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Breastfeeding Intervention to Prevent Obesity Among Children

Breastfeeding Intervention to Prevent Obesity Among Children

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06921382
Enrollment
170
Registered
2025-04-10
Start date
2025-03-17
Completion date
2027-06-30
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding Continuation, Breastfeeding Duration, Breastfeeding Self-Efficacy, Breastfeeding Support

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.

Interventions

BEHAVIORALPeer 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).

BEHAVIORALAdditional 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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Duke University
CollaboratorOTHER
University of North Carolina, Greensboro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Days to No maximum
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Exclusive breastfeedingFrom enrollment to the end of the study at 6 monthsWeeks of exclusive breastfeeding. Mothers will complete weekly surveys about their feeding experience.
Infant measurementsFrom enrollment to the end of the study at 6 monthsA 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.

Countries

United States

Contacts

Primary ContactJasmine M DeJesus, PhD
jmdejes2@uncg.edu336-256-0052
Backup ContactJigna M Dharod, PhD
jmdharod@uncg.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026