Pregnancy RelatediLATCHNCT07560553
Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers
A study testing Breastfeeding Education in people with Pregnancy Related and Breast Feeding, Exclusive, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to increase the rate of exclusive breastfeeding at 6 weeks postpartum in the Inland Empire by addressing inadequate antenatal breastfeeding education for patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Breast Feeding, Exclusive
- What is being tested?
- Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2026to Jun 2028
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous mothers
- Multiparous mothers who did not breastfeed previous children or breastfed previous children for less than 6 months
Who cannot join
- Mothers planning to use formula
- Multiparous mothers who previously breastfed for more than 6 months
- Mothers with HIV
- Mothers with a history of breast reduction surgery
- Infants with major birth defects that may impede growth or feeding, such as cleft lip and/or palate, cardiac defects, and gastrointestinal defects
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University Faculty Medical Offices
Loma Linda, California, 92354-3619
Elaine Hart, M.D., 909-558-2806 ext. 15505, ehart@llu.edu
About this study
Official title: Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers: Randomized Control Trial
The purpose of this study is to increase the rate of exclusive breastfeeding at 6 weeks postpartum in the Inland Empire by addressing inadequate antenatal breastfeeding education for patients.
Read the detailed description
A total of 196 participants will be enrolled and randomized into two groups: an experimental cohort that receives supplemental breastfeeding education during three of their scheduled prenatal visits, and a control group that continues with standard prenatal care alone. Medical students will undergo lactation counselor training to be prepared to visit and educate patients. Both arms of the study will take a pre-survey at the first visit and a post-survey at 6 weeks postpartum to evaluate breastfeeding knowledge, confidence, and motivation. Medical students will also take a survey pre-training and post-study to evaluate growth in breastfeeding education.
- Conditions
- Pregnancy Related, Breast Feeding, Exclusive
- Being tested
- Breastfeeding Education
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding EducationBehavioural
First meeting will include a pre-test and will go over risks, benefits, and goals for breastfeeding for the mother, baby and family. Second meeting will go over barriers to breastfeeding and the difference between formula and breastmilk. Third visit will include a post-test and go over misconceptions of breastfeeding and the optimal frequency to breastfeed their newborn. Appropriate flyers will be administered at each visit. Congratulatory \& supportive text at birth and 6-week follow up survey will also be administered.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding Education | Experimental | Participants receive 3 prenatal breastfeeding education interventions during antenatal visits. 6-week postpartum survey will be administered. Receives: Behavioral: Breastfeeding Education |
| Placebo | No intervention | Participants receive no extra breastfeeding education during antenatal visits. 6-week postpartum survey will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Exclusive Breastfeeding at 6 Weeks Postpartum.
Subjects will complete a Qualtrics survey of 2 questions administered via text message, to determine breastfeeding exclusivity. This survey will be calculated on a Likert scale 0-100. A percentage of 100% will determine exclusive breastfeeding. A percentage of 70-90% represents intermittent breastfeeding. A percentage of less than 70% represents non-exclusive breastfeeding.
Measured: Change between baseline (time of newborn's first feeding) and 6 week post-partum visit.
Secondary outcomes (2)
Breastfeeding education pre and post self-efficacy scores of medical students
Assessment of medical student proficiency in breastfeeding management and patient care will be measured using a 25-item multiple-choice questionnaire. The survey evaluates core competencies before and after a structured educational intervention, including the Institute for the Advancement of Breastfeeding and Lactation Education (IABLE) course and a supplemental PowerPoint presentation given by Dr. Elaine Hart. Each question is worth one point, with total scores ranging from 0 to 25; a higher score indicates an increase in breastfeeding knowledge and management competency.
Measured: Change between baseline through study completion, an average of 1 year.
Maternal Satisfaction with Antenatal Breastfeeding Support and Knowledge, Motivation, and Confidence.
Assessment of maternal satisfaction with antenatal breastfeeding support, knowledge, motivation, and confidence will be measured using a 13-item questionnaire. The instrument utilizes a combination of 5-point Likert scales to assess self-efficacy and motivation, as well as objective multiple-choice questions to evaluate understanding of breastfeeding benefits, infant output, and clinical management. Knowledge-based items are scored with one point for each correct response, while Likert-scale items are recorded by their selected numerical value (1-5). A higher total composite score represents a longitudinal increase in breastfeeding knowledge, confidence, and motivation from baseline (pre-enrollment) to the 6-week postpartum follow-up.
Measured: Change between 1st trimester and 6 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start16 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560553
- Sponsor's protocol ID
- 5260056
- Acronym
- iLATCH
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07560553
- Acronym / sponsor ID
- iLATCH / 5260056
- Conditions
- Pregnancy Related, Breast Feeding, Exclusive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 1 May 2026 (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 purpose of this study is to increase the rate of exclusive breastfeeding at 6 weeks postpartum in the Inland Empire by addressing inadequate antenatal breastfeeding education for patients.
Detailed description
A total of 196 participants will be enrolled and randomized into two groups: an experimental cohort that receives supplemental breastfeeding education during three of their scheduled prenatal visits, and a control group that continues with standard prenatal care alone. Medical students will undergo lactation counselor training to be prepared to visit and educate patients. Both arms of the study will take a pre-survey at the first visit and a post-survey at 6 weeks postpartum to evaluate breastfeeding knowledge, confidence, and motivation. Medical students will also take a survey pre-training and post-study to evaluate growth in breastfeeding education.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Education | Experimental | Behavioral: Breastfeeding EducationParticipants receive 3 prenatal breastfeeding education interventions during antenatal visits. 6-week postpartum survey will be administered. |
| Placebo | No intervention | –Participants receive no extra breastfeeding education during antenatal visits. 6-week postpartum survey will be administered. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nulliparous mothers
- Multiparous mothers who did not breastfeed previous children or breastfed previous children for less than 6 months
Key exclusion criteria (5 listed)
- Mothers planning to use formula
- Multiparous mothers who previously breastfed for more than 6 months
- Mothers with HIV
- Mothers with a history of breast reduction surgery
- Infants with major birth defects that may impede growth or feeding, such as cleft lip and/or palate, cardiac defects, and gastrointestinal defects
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 |
|---|---|---|
| Breastfeeding EducationFirst meeting will include a pre-test and will go over risks, benefits, and goals for breastfeeding for the mother, baby and family. Second meeting will go over barriers to breastfeeding and the difference between formula and breastmilk. Third visit will include a post-test and go over misconceptions of breastfeeding and the optimal frequency to breastfeed their newborn. Appropriate flyers will be administered at each visit. Congratulatory \& supportive text at birth and 6-week follow up survey will also be administered. | Behavioural | Breastfeeding Education |
Primary outcome
Prevalence of Exclusive Breastfeeding at 6 Weeks Postpartum.
Time frame: Change between baseline (time of newborn's first feeding) and 6 week post-partum visit.
Subjects will complete a Qualtrics survey of 2 questions administered via text message, to determine breastfeeding exclusivity. This survey will be calculated on a Likert scale 0-100. A percentage of 100% will determine exclusive breastfeeding. A percentage of 70-90% represents intermittent breastfeeding. A percentage of less than 70% represents non-exclusive breastfeeding.
2 secondary outcomes
Breastfeeding education pre and post self-efficacy scores of medical students
Time frame: Change between baseline through study completion, an average of 1 year.
Maternal Satisfaction with Antenatal Breastfeeding Support and Knowledge, Motivation, and Confidence.
Time frame: Change between 1st trimester and 6 weeks postpartum.
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 23 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Education in people with Pregnancy Related and Breast Feeding, Exclusive, run by Loma Linda University at 1 site 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 2 inclusion and 5 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Elaine Hart, M.D. ((909) 558-2806 ext. 15505, ehart@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Exclusive Breastfeeding at 6 Weeks Postpartum. (time frame: Change between baseline (time of newborn's first feeding) and 6 week post-partum visit.). 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 23 Jun 2026.