Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers (iLATCH)

April 27, 2026 updated by: Loma Linda University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elaine Hart, M.D.
  • Phone Number: 15505 (909) 558-2806
  • Email: ehart@llu.edu

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354-3619
        • Loma Linda University Faculty Medical Offices
        • Contact:
          • Elaine Hart, M.D.
          • Phone Number: 15505 909-558-2806
          • Email: ehart@llu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Nulliparous mothers
  • Multiparous mothers who did not breastfeed previous children or breastfed previous children for less than 6 months

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breastfeeding Education
Participants receive 3 prenatal breastfeeding education interventions during antenatal visits. 6-week postpartum survey will be administered.
Behavioral: Breastfeeding Education
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.
No Intervention: Placebo
Participants receive no extra breastfeeding education during antenatal visits. 6-week postpartum survey will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change between baseline (time of newborn's first feeding) and 6 week post-partum visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding education pre and post self-efficacy scores of medical students
Time Frame: Change between baseline through study completion, an average of 1 year.
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.
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.
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.
Change between 1st trimester and 6 weeks postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 27, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5260056

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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