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NCT Number: NCT06921382

Breastfeeding Intervention to Prevent Obesity Among Children

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.

Recruiting

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Key information

Age range

5 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cone Health, Greensboro, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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):

  • Confirmation of Hispanic origin
  • Receives or eligible for WIC
  • Mother is 18 years or older
  • Singleton pregnancy
  • Mother intends to breastfeed.

Inclusion criteria

Set 2 (determined after infants are born):

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

Exclusion criteria

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Exclusive breastfeeding

    Time frame: From enrollment to the end of the study at 6 months

    Weeks of exclusive breastfeeding. Mothers will complete weekly surveys about their feeding experience.

  2. Infant measurements

    Time frame: From enrollment to the end of the study at 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jasmine M DeJesus, PhD

CONTACT

[email protected]

336-256-0052

Jigna M Dharod, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of North Carolina, Greensboro

Other

Collaborators

  • Duke University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 10, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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