Breastfeeding Intervention to Prevent Obesity Among Children (SMile)

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 Overview

• Status: Recruiting
• Conditions: Breastfeeding Support; Breastfeeding Duration; Breastfeeding Continuation; Breastfeeding Self-Efficacy
• Intervention / Treatment: Behavioral: Peer counseling; Behavioral: Additional funds

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jasmine M DeJesus, PhD; Phone Number: 336-256-0052; Email: jmdejes2@uncg.edu
• Study Contact Backup: Name: Jigna M Dharod, PhD; Email: jmdharod@uncg.edu

Study Locations

• United States
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Recruiting
      • WIC Guilford County
      • Contact: Erin Cashwell; Phone Number: 336-641-6597; Email: ecashwe@guilfordcountync.gov
    • Greensboro, North Carolina, United States, 27405
      • Recruiting
      • Cone Health
      • Contact: Marjorie Jenkins; Phone Number: 336-663-5512; Email: MARJORIE.JENKINS@conehealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (peer counseling and funds); 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.	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.
No Intervention: Control group; Participants in the control condition will receive care-as-usual. For example, they will have access to WIC services, which can include peer counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Greensboro
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Duke University
• Investigators: 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

Publications and helpful links

Helpful Links

• Description on NIH reporter

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: IRB-FY24-392; R01DK140892 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is critical to reassure participants that the investigators will not share their personal information, so it might not be possible to share individual participant data, even if it is de-identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No