Breastfeeding Intervention to Prevent Obesity Among Children
2 other identifiers
interventional
170
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2025
CompletedStudy Start
First participant enrolled
March 17, 2025
CompletedFirst Posted
Study publicly available on registry
April 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
August 8, 2025
August 1, 2025
2.3 years
February 26, 2025
August 4, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Exclusive breastfeeding
Weeks of exclusive breastfeeding. Mothers will complete weekly surveys about their feeding experience.
From enrollment to the end of the study at 6 months
Infant measurements
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.
From enrollment to the end of the study at 6 months
Study Arms (2)
Intervention group (peer counseling and funds)
EXPERIMENTALParticipants 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.
Control group
NO INTERVENTIONParticipants in the control condition will receive care-as-usual. For example, they will have access to WIC services, which can include peer counseling.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Confirmation of Hispanic origin
- Receives or eligible for WIC
- Mother is 18 years or older
- Singleton pregnancy
- Mother intends to breastfeed.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
WIC Guilford County
Greensboro, North Carolina, 27401, United States
Cone Health
Greensboro, North Carolina, 27405, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Jasmine M DeJesus, PhD
UNC Greensboro
- PRINCIPAL INVESTIGATOR
Jigna M Dharod, PhD
UNC Greensboro
- PRINCIPAL INVESTIGATOR
Aunchalee E. L. Palmquist, PhD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2025
First Posted
April 10, 2025
Study Start
March 17, 2025
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
August 8, 2025
Record last verified: 2025-08