State, Local and/or Tribal Agencies

Appendix C2: Study Enrollment Form

Study Enrollment Form

OMB Clearance Number: 0584-0548 Expiration Date: xx/xx/20xx

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 0584-0548. The time required to complete this information collection is estimated to average 5 minutes per response. If you have any comments concerning the accuracy of time estimates or suggestions for improving this form, please contact: U. S. Department of Agriculture, Food and Nutrition Service, Office of Research & Analysis, Room 1014, Alexandria, VA 22302.

Part One: Eligibility

Instructions to WIC clinic staffperson: After certifying a pregnant woman for WIC benefits, use the following Eligibilty Screener to determine whether or not to discuss the WIC Peer Counseling Study with her. The information below was probably collected as part of WIC certification. Complete as much information as possible from WIC participant’s records. For any missing information, ask the question written in italics.

I’d like to ask you a few questions to see if you are eligible to participate in a study we’re doing about the choices women make about feeding their newborns. If you are eligible, I will tell you all about the study and you can decide whether or not to participate. You don’t have to answer any of these questions if you don’t want to.

1. Has this WIC participant ever given birth to a baby? (Have you ever given birth to a baby?)

 Yes INELIGIBLE, go to A1

 No Go to Question 2a

 DECLINED INELIGIBLE, go to A4

2a. How many weeks or months pregnant is this WIC participant today? (How many weeks or months pregnant are you today?)

 12 weeks or less (3 months or less) ELIGIBLE LATER, go to B1

 13 to 24 weeks (3 to 6 months) Go to Question 2b

 25 to 28 weeks (6 to 7 months) Go to Question 2b

 29 to 32 weeks (7 to 8 months) Go to Question 2b

 33 weeks or more (more than 8 months) INELIGIBLE, go to A2

 DON’T KNOW Go to Question 2b

 DECLINED INELIGIBLE, go to A4

2b. What is this WIC participant’s due date? (What is your baby’s due date?)

Baby’s Due Date:

MONTH DAY YEAR

 DON’T KNOW INELIGIBLE go to A4

3. How old is this WIC Participant? (How old are you?)

• 17 years of age or younger INELIGIBLE, go to A3

• 18 years of age or older INVITE TO PARTICIPATE

• DECLINED INELIGIBLE go to A3

INELIGIBLE

A1. This study is only for women who will be first-time mothers. Since you’ve had a baby before, this study is not appropriate for you.

A2. This study is only for women who are less than 33 weeks pregnant (that is, who are no more than 8 months pregnant).

A3. This study is only for women who are at least 18 years of age.

A4. For this study, women must be willing to provide certain information about themselves and their pregnancy. Women who do not wish to give this information may not participate in the study, but will still receive all agency benefits for which they certify.

ELIGIBLE LATER

B1. This individual might be eligible for the study in a few months. Give her a study brochure. Say: We’re participating in a study about how our breastfeeding peer counseling program affects the choices women make about feeding their infants. You might be eligible for the study in a few months. In the meantime, this brochure tells you about it. We can talk about the study more when you come back for your next visit. You do not have to participate in the study. If you decide not to, you will still receive all of the benefits that you certify for.”

ELIGIBLE NOW: INVITE TO PARTICIPATE by reading the Invitation Script

INVITATION SCRIPT:

Say: We’re participating in a study about how our breastfeeding peer counseling program affects the choices women make about feeding their infants. The purpose of the study is to find out what kind of peer counseling is better for helping women breastfeed their babies. You don’t have to participate in the study if you don’t want to. If you decide not to participate in this study, you can still talk to one of our breastfeeding peer counselors, and you’ll still receive everything we’ve already discussed including food vouchers for you and your baby, nutritional classes/counseling, and all of the other services for which you are eligible. Women who participate in the study will be asked to complete two surveys by telephone. If you complete the first phone survey before you give birth you will receive $20. If you complete the second survey, after you give birth, you will receive another $20. Also, if you call a toll-free number within 2 weeks after your baby’s birth, you will receive a $5 gift card to [NATIONAL RETAIL STORE]. Let me go over this consent document with you before you decide.

• Use the Invitation Tracking Log to log the invitation and the WIC Participant’s decision.

• If the WIC participant signs the Consent Form, complete Part Two: Enrollment Information on the next page.

• If the WIC participant decides not to take part in the study, ask her to complete a Decline Form.

Part Two: Enrollment Information

Today’s Date:

WIC participant’s Name:

First:

Last:

Baby’s Due Date:

Street

Apt #

City

State

ZIP

Phone #1

 cell  home  work

( )

Phone #2

 cell  home  work

( )

Best times to call

Weekdays AM Noon-1 PM Weekends AM Noon-1 PM

Please do not call during these times

Weekdays AM Noon-1 PM Weekends AM Noon-1 PM

Text msgs ok?

YES NO

Cellphone if not Phone #1 or #2

Age:

years

Language (if other than English):

Spanish Chinese Tagalog Vietnamese Other:

Name of alternate contact

Relationship to WIC participant

Relative Friend Co-worker Other

Telephone of alternate

( )

Assigned Peer Counselor #1

Alternate Peer Counselor #2

Name of WIC staffperson completing this form:

Comments (if needed):

(Abt-use only) Study ID number

Abt Associates Inc. Study Enrollment Form