Breastfeeding Intervention to Prevent Obesity Among Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peer counseling, Additional funds.
- Who it may be relevant to
- Registry conditions: Breastfeeding Self-Efficacy, Breastfeeding Continuation, Breastfeeding Duration, Breastfeeding Support. Basic parameters: from 5 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Peer 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). - Behavioral Additional 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.
Primary outcome measures
- Exclusive breastfeeding [Time frame: From enrollment to the end of the study at 6 months]
- Infant measurements [Time frame: From enrollment to the end of the study at 6 months]
Eligibility 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):
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- WIC Guilford County — Greensboro
- Cone Health — Greensboro
Identifiers
NCT: NCT06921382 · IRB-FY24-392 · R01DK140892