Breastfeeding Intervention to Prevent Obesity Among Children

NCT ID: NCT06921382

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breastfeeding Self-Efficacy Breastfeeding Continuation Breastfeeding Duration Breastfeeding Support

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Peer counseling

Intervention Type BEHAVIORAL

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 funds

Intervention Type BEHAVIORAL

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

Participants in the control condition will receive care-as-usual. For example, they will have access to WIC services, which can include peer counseling.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.


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.
Minimum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

University of North Carolina, Greensboro

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jasmine M DeJesus, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Greensboro

Jigna M Dharod, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Greensboro

Aunchalee E. L. Palmquist, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

WIC Guilford County

Greensboro, North Carolina, United States

Site Status RECRUITING

Cone Health

Greensboro, North Carolina, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jasmine M DeJesus, PhD

Role: CONTACT

336-256-0052

Jigna M Dharod, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Erin Cashwell

Role: primary

336-641-6597

Marjorie Jenkins

Role: primary

336-663-5512

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DK140892

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-FY24-392

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Breastfeeding - a Good Start Together
NCT05311631 ACTIVE_NOT_RECRUITING NA