Breastfeeding Intervention to Prevent Obesity Among Children

University of North Carolina, Greensboro170 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

170

Interventions

Peer counselingBEHAVIORAL

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 fundsBEHAVIORAL

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

Sex: ALLMin age: 5 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Exclusive breastfeeding

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

Time frame: 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.