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Clinical Trials/NCT06127914
NCT06127914
Not Yet Recruiting
N/A

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

Florida State University0 sites39 target enrollmentJuly 1, 2027

Overview

Phase
N/A
Intervention
Learning Early Infant Feeding Cues
Conditions
Responsive Feeding
Sponsor
Florida State University
Enrollment
39
Primary Endpoint
Responsive Feeding
Status
Not Yet Recruiting
Last Updated
5 days ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
July 1, 2027
End Date
June 30, 2029
Last Updated
5 days ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica Bahorski

Assistant Professor

Florida State University

Eligibility Criteria

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

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)

Arms & Interventions

LEIFc Intervention

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

Intervention: Learning Early Infant Feeding Cues

Outcomes

Primary Outcomes

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

  • 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)

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