CNPP OMB Cover Memo

Memorandum

Date: May 5, 2015

To: Julie Wise, OMB Desk Officer, Food and Nutrition Service

Through: Rachelle Ragland Green, Food and Nutrition Service, Information Clearance Officer; Ruth Brown OCIO Desk Officer

From: Jessica Larson, Senior Nutritionist, Center for Nutrition Policy and Promotion (CNPP)

USDA – Food, Nutrition and Consumer Services

Re: Under Approved Generic OMB Clearance No. 0584-0523 Request for Approval to Perform Formative Research to Test Messages Developed to Help Communicate 2015 Dietary Guidelines Recommendations

Center for Nutrition Policy and Promotion (CNPP) of the USDA Food, Nutrition, and Consumer Services is requesting approval for formative research under Approved Generic OMB Clearance No. 0584-0523.

This request is to acquire clearance to conduct formative research in order to develop message concepts to communicate recommendations stemming from the Dietary Guidelines for Americans 2015.

The following information is provided for your review:

1. Title of the Project: CNPP Message Concept Focus Groups

2. OMB Control Number and Expiration Date: 0584-0523, January 31,2016

3. Public Affected by this Project: Individuals and Households. Americans between the ages of 18 and 49 (Generational cohorts X and Y) with a BMI between 18.6 and 35. Participants will include both English- and Spanish-speaking individuals, and a mix of gender, race and income. See section 7, Project Purpose, Methodology & Formative Research Design for a description of the number of participants necessary for the research methodology. The definitions of the public affected by this project are identified in the screening instruments (see Appendices A-1 and A-2).

4. Number of Respondents:

CNPP will recruit approximately 2,016 individuals and households. We estimated that 1,512 (non-respondents) will not participate in whole or in part and 504 will go on to participate as respondents. The total estimated number of participants is 192. Responder estimates per activity is based on anticipated response rates of 19% (192/1,008). Two hundred and eighty-eight (288) individuals will be recruited to participate in these focus groups. Of these, 192 (66.7%) will participate in focus group discussions.

Table 1: Number of respondents

Instrument	Total Number of Participants	Number of respondents	Proportion of Responders	Number of non-respondents	Proportion of non-respondents
Screening (Focus Groups)
Screening for English Language Groups	1008	252	25%	756	75%
Screening for Spanish Language Groups	1008	252	25%	756
Focus Groups
Confirmation and follow up	504	288	57%	216	43%
Group Discussion (English)	144	96	67%	48	33%
Group Discussion (Spanish)	144	96	67%	48	33%
	2016	504		1512

CNPP, along with our contractors, will contact approximately 1,008 individuals and households to recruit:

• 144 participants for 12 focus groups in English. Each group will have eight participants, with 12 recruited for each group to assure quorum.

• 144 participants for 12 focus groups in Spanish. Each group will have eight participants, with 12 recruited for each group to assure quorum.

For all focus groups, 12 participants will be recruited for each of the 12 groups to seat a quorum of eight. Recruitment criteria and methodology are discussed in the Recruitment section below. The burden for focus group participation is based on the number of participants seated (96).

5. Time Needed Per Response:

Participants will engage in a 2-hour, in-person group discussion addressing topics outlined in the moderator guide (Appendices C-1 and C-2).

The table summary of estimated burden hours is presented below.

Table 2: Burden Hours

6. Total Burden Hours on Public: 668

7. Project Purpose, Methodology, and Formative Research Design:

Background

This year, the U.S. Departments of Agriculture and of Health and Human Services will release the Dietary Guidelines for Americans 2015 policy document, which is the cornerstone of Federal nutrition programs. Updated every five years, the Dietary Guidelines for Americans (DGA) serve as the nation’s authoritative recommendations regarding recommended calorie consumption, making informed food choices, and being physically active to attain and maintain a healthy weight, reduce risk of chronic disease, and promote overall health. Recommendations from the DGA are intended for Americans ages 2 years and older, including those at increased risk of chronic disease.

The USDA Center for Nutritional Policy and Promotion (CNPP) is collaborating with HHS’s Office of Disease Prevention and Health Promotion (ODPHP) to develop communication strategies to promote healthy eating among Americans based on the upcoming DGA. Specifically, CNPP is tasked with developing communication strategies for the general population to encourage dietary practices recommended by the DGA, as well as physical activity.

As is the case with the release of the DGA, CNPP must ensure that the specific consumer recommendations (i.e., message concepts) that stem from the DGA communicate information clearly, as intended. In other words, it must minimize the possibility of misinterpretation. Previous research to inform the development of such consumer-facing messaging focused on each message, individually. For example, research participants were asked to evaluate several ways to communicate the idea, “Make half your plate fruits and vegetables” to inform the final wording. This year, however, represents an important additional goal for the DGA recommendations.

In 2015, CNPP and ODPHP determined that in addition to communicating DGA recommendations clearly, this concept messaging must also communicate the notion of holistic dietary patterns—the idea that consumers should use the information from all of the DGA recommendations to help them make better nutrition decisions now, and into the future. Finally, CNPP also desires to better understand what kinds of their DGA-related tips best help/encourage consumers to make healthy choices when it comes to the foods and beverages they consume.

The approval of this information collection is necessary for CNPP to meet these aforementioned objectives:

• Identify what message concepts can best summarize the idea of a dietary pattern and encourage consumers to think about nutrition decisions, writ large.

• As with previous Dietary Guidelines-related research, this information collection must also identify how best to communicate new message concepts stemming from this year’s DGs, such as messaging around added sugars and sodium consumption.

• Uncover what kind of helpful hints/tips consumers find realistic and applicable to their everyday lives.

Following the best practices of consumer messaging research, the first, qualitative phase of this research plan will be formative in nature. Focus groups among individuals of varying demographic backgrounds and who represent different dietary habits will ascertain what concepts provide the greatest opportunity to explain and promote healthy dietary patterns via the 2015 DGA consumer recommendations.

It is important to note that the research detailed in this submission represents only the first part of the overall research program. Later this year, after CNPP refines DGA messaging stemming from this research, CNPP will submit a quantitative research protocol for OMB approval to determine which message concepts most effectively communicate as intended among key audiences.

Purpose

Strong message concepts is a function of two key factors: clear expression of the necessary information and an understanding of the audience that needs to hear and internalize it. USDA and HHS have a clear plan to develop the Dietary Guidelines and determine the most crucial information to share with consumers, but without a better understanding of how consumers might hear or interpret the message concepts, it may fall on deaf ears. Consumer-facing research will provide the remaining intelligence needed to increase the likelihood of success.

The information collected during this initial qualitative phase of the research will provide the research and communication teams with initial understanding of:

• How consumers respond to message concepts designed to communicate the importance of keeping overarching dietary patterns in mind when making nutrition-related decisions;

• Obstacles to getting consumers to think about DGA recommendations as a whole (versus individually);

• What words and phrases most effectively communicate new DGA recommendations; and

• What kinds of nutrition-related tips consumers find most effectively in helping them to adopt DGA recommendations.

Finally, these groups will also provide invaluable information regarding the language consumers use to discuss complicated nutrition concepts such as “dietary patterns,” “power calories,” and “empty calories.” This information will enable CNPP to refine message concepts so that consumers can understand it and deem it authentic.

Methodology/Research Design

Recruitment

The target population for this study is defined in terms of generational cohorts: Generation Y (18 to 32 year olds) and Generation X (33 to 49 year olds). Furthermore, all screening criteria will exclude individuals with either a BMI over 34.9 or under 18.5. We will recruit both English-speaking and Spanish-speaking participants for the focus groups.

Over all we estimate 2,016 will be contacted for this data collection. We further estimate that 1,008 individuals will be screened to recruit 144 individuals for the Spanish-language groups. In addition, 1,008 individuals will be screened to recruit 144 participants for the English-language groups. We plan for 96 English-speaking individuals and 96 Spanish-speaking individuals to participate in the groups. Thus, 12 individuals will be recruited to ensure that 8 participate in each focus group (24 focus groups in total).

The Spanish-speaking participants will be segmented by region of origin (Mexican, Central American and Caribbean or South American), income and BMI index (normal range vs. overweight/obese). The English-language focus groups will be segmented by generational cohort, race (Black/African American vs. other), income, and BMI. To meet the segmentation requirements, the recruitment will oversample African American individuals.

A multi method strategy will be used to recruit participants. This will involve the use of randomly selected household lists in the target geographic areas, use of databases of individuals available from focus group facilities, and outreach to community and faith-based organizations. The outreach activities are especially vital for recruitment of lower income and Hispanic monolingual participants. All potential respondents will be contacted and screened by phone. The screening instruments (English and Spanish) are included in Appendices A-1 and A-2.

During the screening process, we will obtain verbal consent and verbal commitment to participate in the assigned focus groups, and participants will complete consent forms prior to any follow up research activities (see Appendices D-1 and D-2).

Confirmation of Participation

A follow-up letter of confirmation will be mailed and/or emailed to individuals who have agreed to participate in each phase of research. The letter will thank the participant for agreeing to be part of the focus group and reiterate privacy statements (Appendices B-1 [English] and B-2) [Spanish]). It will also remind participants of the date, time and location of the groups, as well as provide other information about scheduling, directions, etc., as needed. All confirmation letters will include contact information for the contractor.

Incentives

CNPP will provide an incentive of $100 for participating in a two-hour, in-person focus group.

We understand that the OMB guidance about incentives for participation in research is based on the principles of the 2006 memo: Guidance on Agency Survey and Statistical Information Collections (hereby referred to as the 2006 memo). The 2006 memo explicitly states its purpose as “to improve the quality of Federal surveys and statistical information.” The research proposed here is exclusively qualitative. Participation in focus groups requires substantial commitment on the part of the respondents. For the proposed focus groups, participants must make a commitment to attend the discussion at certain time on a specific date. And, incentives have been considered a standard practice in conducting qualitative research (see, for instance, the CDC General Guidelines for Focus Groups)¹. The justifications for the incentive amounts proposed for this research are based on the circumstances mentioned in the 2006 memo when an agency may provide survey participants with incentives. In our opinion these circumstances apply to the qualitative research proposed here and are detailed, below.

Data Quality

The purpose of the research described here is to offer guidance to CNPP to develop messaging pertinent to the 2015 Dietary Guidelines. The 2015 Dietary Guidelines will serve as a framework to improve the nutrition and ultimately the health of all Americans, including those who do not show a strong interest in the topic of nutrition. It is therefore imperative that the qualitative insights are made by hearing the opinions of a diverse range of the American public. Limiting incentives would do an irreparable harm to this objective by increasing non-response bias. Offering no incentive or a small incentive will limit participation to individuals with personal or vested interest in the topic matter thus limiting the range of opinions expressed in the focus group discussions. In addition, this would also potentially exclude sections of the population who cannot afford to attend the groups, either due to the cost of childcare or the cost of missing work (see below). This, in turn, would limit the qualitative insights gathered through focus group discussions to the opinions of the very select individuals willing to participate in the research without or with very low incentives, severely biasing the information needed to develop effective messaging. The suggested incentive amounts will assure participation by the broader spectrum of American public and thus decrease non-response bias.

Complex study design

In qualitative research, the complexity of the research “design” is best translated as the specificity of the recruitment criteria. The study employs highly restrictive criteria for participation: English-language groups are segmented by income, race, generational cohort and Body Mass Index (BMI). Spanish-language groups are segmented by country of origin, income and BMI. Proposed incentives are more likely to secure the participation of individuals meeting the screening requirements, making recruitment more effective and thus saving government money in recruitment costs.

Improved coverage of specialized respondents, rare groups, or minority populations

Both English-language and Spanish-language groups will include low-income participants. The research team for this effort was selected largely due to their vast experience in conducting groups among low-income populations. In the similar work they have conducted among this audience, low-income participants have been burdened with additional transportation and child care costs which have prevented them from participating in focus groups or led to high no-show rates.

For this effort, we anticipate that most of our low-income participants will be parents of young children. Although the participant burden for focus groups is 120 minutes (two hours), a typical participant may spend an additional half hour at the facility (e.g., arriving earlier to check in and waiting for incentives after the group). Furthermore, a participant may have to commit an hour to travel to and from the facility. In all, the actual time commitment for the focus group participation is closer to three hours. In order to ensure the participation of lower-income participants in these previous research efforts, incentives were necessary to cover the childcare and transportation costs as well as the cost of competing job opportunities.

For this effort, the childcare costs are estimated at $15 per hour. This estimate is based on the estimated cost for babysitting services for 1-2 children in proposed research locations suggested by Care.com (http://www.care.com/babysitting-rates) presented in Table 3. This estimate is slightly less than the average suggested rate across locations for the care of two children, and slightly more than the average suggested rate for the care of one child. In total, we recommend that $52.50 of the incentive amount cover childcare costs.

Table 3: Estimated costs for childcare

Location	Hourly Cost: 1 Child	Hourly Cost: 2 Children
Baltimore, MD	14.50	15.50
Birmingham, AL	13.50	15.00
Los Angeles, CA	15.00	16.50
Dallas, TX	14.00	15.00
Average Cost	14.25	15.50

We also recommended a transportation allowance of $10. This incentive will fully cover cost of public transportation fares in proposed locations, and any incidental expenses such as parking at public transportation hubs (e.g., Park and Ride).

Furthermore, the show rates among low-income participants are often affected by available opportunities to earn additional income (e.g., extra hours at work or side jobs) that pay more than the typical incentive. The groups to be conducted during this effort will be held in the evening, during such times where many participants have the option to earn extra income (e.g., obtaining additional shift work, going to their second job). Therefore, incentives must make economic sense to the participants in order to be effective in securing their attendance and participation.

The average hourly wages for this group of participants is estimated to be $7.88 per hour. This estimate is based on the minimum wages as stated by the United States Department of Labor (http://www.dol.gov/whd/minwage/america.htm) in the proposed research locations presented in Table 4. In total, we recommend that $19.70 of the incentive amount cover competitive labor wages. This total is based off of a participant spending two hours at the focus group and a half an hour checking in and waiting afterwards for incentives.

Table 4: Minimum wages per location

Location	Hourly Minimum Wage
Baltimore, MD	8.00
Birmingham, AL	7.25
Los Angeles, CA	9.00
Dallas, TX	7.25
Average Cost	7.88

To secure participants for the focus groups and ensure a response rate that delivers the high data quality required, the research team suggests offering a total incentive of $100 to compete with other familiar job opportunities.

Equity

There are two issues pertaining to equity. First, as noted in the 2006 memo, if incentives are used, these should apply to all participants in research. Therefore, the recommended incentives must be applied to all participant segments, regardless of the incidence. The second issue is equity in terms of customary incentives offered for participation in non-Federal research. We anticipate an overlap among the participants recruited for this projects in terms of their participation in Federally sponsored and non-Federally sponsored research. The proposed incentive amounts are already slightly lower than industry average. Even lower incentives may lead to resentment among participants in this study as they compare the incentive amount to the customary incentives they could have received for participating in similar research and therefore a negative perception of all Federally sponsored research.

For these reasons, we set the incentive rates to $100 for respondents who participate in these two-hour sessions.

Focus Group Content

A trained moderator will facilitate the discussions as described in the Focus Group Moderator's Guide (Appendices C-1 [English] and C-2 [Spanish]).

Consent

Written consent will be obtained from the participants prior to the beginning of the focus group discussions. The consent forms will reflect the content of the focus groups, inform about the use of the data, outline safeguard procedures for private information discussed or collected and inform about audio and video recording. Consent materials will be made available in Spanish for Spanish-speaking participants and are included in this submission. Consent forms are appended in Appendices D-1 and D-2.

Data Analysis

The focus groups will be audio-recorded (with respondent permission), and the information collected will be used to inform the main informational objectives of the study, as noted above. Focus group respondents will be informed that the sessions are recorded. Notes taken while observing the focus group sessions and the transcripts of the recordings will be the primary methods of data collection for qualitative data. Transcripts and notes will be reviewed for recurring themes stated across multiple groups and respondents. Differences will be assessed across groups, locations, and audiences will be noted as appropriate. Since this work is qualitative, findings will be considered descriptive and directional, but not definitive. No attempt will be made to generalize findings as nationally representative or statistically valid.

Outcomes/Findings

Information and formative input gathered from specific target audiences through the research will help identify message concepts and content that is most effective at communicating DG-related information to target audiences and that compels them to make better nutritional choices. CNPP may decide to publish summary research findings either electronically or in print, but such documents will not include information that personally identifies any of the research participants. Our Contractors will submit a final report will be submitted to CNPP. The report will be based on qualitative approaches to summarizing verbatim data. No statistical summaries or analyses will be conducted.

8. Confidentiality:

CNPP and contractors will follow procedures for maintaining safeguards consistent with the Privacy Act during all stages of data collection. A system of record notice (SORN) titled FNS-8 USDA/FNS Studies and Reports in the Federal Register on March 31, 2000, Volume 65, Number 63, and is located on pages 17251-17252 discusses the terms of protections that will be provided to respondents.

Using forms in Appendices D-1 and D-2, all participants will receive a privacy statement along with the consent form. The confidentially statement will inform the participants that all opinions they provide will be private and none of their responses will be associated with personally identifiable information (PII). Participants will also be informed that findings will be presented as a summary. If representative quotes are used in the summaries, the authors of the quote will be identified only by gender and age cohort.

Additional steps employed to notify the respondents about their privacy are as follows:

• As part of the conditions of employment, all trained staff working on the project have signed a non-disclosure agreement (NDA) (Appendix E-1) prohibiting them from discussing any information about the research studies they work on with anyone not involved with the project, especially discussing or releasing personally identifiable information (PII).

9. Federal Costs: $998,319.67

10. Research Tools/Instruments:

• Appendix A-1: FOCUS GROUP SCREENER - ENGLISH

• Appendix A-2: FOCUS GROUP SCREENER - SPANISH

• Appendix B-1: FOCUS GROUP CONFIRMATION FORM - ENGLISH

• Appendix B-2: FOCUS GROUP CONFIRMATION FORM - SPANISH

• Appendix C-1: FOCUS GROUP MODERATOR’S GUIDE - ENGLISH

• Appendix C-2: FOCUS GROUP MODERATOR’S GUIDE - SPANISH

• Appendix D-1: CONSENT FORM – ENGLISH

• Appendix D-2: CONSENT FORM – SPANISH

• Appendix E-1: CONFIDENTIALITY AGREEMENT – ENGLISH

1 http://www.cdc.gov/nccdphp/dnpa/socialmarketing/training/pdf/focusgroupguidelines.pdf

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