LEIFc: Learning Early Infant Feeding Cues

Sponsor
Florida State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06127914
Collaborator
(none)
10
1
35.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Learning Early Infant Feeding Cues
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Multiphase Project to Improve Use of Responsive Feeding Among Vulnerable Mother-Infant Dyads
Anticipated Study Start Date :
Jul 1, 2024
Anticipated Primary Completion Date :
Jun 30, 2027
Anticipated Study Completion Date :
Jun 30, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Responsive Feeding [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 Outcome Measures

  1. Infant growth trajectory [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Weeks to 34 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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 18-34 years

  • 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 or greater than 34 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Florida State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jessica Bahorski, Assistant Professor, Florida State University
ClinicalTrials.gov Identifier:
NCT06127914
Other Study ID Numbers:
  • STUDY00004685
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023