Learning Early Infant Feeding Cues (LEIFc)

Florida State University

Status: Not yet enrolling

Conditions: Responsive Feeding; Weight Gain Trajectory; Infants

Treatments: Behavioral: Learning Early Infant Feeding Cues

Study type: Interventional

Funder types: Other

Identifiers

NCT06127914

STUDY00004685

Details and patient eligibility

About

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.

Enrollment: 39 estimated patients

Sex: Female

Ages: 2 weeks to 34 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

LEIFc Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Learning Early Infant Feeding Cues