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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK140892 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Duke University | OTHER |
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The goal of this clinical trial is to learn how to improve exclusive breastfeeding rates. The main questions it aims to answer are:
Do Hispanic mothers benefit from peer counseling support from peer counselors who can speak Spanish? Are mothers more likely to continue exclusive breastfeeding if additional funds are given so that the WIC exclusive breastfeeding package has the same cash value as the WIC formula feeding package?
Researchers will compare participants in the intervention group (who receive peer counseling and additional funds) to a control group (who do not receive peer counseling or additional funds) to see if the intervention package improves breastfeeding rates.
All participants (intervention and control) will complete weekly surveys about their feeding experiences ($8 per week). Members of the research team will also take infant weight/length measurements at home (twice during the first month and then at 2, 4, and 6 months). Participants will be recruited during pregnancy and the study will last for the first 6 months after their babies are born. Mothers and their infants are both participants in the study.
Participants in the intervention condition will also be matched with Spanish-speaking peer counselors who will visit mothers at home regularly (weekly at the beginning of the study, monthly at the end of the study). In Month 1, mothers can choose to receive a $150 gift card or an electric breast pump. In Months 2-5, if infants are signed up for the WIC exclusive breastfeeding package, infants will receive $100 and mothers will receive $50. If infants are signed up for the WIC partial breastfeeding package, infants will receive $50 and mothers will receive $30.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group (peer counseling and funds) | Experimental | Participants in the intervention condition will be matched with Spanish-speaking peer counselors who will visit mothers at home regularly (weekly at the beginning of the study, monthly at the end of the study). In Month 1, mothers can choose to receive a $150 gift card or an electric breast pump. In Months 2-5, if infants are signed up for the WIC exclusive breastfeeding package, infants will receive $100 and mothers will receive $50. If infants are signed up for the WIC partial breastfeeding package, infants will receive $50 and mothers will receive $30. |
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| Control group | No Intervention | Participants in the control condition will receive care-as-usual. For example, they will have access to WIC services, which can include peer counseling. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer counseling | Behavioral | Participants in the intervention condition will be matched with Spanish-speaking peer counselors who will visit mothers at home regularly (weekly at the beginning of the study, monthly at the end of the study). |
| Measure | Description | Time Frame |
|---|---|---|
| Exclusive breastfeeding | Weeks of exclusive breastfeeding. Mothers will complete weekly surveys about their feeding experience. | From enrollment to the end of the study at 6 months |
| Infant measurements | A member of the research team will take infant weight and length measurements at participants' homes. Measurements will be taken twice during the first month and then at the end of months 2, 4, and 6. Measurements will be converted into weight-for-age z-scores according to the World Health Organization Child Growth Standards (birth to 24 months). Scores typically range from about -6 to +6, with higher scores indicating greater length relative to age. A score of 0 represents the median for the reference population. | From enrollment to the end of the study at 6 months |
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Mothers and infants are both participants in the study. By the time study activities start, infants will be around 5 days old.
Inclusion Criteria Set 1 (determined at prenatal recruitment):
Inclusion Criteria Set 2 (determined after infants are born):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasmine M DeJesus, PhD | Contact | 336-256-0052 | jmdejes2@uncg.edu | |
| Jigna M Dharod, PhD | Contact | jmdharod@uncg.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jasmine M DeJesus, PhD | UNC Greensboro | Principal Investigator |
| Jigna M Dharod, PhD | UNC Greensboro | Principal Investigator |
| Aunchalee E. L. Palmquist, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WIC Guilford County | Recruiting | Greensboro | North Carolina | 27401 | United States |
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| Label | URL |
|---|---|
| Description on NIH reporter | View source |
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It is critical to reassure participants that the investigators will not share their personal information, so it might not be possible to share individual participant data, even if it is de-identified.
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| Additional funds | Behavioral | In Month 1, mothers can choose to receive a $150 gift card or an electric breast pump. In Months 2-5, if infants are signed up for the WIC exclusive breastfeeding package, infants will receive $100 and mothers will receive $50. If infants are signed up for the WIC partial breastfeeding package, infants will receive $50 and mothers will receive $30. |
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| Duke University |
| Principal Investigator |
| Cone Health | Recruiting | Greensboro | North Carolina | 27405 | United States |
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