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Testing LEIFc in the Community

NCT06898190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-03-27

No results posted yet for this study

Summary

The reason that we are doing this research is to teach mothers ways to communicate with their baby during feeding. Understanding signals a baby gives helps mothers know when and how much to feed their baby which will help the baby grow in a healthy way.

There are 5 study visits, 1 during pregnancy and 4 after the baby is born. At the first visit participants will watch some videos about feeding babies and be provided with information to read about feeding babies, there is also a questionnaire to complete. After the baby is born, a research team member will come to participants' homes at infant age of 1, 2, 3, and 4 months to videotape an infant feeding session. At the visit when the baby is 2 and 3 months of age, the intervention will occur in which the interventionists will provide coaching about responsive feeding before and during a feeding session. The baby's height and weight will be collected and some questionnaires completed. At the last study visit, a research assistant will ask opened ended questions about the study itself, these questions and participant answers will be audio recorded.

Conditions

  • Responsive Infant Feeding
  • Infant Growth

Interventions

BEHAVIORAL

Learning Early Infant Feeding Cues (LEIFc)

Coaching sessions using SS-OO-PP-RR are conducted at infant age of 2 and 3 months. This occurs during an infant feeding session between mother and infant with the interventionists offering coaching specific to responsive feeding during the session. At the conclusion of the visit, the interventionists and mother develop specific strategies to practices prior to the next visit. At the following visit, a discussion of reflection and review occurs prior to the infant feeding session to identify what is going well and what still needs work.

Sponsors & Collaborators

  • Florida State University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-10
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06898190 on ClinicalTrials.gov