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Learning Early Infant Feeding Cues

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06127914
Acronym
LEIFc
Enrollment
39
Registered
2023-11-13
Start date
2027-07-01
Completion date
2029-06-30
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infants, Responsive Feeding, Weight Gain Trajectory

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.

Interventions

BEHAVIORALLearning 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.

Sponsors

Florida State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
2 Weeks to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Responsive FeedingPre (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

MeasureTime frameDescription
Infant growth trajectoryInfant 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.
Age of complementary food introductionweeks or months since birthCurrent 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.
Duration of any breastfeedingweeks or months since birthCurrent infant feeding practices are collected at each study visit. Duration of any breastfeeding will be tabulated into a variable.

Contacts

CONTACTJessica Bahorski
jbahorski@fsu.edu8506446013

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026