NCT07560553

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Apr 2028

Study Start

First participant enrolled

April 1, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 21, 2026

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Change between baseline through study completion, an average of 1 year.

  • Maternal Satisfaction with Antenatal Breastfeeding Support and Knowledge, Motivation, and Confidence.

    Change between 1st trimester and 6 weeks postpartum.

Study Arms (2)

Breastfeeding Education

EXPERIMENTAL

Participants receive 3 prenatal breastfeeding education interventions during antenatal visits. 6-week postpartum survey will be administered.

Behavioral: Breastfeeding Education

Placebo

NO INTERVENTION

Participants receive no extra breastfeeding education during antenatal visits. 6-week postpartum survey will be administered.

Interventions

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.

Breastfeeding Education

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Faculty Medical Offices

Loma Linda, California, 92354-3619, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Central Study Contacts

Elaine Hart, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 1, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations