Learning Early Infant Feeding Cues

NCT06127914 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00004685
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Responsive Feeding

  Subjective (via survey) and objective (via video) measurement of responsive feeding will be collected. Participants will complete the Infant Feeding Questionnaire to provide a subjective measure of responsive feeding. A feeding session will be video recording then coded for instances of infant cues and maternal response to cues to provide an objective measure of responsive feeding.

  Pre (infant age of 2 weeks) and post (infant age of 6 weeks) intervention.

Secondary Outcomes (3)

• Infant growth trajectory

  Infant age of 2 weeks to 6 months.

• Age of complementary food introduction

  weeks or months since birth

• Duration of any breastfeeding

  weeks or months since birth

Study Arms (1)

LEIFc Intervention

EXPERIMENTAL

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

Behavioral: Learning Early Infant Feeding Cues

Interventions

Learning Early Infant Feeding Cues 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.

LEIFc Intervention

Eligibility Criteria

• Age: 2 Weeks+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• Florida State University: lead

Related Publications (1)

• 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.

  PMID: 36853761 BACKGROUND

MeSH Terms

Conditions

Body-Weight Trajectory

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jessica Bahorski

CONTACT

8506446013; jbahorski@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04