyone will be expected to participate in the discussion, there is no expectation that everyone will answer every question. All participants will need to be comfortable conversing in English.

Recruiting Goals:

• All participants must be able to read, understand, and speak English.

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

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

Study Protocol:

• Each group will last approximately 2 hours (including a 90-minute discussion plus time needed for signing in before the group starts and signing out after the group ends).

• Groups will be audio- and video-taped and live-streamed.

• Signed Informed Consents will be processed at sign-in and a verbal consent will be obtained before the start of the discussion.

• The identity of the participants will be kept secure in accordance with the Privacy Act.

• Groups will be observed by staff from the U.S. Food and Drug Administration.

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

Group Composition and Location:

Group No.	Location	Level of Education
Group 1 & 2	Northeast/Mid-Atlantic/South	Higher
Group 3 & 4	Northeast/Mid-Atlantic/South	Lower
Group 5 & 6	West Coast	Higher
Group 7 & 8	West Coast	Lower
Group 9 & 10	Mid-West	Higher
Group 11 & 12	Mid-West	Lower

SCRIPT:

Hello Mr./Ms. __________________________________, 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 recruiting for an upcoming focus group in which participants will be asked to share their thoughts and experiences about eating certain foods. Participants in this study will receive $75 token of appreciation for participating in the focus group. Let me assure you that this is a legitimate research study. I am not trying to sell anything.

Are you interested in participating?

• Yes  continue

• No  eliminate [thank respondent politely]

Would you mind answering a few questions? This will only take a few minutes of your time.

• Yes  continue

• No  eliminate [thank respondent politely]

DETERMINE GENDER [ENSURE APPROXIMATELY 2 MALES PER GROUP]

• Male  continue [recruit no more than 5 males per group to seat no more than 3 per group]

• Female  continue

The focus group will be conducted in English. Are you comfortable reading and speaking English?

• Yes  continue

• No  eliminate [thank respondent politely]

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

• A Market Research Firm  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]

Thinking about your eating habits in general, how healthy is your overall diet?

• Excellent, Very Good, Good, Fair  continue

• Poor, Don’t Know, Refused  eliminate [thank respondent politely]

I am going to read some age categories, could you please tell me in which category your age falls? [RECRUIT A MIX FOR EACH AGE CATEGORY WITHIN EACH GROUP AND ACROSS STUDY][SOFT QUOTA OK BUT ENSURE NO ONE AGE GROUP IS OVER-REPRESENTED]

• Under 18 years old  eliminate [thank respondent politely, ask to speak with someone at least 18 years old]

• 18-30  continue

• 31-44  continue

• 45-64  continue

• 65+  continuE

Are you the person who does at least half of the grocery shopping for your household?

• Yes  continue

• No  eliminate [thank respondent politely]

How often do you prepare the main meal in your household in a typical week? Do you typically prepare the main meal…

• 6 or 7 days a week  continue

• 4 or 5 days a week  continue

• 2 or 3 days a week  continue

• 1 day a week  continue

• Never?  eliminate [thank respondent politely]

What is the highest level of education that you have completed? [READ ALL ANSWER OPTIONS. RECRUIT A MIX WITHIN EACH GROUP AND ACROSS STUDY]

• Less than high school  recruit to lower ed group

• High school graduate or GED  recruit to lower ed group

• Technical/vocational school  recruit to lower ed group

• Some community college  recruit to lower ed group

(towards an Associate’s degree or other

community college degree)

• Community college degree (for example, Associate’s degree)

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• Some college (  recruit to higher ed group

towards Bachelor’s degree)

• College degree (Bachelor’s degree  recruit to higher ed group

• Advanced degree (postgraduate degree)  recruit to higher ed group recruit no more than ABOUT 5 per group TO SEAT NO MORE THAN ABOUT 3 PER GROUP]

Are you of Hispanic or Latino origin? [ENSURE ABOUT 2 PER GROUP AS REFLECTIVE OF THE AREA]

• Yes  continue

• No  continue

What is your race? I am going to read several categories of race. You may choose one or more categories. Are you…? [Recruit a diverse group reflective of the area.]

• White

• Black or African American

• Asian

• Native Hawaiian or other Pacific Islander

• American Indian or Alaska Native

I am going to read some income categories; could you classify your annual household income to one of these categories? [RECRUIT A MIX PER GROUP]

• Less than $25,000 per year

• $25,000 to less than $50,000 per year

• $50,000 to less than $75,000 per year

• $75,000 and over per year

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FINALIZING SCREENER QUESTIONS FOR ALL GROUPS

Thank you for answering these questions. We would like to invite you to participate in a focus group with about eight other participants to discuss issues relating to eating habits and health. The discussion will last approximately an hour and a half. The discussion will be video- and audio-taped, and also observed by researchers. Your participation and everything you say during the discussion will remain secure in accordance with the Privacy Act and your personal identifying information will not be included in any reports. At the conclusion of the focus group, you will receive $75.00 as a token of our appreciation for your participation. Are you interested in participating in this focus group?

• Yes [CONTINUE]

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

I’m glad that you will be able to join us! The focus group will take place on (DAY), (DATE), at [6:00 or 8:00 p.m.] at [SITE LOCATION].

Will you be available to participate at this time?

• Yes [CONTINUE]

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

I would like to send you a confirmation letter and directions to the facility. In order to do so, could you please tell me the best way of contacting you:

______________________________________________________________________________

[INSERT CONTACT INFORMATION]

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 use reading glasses, please bring them with you to the focus group.