App_Q1.Study extension summary and agreement_Correspondence to State Agency with copy to site POC

OMB Approval No.: 0584-0580

Approval Expires: XX/XX/20XX

Appendix Q1

Study Extension Summary and Agreement -

Correspondence to State Agency with Copy to Site POC

Date

Name

Title

Address

City, State, Zip

Dear [Name of State agency Director]:

Thank you for your ongoing participation in the WIC Infant and Toddler Feeding Practices Study-2, called “Feeding My Baby – A National WIC Study.” We appreciate the cooperation and assistance from you, your staff, and the local WIC sites in the implementation of the study. The purpose of this letter is to provide information about the extension of the study. This letter and the attachment(s) are an addendum to previous letters regarding the study.

Study Background and Update

The Feeding My Baby study is being conducted by Westat under contract to the U.S. Department of Agriculture, Food and Nutrition Service (FNS). Westat partners when the study started included Altarum, Public Health Foundation Enterprises, Inc. and the University of California Nutrition Policy Institute. The goals of the current study are to document the feeding practices of WIC infants, toddlers and children through age six, and to assess WIC’s impact on those practices. Recruitment of the infants for the study occurred in 80 WIC sites nationwide in 2013. With assistance from State and local agencies and the sites, a total of 4,367 infants were enrolled in the study.

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]

Since 2013, parents/caregivers of the infants enrolled in the study have participated in multiple phone interviews regarding infant and child feeding practices, dietary intake and other behaviors, and weight and length/height measurements have been collected periodically. The study has produced reports of findings which can be found on the FNS website at https://www.fns.usda.gov/data-research?f%5B0%5D=%3A&f%5B1%5D=program%3A32

Westat is staying in close contact with the parents/caregivers to keep them engaged in the study and participating in the interviews. To date, the retention of children in the study is meeting our expectations. When Westat Study Liaisons have a hard time contacting a parent/caregiver, they occasionally ask staff in the WIC sites or State agencies for assistance. We very much appreciate the help provided in response to these requests. Westat has also made requests to State agencies for specific WIC administrative data for children enrolled in the study and has asked sites to weigh and measure children in the study who are no longer WIC participants. Thank you for responding to these requests and providing critical data for the study.

Study Extension to Age Nine

FNS is extending the study for one additional year, to collect data when the study children are 9 years old. The parents/caregivers will be asked to complete a phone interview when the children are age nine, and weight and height measurements will be collected around that time. This extension will collect additional data regarding feeding practices, dietary intake, and other characteristics as the children mature, and it provides an opportunity to study the impact of WIC participation beyond the period of eligibility. Additionally, the study will also examine WIC administrative data to gather information on former WIC ITFPS-2 participants who left the study before the child’s fifth birthday. This activity will allow FNS to explore if participants who were lost to the study are systematically different from those who continued in the study. It will also allow FNS to determine if these study participants left WIC at the same rate as their counterparts who remained in the study. With this extension, the study will end in September 2025.

Implementation of Study Extension

To extend the study, Westat will contact the parents/caregivers of the children, explain that the study is conducting one more follow up around the child’s ninth birthday, and ask them to continue participating through that date. They will receive an informational letter with details regarding the additional phone interview and an explanation of the incentive amount they will receive for completing it. Westat Study Liaisons will continue to stay in contact with the parents/caregivers to encourage ongoing participation in the study, and they will assist them with obtaining weight and height measurements near the time of the ninth birthday. To obtain the measurements, Westat will provide the parents/caregivers with a Feeding My Baby Study Measurement Card and ask the parent/caregiver to take the child to a WIC site or to a healthcare provider to obtain the measurements and complete the measurement card. When parents/caregivers return the completed measurement card, Westat will provide a $70 gift card plus $10 transportation cost reimbursement (included in the gift card).

State Agency and WIC Site Assistance

During the study extension period, your State Agency will:

• Review your records for administrative data on the participants who left the study in the first five years, and provide the results to Westat. [If State Agency is able to accept a grant, Westat will provide a monetary grant in the amount of $1,000 as a token of our appreciation for the agency’s efforts to retrieve the data].

• Assist Westat with identifying a WIC site where parents/caregivers can take their children to obtain height and weight measurements if the site where they were enrolled in the study is no longer operational or convenient for them. This assistance will be provided by [insert description of what State agency agrees to do, e.g. a designated point-of-contact at the State agency to assist the Westat Study Liaison in identifying a WIC site in the vicinity of the parent/caregiver; providing Westat with information about WIC site locations or a way to access current information about WIC sites].

• [If State agency chooses to be contacted: Occasionally provide Westat Study Liaisons with assistance in contacting parents/caregivers of children in the study who are enrolled in WIC when they cannot be located through other means.]

During the study extension period, the WIC sites in the study will:

• Conduct weight and height measurements for children in the study whose parents/caregivers choose to come to WIC for measurements, and record the measurements on a Feeding My Baby Study Measurement Card.

• [If State agency chooses to have sites contacted: Occasionally provide Westat Study Liaisons with assistance in contacting parents/caregivers of children in the study when they cannot be located through other means.]

The collection of height and weight measurements for study participants who are no longer on WIC is an authorized use of Nutrition Services and Administration funds under Federal regulations at 7 CFR 246.26(k), which require State and local agencies to cooperate in studies and evaluations conducted by or on behalf of the FNS. [Insert when State agency agrees: However, Westat will offer small grants to the study sites for their assistance in weighing and measuring the children who are no longer on WIC. The grants are available only for the 80 designated study sites.]

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 IRBs that have previously approved the study.

Points of Contact

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

Bibi Gollapudi, Deputy Project Director, Westat

BibiGollapudi@westat.com

240-314-7558

The Study 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 Bibi Gollapudi.

We will provide a copy of this letter and Attachment A with information relevant to each site to the Study Contacts at the site(s) that are participating in the study.

Again, we are very grateful for your participation in the Feeding My Baby Study and appreciate all of the assistance provided by your State Agency and the local site(s).

Sincerely,

The Feeding My Baby Study Team

cc: [Site #1]

[Site #2]

The Food and Nutrition Service (FNS) is collecting this information to investigate (1) the dietary practices and the health and nutritional status of the WIC ITFPS-2 children during the ninth year of life; (2) if participants who left the study were systematically different than those who continued in the study and if these study participants left WIC at the same rate as their counterparts who remained in the study. This is a voluntary collection and FNS will use the information to inform WIC service delivery. The collection does request personally identifiable information under the Privacy Act of 1974. Responses will be kept private to the extent provided by law and FNS regulations. 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 0584-0580. The time required to complete this information collection is estimated to average 0.1837 hours (11 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 aspect of this collection of information, including suggestions for reducing this burden, to: U.S. Department of Agriculture, Food and Nutrition Service, Office of Policy Support, 1320 Braddock Place, 5th Floor, Alexandria, VA 22314. ATTN: PRA (0584-0580). Do not return the completed form to this address.

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