Recruiting

Observational Study

Sponsor:

University of North Carolina, Greensboro

Code:

NCT06921382

Conditions

Breastfeeding Self-Efficacy

Breastfeeding Continuation

Breastfeeding Duration

Breastfeeding Support

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Peer counseling

Additional funds

Study Details

Brief summary:

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.

Conditions

Breastfeeding Self-Efficacy

Breastfeeding Continuation

Breastfeeding Duration

Breastfeeding Support

Study ID

NCT06921382

Start date

Mar 17, 2025

Status verified date

Aug, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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):

1. Confirmation of Hispanic origin
2. Receives or eligible for WIC
3. Mother is 18 years or older
4. Singleton pregnancy
5. Mother intends to breastfeed.

Inclusion Criteria Set 2 (determined after infants are born):

1. Infant gestational age 37 weeks or more
2. Normal infant birth weight (i.e., > 5 lbs 8 oz.)
3. Breastfeeding has been initiated
4. No congenital or other health issues (such as cleft palate) identified that require specific accommodations for feeding.

Exclusion Criteria:

1. Mothers below 18 years of age.
2. Mothers do not plan to breastfeed.
3. Mothers not eligible to participate in the WIC program due to high household income
4. Non-singleton pregnancy.

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Intervention group (peer counseling and funds)

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.

no intervention: Control group

Participants in the control condition will receive care-as-usual. For example, they will have access to WIC services, which can include peer counseling.

Interventions

Peer counseling

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).

Additional funds

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.

Primary outcome measure

  • Exclusive breastfeeding [ Time Frame: From enrollment to the end of the study at 6 months ]
  • Infant measurements [ Time Frame: From enrollment to the end of the study at 6 months ]

Central Contacts and Locations

Central contacts

Jasmine M DeJesus, PhD

336-256-0052jmdejes2@uncg.edu

Jigna M Dharod, PhD

jmdharod@uncg.edu

Locations

WIC Guilford County

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

Cone Health

Recruiting

Greensboro, North Carolina, United States, 27405

Contacts

More Information

Sponsor

University of North Carolina, Greensboro

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Greensboro on 2025-08-08.