Learning Early Infant Feeding Cues

Not Applicable

Not yet recruiting

• Conditions: Infants; Responsive Feeding; Weight Gain Trajectory
• Interventions: Behavioral: Learning Early Infant Feeding Cues

• Registration Number: NCT06127914
• Lead Sponsor: Florida State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Study Start: 2026-01-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LEIFc Intervention	Learning Early Infant Feeding Cues	There is only 1 arm of this study. All participants will receive the LEIFc intervention.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.