Learning Early Infant Feeding Cues

NCT ID: NCT06127914

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-06-30

Brief Summary

The goal of this clinical trial is to learn more about responsive infant feeding (recognizing baby's signs of hunger and fullness) in mothers and infant enrolled in government-funded maternal-child home visiting programs. The main questions it aims to answer are:

• What are the contributors and barriers to use of responsive infant feeding?
• How can we refine an intervention focused on responsive infant feeding (the Learning Early Infant Feeding Cues intervention) so that mothers will like it and learn skills to help their baby be healthy.
• Will the refined intervention improve use of responsive feeding and be feasible and acceptable to mothers and home visiting programs?

Participants will be asked to:

• Participate in focus groups to talk about their experiences feeding their baby.
• Participate in a study to learn about responsive feeding and how to use it with their baby. This study will start when mothers are in their final month of pregnancy and finish when their baby is 6 months old. Participation will include:

• Having someone come to the family home during a time when the baby is eating (either from the breast or the bottle). The mother will receive information on the baby's signs from an experienced coach.
• Agreeing to be video recording during the session when the baby is eating.
• Completing surveys online.

Conditions

Responsive Feeding; Infants; Weight Gain Trajectory

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

LEIFc Intervention

There is only 1 arm of this study. All participants will receive the LEIFc intervention.

Group Type: EXPERIMENTAL

Learning Early Infant Feeding Cues

Intervention Type: BEHAVIORAL

The LEIFc intervention includes individualized responsive feeding education and promotion using the SS-OO-PP-RR (or "super," Setting the Stage, Observation and Opportunities to Embed, Problem Solving and Planning, Reflection and Review coaching approach as a guide. An interventionists interacts with mother-infant dyads during a feeding session at infant ages of 1, 2, 3, 4, and 5 months and coaches the mother on responsive feeding. In particular infant cues of hunger and fullness and tips to assist the mother in making decisions regarding feeding her infant. This will begin with milk based feedings (either breastmilk from breast or bottle, or formula from a bottle), and continue through the transition to solid (complementary) foods.

Interventions

Learning Early Infant Feeding Cues

The LEIFc intervention includes individualized responsive feeding education and promotion using the SS-OO-PP-RR (or "super," Setting the Stage, Observation and Opportunities to Embed, Problem Solving and Planning, Reflection and Review coaching approach as a guide. An interventionists interacts with mother-infant dyads during a feeding session at infant ages of 1, 2, 3, 4, and 5 months and coaches the mother on responsive feeding. In particular infant cues of hunger and fullness and tips to assist the mother in making decisions regarding feeding her infant. This will begin with milk based feedings (either breastmilk from breast or bottle, or formula from a bottle), and continue through the transition to solid (complementary) foods.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pregnant mother in the 3rd trimester (28 weeks or beyond)
• Enrolled in a government-funded maternal-child home visiting program
• Maternal age 18 years or older
• English or Spanish speaking
• Anticipated to have custody of infant after birth
• Healthy pregnancy, no complications that are anticipated to result in a preterm birth or extended hospital stay for mother or infant

• Born as a singleton (not a twin, triplet, etc.) to a mother enrolled in a maternal-child home visiting program
• Born full term (37 weeks or beyond)

Exclusion Criteria

• Gave birth to multiple fetuses
• Age less than 18 years
• Not fluent in English or Spanish
• Expected to not have custody of the infant after birth

• Congenital anomaly that may interfere with infant feeding or growth after birth (i.e., Down Syndrome, cleft lip/palate)
• Born preterm (born prior to 37 weeks)
• NICU stay beyond 48 hours
• Infant diagnosis of failure to thrive
• Supplemental oxygen
• Enteral feeding device used for feedings

• Minimum Eligible Age: 2 Weeks
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Jessica Bahorski

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jessica Bahorski

Role: CONTACT

jbahorski@fsu.edu

8506446013

References

Bahorski J, Romano M, McDougal JM, Kiratzis E, Pocchio K, Paek I. Development of an Individualized Responsive Feeding Intervention-Learning Early Infant Feeding Cues: Protocol for a Nonrandomized Study. JMIR Res Protoc. 2023 Feb 28;12:e44329. doi: 10.2196/44329.

Reference Type: BACKGROUND

PMID: 36853761 (View on PubMed)

Other Identifiers

STUDY00004685

Identifier Type: -

Identifier Source: org_study_id