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NCT Number: NCT06127914

Learning Early Infant Feeding Cues

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.

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Key information

Conditions

Responsive Feeding Body Weight Body Weight Changes Body-Weight Trajectory Infants Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain Trajectory

Age range

2 week and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Responsive Feeding

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

    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.

Secondary outcomes

  1. Infant growth trajectory

    Time frame: Infant age of 2 weeks to 6 months.

    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.

  2. Age of complementary food introduction

    Time frame: weeks or months since birth

    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.

  3. Duration of any breastfeeding

    Time frame: weeks or months since birth

    Current infant feeding practices are collected at each study visit. Duration of any breastfeeding will be tabulated into a variable.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Bahorski

CONTACT

[email protected]

8506446013

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Acronym: LEIFc

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Nov 13, 2023
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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