Breastfeeding Self-EfficacyNCT06921382
Breastfeeding Intervention to Prevent Obesity Among Children
A study testing Peer counseling and Additional funds in people with Breastfeeding Self-Efficacy and Breastfeeding Continuation, run by University of North Carolina, Greensboro at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 days and olderHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Self-Efficacy, Breastfeeding Continuation, Breastfeeding Duration
- What is being tested?
- Peer counseling and Additional funds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Mar 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jigna M Dharod, PhD contact
United States2 sites, 2 recruiting
- Recruiting
WIC Guilford County
Greensboro, North Carolina, 27401
Erin Cashwell, 336-641-6597, ecashwe@guilfordcountync.gov
- Recruiting
Cone Health
Greensboro, North Carolina, 27405
Marjorie Jenkins, 336-663-5512, MARJORIE.JENKINS@conehealth.com
About this study
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?
Read more
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.
- Conditions
- Breastfeeding Self-Efficacy, Breastfeeding Continuation, Breastfeeding Duration, Breastfeeding Support
- Being tested
- Peer counseling, Additional funds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer counselingBehavioural
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 fundsBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention group (peer counseling and funds) | Experimental | 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. Receives: Behavioral: Peer counseling; Behavioral: Additional funds |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding
Weeks of exclusive breastfeeding. Mothers will complete weekly surveys about their feeding experience.
Measured: 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.
Measured: From enrollment to the end of the study at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start17 Mar 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding Self-EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Duke University
- Responsible party
- Sponsor
- Investigators
- Jasmine M DeJesus, PhD, Principal investigator, UNC GreensboroJigna M Dharod, PhD, Principal investigator, UNC GreensboroAunchalee E. L. Palmquist, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921382
- Sponsor's protocol ID
- IRB-FY24-392
- Other IDs
- R01DK140892
- Status last verified
- Aug 2025
- First submitted
- 26 Feb 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding Intervention to Prevent Obesity Among Children
- ClinicalTrials.gov ID
- NCT06921382
- Acronym / sponsor ID
- IRB-FY24-392
- Conditions
- Breastfeeding Self-Efficacy, Breastfeeding Continuation, Breastfeeding Duration, Breastfeeding Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Duke University
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (peer counseling and funds) | Experimental | Behavioral: Peer counseling, Behavioral: Additional fundsParticipants 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 intervention | –Participants in the control condition will receive care-as-usual. For example, they will have access to WIC services, which can include peer counseling. |
Who may qualify
- Ages
- 5 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer counselingParticipants 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). | Behavioural | Intervention group (peer counseling and funds) |
| Additional fundsIn 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. | Behavioural | Intervention group (peer counseling and funds) |
Primary outcome
Exclusive breastfeeding
Time frame: From enrollment to the end of the study at 6 months
Weeks of exclusive breastfeeding. Mothers will complete weekly surveys about their feeding experience.
Infant measurements
Time frame: From enrollment to the end of the study at 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Description on NIH reporterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Breastfeeding Self-Efficacy
Not yet recruiting
Effect of a Breastfeeding Chatbot on Mothers' Breastfeeding Attitudes, Behaviors, and Self-Efficacy
Breastfeeding, Breastfeeding Attitudes
Recruiting
Effect of Solution-Focused Approach Education on Breastfeeding Avoidance and Breastfeeding Self-Efficacy in Primiparous Mothers
Breastfeeding Avoidance and Breastfeeding Self-efficacy
Not yet recruiting
HEARTBEAT SOUND FOR BREASTFEEDİNG DİFFİCULTİES: A RANDOMİZED CONTROLLED TRİAL
Sleep, Circadian Rhythm
Not yet recruiting
The Effect of Model-based Education on Breastfeeding Self-efficacy and Success
Breastfeeding
Not yet recruiting
Supportive Care During Childbirth in Syrian Migrant Women
Childbirth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jigna M Dharod, PhD contact
Jasmine M DeJesus, PhD principal investigator
UNC Greensboro
Jigna M Dharod, PhD principal investigator
UNC Greensboro
Aunchalee E. L. Palmquist, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer counseling and Additional funds in people with Breastfeeding Self-Efficacy and Breastfeeding Continuation, run by University of North Carolina, Greensboro at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasmine M DeJesus, PhD (336-256-0052, jmdejes2@uncg.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding (time frame: From enrollment to the end of the study at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.