Clinical trial NCT06921382: Breastfeeding Peer Counseling Intervention for Latine Families
Official title: Breastfeeding Intervention to Prevent Obesity Among Latine Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding Self-Efficacy
Breastfeeding Continuation
Breastfeeding Duration
Breastfeeding Support
Lead sponsor: University of North Carolina, Greensboro
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Duke University
First posted: 2025-04-10
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn how to improve exclusive breastfeeding rates in the Latine community. Breastfeeding initiation is high in this community, but many people ultimately do not breastfeed for as long as they would like to. The main questions it aims to answer are:

Do Latine mothers benefit from peer counseling support from peer counselors who can speak Spanish and share their cultural background? 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.

Participants in the intervention condition will also be matched with Spanish-speaking Latine peer counselors who will visit mothers at home regularly (weekly at the beginning of the study, monthly at the end of the study) and receive $150 for every month they select the WIC exclusive breastfeeding package. Mothers can choose to receive an electric breast pump instead of one $150 payment.


Eligibility criteria: Inclusion Criteria Set 1 (determined at prenatal recruitment):

1. Confirmation of Latine origin
2. Receives or eligible for WIC
3. 18 years or older
4. Singleton pregnancy
5. intend 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.

Primary outcomes:
measure: Exclusive breastfeeding
timeFrame: From enrollment to the end of the study at 6 months
measure: Infant measurements
timeFrame: From enrollment to the end of the study at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: WIC Guilford County
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health
state: North Carolina
Study officials:
affiliation: UNC Greensboro
name: Jasmine M DeJesus, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Greensboro
name: Jigna M Dharod, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Aunchalee E. L. Palmquist, PhD
role: PRINCIPAL_INVESTIGATOR
References: