Learning Early Infant Feeding Cues (LEIFc)

A Multiphase Project to Improve Use of Responsive Feeding Among Vulnerable Mother-Infant Dyads

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infants; Weight Gain Trajectory; Responsive Feeding
• Intervention / Treatment: Behavioral: Learning Early Infant Feeding Cues

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Bahorski; Phone Number: 8506446013; Email: jbahorski@fsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Maternal 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

Maternal 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

Infant inclusion criteria

• 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)

Infant exclusion criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant growth trajectory	Infant weight-for-length z-score (WLz) will be calculated from infant weight and length measurements obtained at each study visit. The difference in WLz between infant age of 2 weeks and 6 months will be calculated. Infants will be categorized into 3 growth categories: expected growth (WLz SD change between -0.67 and 0.67, rapid growth > or equal to 0.67, or slow growth < or equal to -0.67.	Infant age of 2 weeks to 6 months.
Age of complementary food introduction	Current infant feeding practices are collected at each study visit. The infant age (in weeks) at which any foods other than breastmilk or formula were given will be tabulated into a variable.	weeks or months since birth
Duration of any breastfeeding	Current infant feeding practices are collected at each study visit. Duration of any breastfeeding will be tabulated into a variable.	weeks or months since birth

Collaborators and Investigators

• Sponsor: Florida State University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body-Weight Trajectory
• Other Study ID Numbers: STUDY00004685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Aggregated dataset of deidentified participant data will be shared with other research. A data use agreement (DUA) will be required. Video data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No