App_N.Study Extension SA Letter 8-29-14.V2 PRAO recommendations 11-12-14CMRev

A

OMB Approval No.: 0584-0580

Approval Expires: XX/XX/20XX

PPENDIX N

AGE 3 EXTENSION WIC INFANT AND TODDLER FEEDING PRACTICES STUDY – II

EXTENSION LETTER TO STATES

(ADDENDUM TO CORRESPONDENCE #6)

Dear [NAME OF STATE AGENCY DIRECTOR]:

Thank you for your participation in the WIC Infant and Toddler Feeding Practices Study II, called “Feeding My Baby – A National WIC Study.” We appreciate the cooperation and assistance from you, your staff, and the local WIC sites in implementation of the study. The purpose of this letter is to provide an update on the study, including information about the extension of the study for one additional year. This letter and the attachments are an addendum to the letter you received on [insert date of Correspondence #6].

Study Background and Update

The Feeding My Baby study is being conducted by the U.S. Department of Agriculture, Food and Nutrition Service (FNS) in conjunction with Westat. Westat partners include Altarum Institute; University of California, Los Angeles; and Atkins Center for Weight and Health, University of California Berkeley. The purpose of the study is to document the feeding practices of WIC infants and toddlers and to assess WIC’s impact on those practices. Recruitment of the infants for the study occurred in 80 WIC sites during July through November of 2013. The study site(s) in your State include:

• [insert Local Agency Name, Site Name]

• [insert Local Agency Name, Site Name]

• [insert Local Agency Name, Site Name]

With assistance from State and local agencies and the sites, a total of 4,367 infants were enrolled in the study. This met our goal for enrollment and we appreciate your cooperation and support to achieve that goal. We also accomplished the goals of visiting the 80 sites to collect data on policies and practices, conducting interviews with all State agencies regarding State policies, and obtaining over 800 survey responses from WIC staff in the sites.

Since July 2013, on behalf of FNS, Westat has been conducting phone interviews with the parents/caregivers of the infants in the study to collect a variety of data needed to respond to the study goals and research questions. They are staying in close contact with these parents/caregivers to keep them engaged in the study and participating in the interviews. To date, the retention of infants in the study is close to meeting our expectations. When our Study Liaisons have a hard time contacting a parent/caregiver, they occasionally ask staff in the WIC sites for assistance. We very much appreciate any help they can provide when we make these requests. Currently, we are sending the first request for WIC administrative data (infant measurements and food package type) to each State Agency when all of the infants enrolled in the study in the State have reached 7 months of age. Thank you for responding to these requests when you receive them since these data are critical for the study.

Study Extension

To further the goal of documenting feeding practices of WIC infants and toddlers and assessing the impact of WIC on those practices, FNS is extending the study for one year. There will be no additional recruitment of infants/children for the study. The infants enrolled in the study will be followed through their third birthday with two additional phone interviews conducted at ages 30 and 36 months. This will provide additional data regarding feeding practices, dietary intake and other characteristics as the children mature. It will enable the study to further assess growth patterns relative to feeding practices, to consider environmental factors such as differences between children in childcare and those who are not, and to explore how participation in WIC impacts nutrition and health of children. By continuing the study to the third birthday, we anticipate that the normal attrition from WIC as children age will provide the opportunity to compare children in the study who are on WIC with those who have discontinued taking part in the program. All infants who are enrolled in the study are eligible and encouraged to continue on the study even if they are no longer on WIC. With this extension, the study will end in 12/2018. Table 1 provides an updated study schedule; the highlighted column describes the additional request.

Implementation of Study Extension

To extend the study, we will contact the parents/caregivers of the infants, explain that the study is being continued through their child’s third birthday and ask them to continue participating through that date. They will receive an informational flyer with details regarding the two additional phone surveys between the second and third birthdays and an explanation of the additional incentive amounts they will receive for completing these. Our Study Liaisons will continue to stay in contact with the parents/caregivers to encourage ongoing participation in the study and participation in the phone interviews.

During the additional year, the WIC sites in the study will:

• Occasionally be asked to assist in providing updated contact information for parents/caregivers when they cannot be located through other means. This will occur only when the child is believed to be enrolled in WIC.

• Be asked to conduct weight and height measurements for three year old children who are in the study, but no longer enrolled in WIC. Attachment A provides details regarding this activity, including information about a monetary grant that WIC sites will be offered for conducting these measurements. For children who are being recertified for WIC near the time of their third birthday, we will request the measurements taken for the WIC certification.

During the additional year, the State Agencies in the study will:

• Be asked to respond to one additional WIC administrative data request for measurements and food package type for three year old children in the study. Attachment B is revised to describe additional data request. Parents/caregivers will be asked to provide written consent for release of this data to the study team.

Institutional Review Board (IRB) and Other Approvals

The study extension has been reviewed and approved by the Westat Institutional Review Board (IRB). Westat will submit amendments for the study extension to the State and local agency IRBs that have approved the study.

Table 1: Summary of Data Collection Activities and Schedule

Type of Data or Access Needed	Respondent	Who collects the data	Estimated Time	Timing
Complete Referral Forms (with script) on New WIC Enrollees	New WIC enrollee	WIC local site staff	2 minutes	Completed
Recruit/Enroll Participants	New WIC enrollee	Westat recruiter	20 minutes	Completed
State Agency Key Informant Interview	Identified by WIC State Agency Director	Altarum	1 hour	Completed
Local Site Visit and Key Informant Interview	Identified by WIC Local Agency Director or Site Supervisor	Altarum	1 hour	Completed
Local WIC Staff Online Survey	All local site WIC staff working directly with participants	Altarum receives and processes data	30 minutes	Completed
WIC Participant Interviews	WIC participants	Westat telephone interviewers	30 minutes	7/13-7/17
WIC Administrative Data (weight, length, food package type)	WIC State Agency data manager or designee	Westat staff receive and abstract	30 minutes	10/14* 10/15 10/16
WIC Administrative Data (weight and height)	WIC State Agency data manager or designee	Westat staff receive and abstract	30 minutes	10/17

*Timing of the WIC administrative data request is based on dates when all infants/children in the study reach the target ages for the measurement data.

Points of Contact

If you have questions or concerns about this letter or your responsibilities in the study, please contact:

For State Agency questions:

Linnea Sallack, Study Coordinator, Altarum Institute [email protected]

(405) 310-4775

For local agency/site questions:

Crystal MacAllum, Operations Director, Westat

[email protected]

(301) 251-4232

The primary contact we have for your State is: [INSERT NAME OF STATE AGENCY POC].

If this changes, please let us know as soon as possible by contacting Carol Normand, Operations Manager at Altarum Institute, at [email protected] or (207) 358-2794.

We will provide a copy of this letter and Attachment A to the local site(s) that are participating in the study.

Again, we are very grateful for your participation in this important study and appreciate all of the assistance provided by your State Agency and the local site(s).

Sincerely,

The Feeding My Baby Study Research Team

Linnea Sallack, Study Coordinator, Altarum Institute

Crystal MacAllum, Operations Director, Westat

cc: [Site #1 Point of Contact]

[Site #2 Point of Contact]

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB number.  The valid OMB control number for this information collection is 0584-0580.  The time required to complete this information collection is estimated to average 2 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.