OMB Justification Memo

Memorandum

Date: April 21, 2015

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

Through: Rachelle Ragland-Greene, Food and Nutrition Service, Information Collection Clearance Officer, Planning & Regulatory Affairs and

Ruth Brown, United States Department of Agriculture, Office of Chief Information Office, Departmental Clearance Desk Officer

From: Valery Soto, Nutritionist, Supplemental Food Programs Division

Food and Nutrition Service, USDA

Re: Under Approved Generic OMB Clearance No. 0584-0524

Request Approval to Perform Research for Loving Support Campaign Update (Phase 1)

_______________________________________________________________________________

The Food and Nutrition Service (FNS) of the USDA Food, Nutrition, and Consumer Services is requesting approval for formative research under Approved Generic OMB Clearance No. 0584-0524.

This request is to acquire clearance for expert in-depth interviews to inform the update of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Loving Support Makes Breastfeeding Work campaign. This package addresses initial research that will help FNS focus resources on strategies that are most likely to resonate, motivate, and appeal to the target audience. Specifically, FNS seeks to conduct in-depth interviews with WIC peer counselors, WIC state and local breastfeeding coordinators and staff, breastfeeding subject matter experts, and home-visiting nurses/midwives and community-based doulas to gather feedback on breastfeeding knowledge, barriers, motivations, and opportunities among WIC mothers and their supporters. This package includes the recruitment language and in-depth interview guides.

This package represents the first round of formative research. Refinements to the social marketing approach will be made based on feedback from this round of research and will inform subsequent formative research phases.

The following information is provided for your review:

1. Title of Project: Formative Research and Educational Materials Development for Updates to the Loving Support Makes Breastfeeding Work Campaign

2. Control Number: 0584-0524, Expires 06/30/2016

3. Public affected by this Project: Individuals/Households and respondent groups identified below:

• WIC peer counselors who provide support locally to WIC mothers and families

• WIC state and local breastfeeding coordinators and staff who administer WIC breastfeeding support activities, including the peer counseling program and the Loving Support campaign, at the state and local level

• Breastfeeding subject matter experts who conduct research and develop programs to promote breastfeeding at the local, state, and national level.

• Home-visiting nurses/midwives and community-based doulas who serve WIC mothers and families.

Out of108 respondents identified 60 respondents will initially be contacted and screened through direct referral, 20 respondents will participate in the in-depth interviews.

Please refer to the Methodology/Research Design section of this document for further logistical details for each audience. All interviews will be conducted in English.

4. Number of respondents:

	Total Number of Participants	Number of Responders	Proportion of Responders	Number of Non-Responders	Proportion of Non-Responders
Email Recruitment Invitation*
WIC peer counselors	24	6	25%	18	75%
WIC state breastfeeding coordinators	8	4	50%	4	50%
WIC local breastfeeding coordinators and staff	8	4	50%	4	50%
Breastfeeding subject matter experts	8	4	50%	4	50%
Home-visiting nurses/midwives and community-based doulas	20	2	10%	18	90%
Email Confirmation and Scheduling
WIC peer counselors	6	6	100%	0	0%
WIC state breastfeeding coordinators	4	4	100%	0	0%
WIC local breastfeeding coordinators and staff	4	4	100%	0	0%
Breastfeeding subject matter experts	4	4	100%	0	0%
Home-visiting nurses/midwives and community-based doulas	2	2	100%	0	0%
In-Depth Interviews
WIC peer counselors	6	6	100%	0	0%
WIC state breastfeeding coordinators	4	4	100%	0	0%
WIC local breastfeeding coordinators and staff	4	4	100%	0	0%
Breastfeeding subject matter experts	4	4	100%	0	0%
Home-visiting nurses/midwives and community-based doulas	2	2	100%	0	0%
Totals	108	60		48

5. Time needed per response:

Time Needed Per Email Recruitment Invitation*

Audience	Time (minutes)	Time (hours)
WIC peer counselors	10	0.17
WIC state breastfeeding coordinators	10	0.17
WIC local breastfeeding coordinators and staff	10	0.17
Breastfeeding subject matter experts	10	0.17
Home-visiting nurses/midwives and community-based doulas	10	0.17

*The time per response is an average of the response per respondent. Respondents may be terminated by FNS due to the response to a question or respondent may choose to terminate at any point during the screening (before the first question, after the introduction, or at the end of the screener).

Time Needed Per Email Confirmation and Scheduling

Audience	Time (minutes)	Time (hours)
WIC peer counselors	10	0.17
WIC state breastfeeding coordinators	10	0.17
WIC local breastfeeding coordinators and staff	10	0.17
Breastfeeding subject matter experts	10	0.17
Home-visiting nurses/midwives and community-based doulas	10	0.17

Time Needed Per In-depth Interview

Audience	Time (minutes)	Time (hours)
WIC peer counselors	60	1
WIC state breastfeeding coordinators	60	1
WIC local breastfeeding coordinators and staff	60	1
Breastfeeding subject matter experts	60	1
Home-visiting nurses/midwives and community-based doulas	60	1

6. Total Burden Hours on Public: 30.7 rounded up to 31 annual burden hours

				Respondents					Non-Respondents
Affected Public	Respondent Type	Activity	Sample Size	No. Respondents	Frequency of Responses	Est. Total Annual Responses per Respondent	Hours per Response	Total Burden Hours	No. Non-Respondents	Frequency of Responses	Est. Total Annual Responses per Respondent	Hours per Response	Total Burden Hours	TOTAL BURDEN HOURS
State, local, or tribal agency staff	WIC peer counselors	Recruitment email*	24	6	1	6	0.17	1	18	1	18	0.08	1.5	2.5
	WIC peer counselors	Confirmation and scheduling	6	6	1	6	0.17	1	0	0	0	0	0	1
	WIC peer counselors	Interview	6	6	1	6	1	6	0	0	0	0	0	6
	WIC state breastfeeding coordinators	Recruitment email*	8	4	1	4	0.17	0.67	4	1	4	0.08	0.33	1
	WIC state breastfeeding coordinators	Confirmation and scheduling	4	4	1	4	0.17	0.67	0	0	0	0	0	0.67
	WIC state breastfeeding coordinators	Interview	4	4	1	4	1	4	0	0	0	0	0	4
	WIC local breastfeeding coordinators/staff	Recruitment email*	8	4	1	4	0.17	0.67	4	1	4	0.08	0.33	1
	WIC local breastfeeding coordinators/staff	Confirmation and scheduling	4	4	1	4	0.17	0.67	0	0	0	0	0	0.67
	WIC local breastfeeding coordinators/staff	Interview	4	4	1	4	1	4	0	0	0	0	0	4
	State, local, tribal agency burden subtotal			42		42		18.7	26		26		2.17	20.8
Individuals (not employed by state, local, or tribal agencies)	Breastfeeding subject matter experts	Recruitment email*	8	4	1	4	0.17	0.67	4	1	4	0.08	0.33	1
	Breastfeeding subject matter experts	Confirmation and scheduling	4	4	1	4	0.17	0.67	0	0	0	0	0	0.67
	Breastfeeding subject matter experts	Interview	4	4	1	4	1	4	0	0	0	0	0	4
	Home-visiting nurses/midwives, community-based doulas	Recruitment email*	20	2	1	2	0.17	0.33	18	1	18	0.08	1.5	1.83
	Home-visiting nurses/midwives, community-based doulas	Confirmation and scheduling	2	2	1	2	0.17	0.33	0	0	0	0	0	0.33
	Home-visiting nurses/midwives, community-based doulas	Interview	2	2	1	2	1	2	0	0	0	0	0	2
	Individuals burden subtotal			18		18		8	22		22		1.83	9.8
TOTAL				60		60		26.7	48		48		4	30.7

*Includes burden for those not responding to the recruitment email. See narrative under sections 4 and 5.

6. Project Purpose, Methodology and Design:

Background

This cooperative agreement is made under the authority of Public Law 113-76, the Consolidated Appropriations Act, 2014, for the purposes specified in section 17(h)(10)(B) of the Child Nutrition Act of 1966, as amended (42 U.S.C. 1786(h)(10)).

The purpose of the agreement is to update the existing USDA national breastfeeding campaign, Loving Support Makes Breastfeeding Work (Loving Support), which is based on a comprehensive social marketing plan that includes formative research, strategy development, and program development approved September 2, 2014 (ICR reference #201407-0584-002). The Formative Research and Educational Materials Development for Updates to the Loving Support Makes Breastfeeding Work Campaign Cooperative Agreement will build on the successes of the existing Loving Support campaign to inform, motivate, and persuade the audience in an effective manner that continues to increase breastfeeding rates among WIC participants and increase support for breastfeeding among those who most influence breastfeeding mothers (their family and friends, health care providers, WIC staff, and relevant community partners). The main emphasis of the social marketing plan will focus on:

• Updating formative research/market research

• Developing new educational messages that are properly framed and tested

• Developing campaign strategies

• Updating current campaign promotional materials and developing new campaign promotional materials

These updates should use the original findings of the initial campaign as a basis but be reflective of the current needs and perspectives of the primary and secondary audiences.

To build upon what FNS has learned through years of breastfeeding promotion, these formal expert interviews with WIC peer counselors, WIC state and local breastfeeding coordinators and staff, breastfeeding subject matter experts, and home-visiting nurses/midwives and community-based doulas will explore barriers to breastfeeding that often differ significantly by community and population. These initial interviews will help uncover community-level and demographic-specific perceptions of benefits and barriers to breastfeeding initiation and continuation among WIC mothers. Additionally, WIC state agencies face unique challenges. Talking to stakeholders at the state and local levels will help the team understand what does and does not work. Aside from the research conducted 15 years ago when the Loving Support campaign was first developed, FNS has not conducted any recent formative research with WIC mothers and breastfeeding supporters.

Purpose

The purpose of the proposed research is to gather valuable insight from the WIC breastfeeding subject matter experts into WIC mothers’ and their supporters’ breastfeeding knowledge and perceptions of barriers, motivations, and opportunities in making breastfeeding decisions. This research will gather input from WIC breastfeeding experts to uncover community-level and demographic-specific perceptions of benefits and barriers to breastfeeding initiation and continuation among WIC mothers.

This research phase will inform subsequent research with WIC mothers and their supporters. The proposed research, combined with the additional research phases, will ultimately inform message and materials development and refinement of the broader social marketing approach.

Methodology/Research Design

The tables below outline the research design and the subsequent sections outline the approach in more detail.

Target Audience	Research Methodology
WIC peer counselors	6 in-depth interviews
WIC state breastfeeding coordinators	4 in-depth interviews
WIC local breastfeeding coordinators and staff	4 in-depth interviews
Breastfeeding subject matter experts	4 in-depth interviews
Home-visiting nurses/midwives and community-based doulas	2 in-depth interviews

Telephone in-depth interviews (IDIs) will be the methodology used for research with WIC breastfeeding experts. The IDI research design allows for in-depth exploration of key motivations and barriers to action around the topics listed in the purpose section above. IDIs with exploratory questions allow us to delve deeper into the topic with each participant and ask follow-up or probing questions in response to interviewee insights. The nature of telephone IDIs allows the participants to feel comfortable talking openly and honestly about their opinions and not feel influenced by others in a group. Additionally, key issues tend to arise quickly with IDIs, allowing us to refine and enhance our exploratory questions for subsequent interviews. IDIs also provide advantages over focus groups in terms of logistics: flexibility in scheduling and location, easier recruitment, and they are faster and cheaper to conduct.

The discussion guides (Attachments A-E) will serve as a tool to facilitate expert interviews.

Design/Sampling Procedures

The sample will include five different audiences as identified above. All respondents within an expert category will be from different state or local WIC agencies. The participants will be comprised of a convenience sample through regional WIC office and WIC/FNS partner referrals using pre-determined screening criteria.

The total estimated number of participants is 68. Responder estimates per expert category is based on anticipated recruitment rates of 25% for WIC peer counselors, 50% for WIC state and local coordinators and staff and breastfeeding subject matter experts, and 10% for home-visiting nurses, midwives, and community-based doulas. We anticipate response rates above these conservative estimates for each of these expert categories. We estimate that 68 participants will receive the initial recruitment invitation. Of these, 20 (29%) participants will receive email confirmations and participate in the in-depth phone interviews.

Site Selection

The recruitment through email invitation with screening criteria (Attachments F-J) and telephone interviews will be conducted with experts across the United States in order to maximize the geographic and ethnic diversity of populations served by the participants. However, experts in the following geographic segments may be targeted for recruitment.

• Louisiana: With the lowest breastfeeding initiation rates in the United States, WIC breastfeeding experts in Louisiana will likely provide insights into the greatest barriers to breastfeeding initiation.

• California: The state has a strong network of WIC breastfeeding support. Some communities, such as Los Angeles, have high rates of primarily Spanish-speaking WIC clients—often with higher rates of initiation than their non-Hispanic counterparts. These WIC experts can provide insight into the motivations and barriers behind breastfeeding in the Latina community. This will help inform the social marketing strategy for the 47 percent of WIC clients who identify as Latina.

• Illinois: Within the Midwest, Illinois reports some of the lowest initiation and six-month breastfeeding rates. With a population that is both urban and rural as well as racially and ethnically diverse, this state may provide insights into a number of our identified audience segments.

Recruitment of Participants

FNS will partner with state and local WIC agencies in each desired location to identify and screen potential expert interviewees (Attachments F-H). State and local WIC agency staff will not incur any additional burden beyond regular job responsibilities for their role in recruiting research participants. FNS, in collaboration with our contractors Hager Sharp, will also reach out to local, state, and federal partners for the recruitment of subject matter experts (e.g., National WIC Association, La Leche League, American Academy of Pediatrics Section on Breastfeeding) and home-visiting nurses/midwives and community-based doulas (e.g., Health Connect One, American College of Nurse-Midwives) (Attachments I and J). The burden associated with recruitment through partner referrals is included in the email recruitment invitation burden hours for the subject matter experts and home-visiting nurses/midwives and community-based doulas.

The research team will email individuals that are most likely to meet the criteria identified for participation and are able to articulate their opinions for the purposes of these interviews. Individuals will be notified that participation is voluntary and there are no penalties for not responding in whole or part. Confirmations, which reiterate privacy statements and voluntary participation, will be sent via email as part of the scheduling process in follow up to the recruitment email. During the recruitment and screening process, we will obtain email consent and email commitment to participate in the interviews; no further consent documentation will be collected.

WIC peer counselors will receive $25 as a token of appreciation as an incentive for their participation in the interviews, that will take place at off-work hours.

Interviews

Each expert interview will last 45-60 minutes. In all interviews, a trained interviewer will facilitate the discussion as described in the interview guides (Attachments A-E). To facilitate data analysis, interviews will be audio recorded and reviewed for recurring themes stated across interviews as well as for direct quotations from experts that help to summarize key findings. Note that no names will be associated with individual participants’ comments.

Data Analysis

FNS and its research partners will use the interviews in this information collection to gather the data necessary to inform the development of subsequent research phases as well as final messages, materials, and the broader social marketing approach. A trained interviewer, professional qualitative analysts, and the FNS team will work together to identify consistencies heard across interviews. Specifically, the analysis team will work to create geographic- and demographic-specific summaries of the discussions to uncover the similarities and differences in perceptions across populations.

Differences across locations and expert types will be noted when appropriate, but given the qualitative nature of this research, findings will be considered descriptive and directional.
No attempt will be made to generalize the findings to be nationally representative or statistically valid.

Upon the completion of analysis, a final report including a summary of the key themes as well as strategic recommendations for message and materials development and refinement of the broader social marketing strategy will be provided to USDA.

Outcome

The data gathered in this research will help FNS to understand WIC mothers’ and supporters’ breastfeeding knowledge as well as perceived barriers, motivations, and opportunities in making breastfeeding decisions. These insights will provide FNS with direction on subsequent research phases and eventually message and materials development and refinement of the social marketing approach to update the Loving Support campaign. FNS may also decide to publish summary findings of the expert interviews either electronically or in print.

6. Confidentiality: System of Record FNS-8, FNS Studies and Reports, published in the Federal Register on 4/25/1991 at 56 FR 19078, covers personal information collected under this study and identifies safeguards for the information collected. Participants will be informed of privacy act provisions before the interview. The privacy 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).

6. Federal Costs: The cost of the FNS employee, Nutritionist series, assigned as project officer with the study is estimated at GS-13, step 5 at $49.32 per hour based off 2080 hours per year $10,258.56 annually estimated 208 hours per year; plus the cost of the FNS Branch Chief, involved in project oversight is estimated at GS-14, step 5 at $58.28 per hour based off 2080 hours per year $1,515.28 annually estimated 26 hours per year for a combined total of 234 hours and $11,773.84.  Federal employee pay rates are based on the General Schedule of the Office of Personnel Management (OPM) for 2015 for the Washington DC locality. Contractor costs are estimated to be 140 hours at GSA rate $122.73, 40 hours at GSA rate $193.79, and 20 hours at GSA rate $83.98 for a combined estimated total of 200 hours and $26,613.40. Other direct costs are estimated to be $350.

6. Research Tools/Instruments:

• Attachment A: Interview Guide for WIC Peer Counselor In-Depth Interviews

• Attachment B: Interview Guide for WIC State Breastfeeding Coordinator In-Depth Interviews

• Attachment C: Interview Guide for WIC Local Breastfeeding Coordinator and Staff In-Depth Interviews

• Attachment D: Interview Guide for Breastfeeding Subject Matter Expert In-Depth Interviews

• Attachment E: Interview Guide for Home-Visiting Nurses/Midwives and Community-Based Doulas In-Depth Interviews

• Attachment F: Email Recruitment Invitation for WIC Peer Counselor In-Depth Interviews

• Attachment G: Email Recruitment Invitation for WIC State Breastfeeding Coordinator In-Depth Interviews

• Attachment H: Email Recruitment Invitation for WIC Local Breastfeeding Coordinator and Staff In-Depth Interviews

• Attachment I: Email Recruitment Invitation for Breastfeeding Subject Matter Expert In-Depth Interviews

• Attachment J: Email Recruitment Invitation for Home-Visiting Nurses/Midwives and Community-Based Doulas In-Depth Interviews

• Attachment K: Incentive Justification

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