Breastfeeding Intervention to Prevent Obesity Among Children

Not Applicable

Recruiting

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

• Registration Number: NCT06921382
• Lead Sponsor: University of North Carolina, Greensboro

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-26
• Study Start: 2025-03-17
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-10
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-08
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Exclusive breastfeeding	From enrollment to the end of the study at 6 months	Weeks of exclusive breastfeeding. Mothers will complete weekly surveys about their feeding experience.
Infant measurements	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.

Trial Locations

Locations (2)

WIC Guilford County; 🇺🇸 Greensboro, North Carolina, United States

Cone Health; 🇺🇸 Greensboro, North Carolina, United States