Breastfeeding Intervention to Prevent Obesity Among Children

University of North Carolina, Greensboro

Status: Enrolling

Conditions: Breastfeeding Continuation; Breastfeeding Duration; Breastfeeding Support; Breastfeeding Self-Efficacy

Treatments: Behavioral: Peer counseling; Behavioral: Additional funds

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06921382

R01DK140892 (U.S. NIH Grant/Contract)

IRB-FY24-392

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 5+ days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Intervention group (peer counseling and funds)

Experimental group

Description:

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.

Treatment:

Behavioral: Additional funds

Behavioral: Peer counseling

Control group

No Intervention group

Description:

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