Testing LEIFc in the Community

NCT06898190 | Completed

• 1 other identifier: STUDY00002895
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

infants; infant feeding; breastfeeding; health promotion; infant growth; childhood obesity prevention

Outcome Measures

Primary Outcomes (1)

• Responsive Infant Feeding

  Subjective (via survey) and objective (via video) measurement of responsive feeding will be collected pre-post intervention visits. The Infant Feeding Questionnaire will 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.

  Pre-intervention (infant age 1 month) to post-intervention (infant age 4 months)

Secondary Outcomes (3)

• Duration of Breastfeeding

  weeks since birth

• Age of complementary food introduction

  weeks since birth

• Infant weight-for-length z-score (WLz)

  birth to 4 months

Study Arms (1)

LEIFc

EXPERIMENTAL

The LEIFc intervention was developed by the research team and includes several key components, including a prenatal visit to introduce infants' early feeding cues and in the moment coaching supports during feeding routines after the baby is born. The SS-OO-PP-RR ("super," Setting the Stage, Observation and Opportunities, Problem Solving and Planning, Reflection and Review) coaching approach is a hallmark of the intervention that is intended to build caregiver confidence in reading their child's cues with in the moment practice and feedback as well as problem solving and reflecting on what is working or what needs to be adapted.

Behavioral: Learning Early Infant Feeding Cues (LEIFc)

Interventions

Learning Early Infant Feeding Cues (LEIFc) BEHAVIORAL

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.

LEIFc

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be pregnant to be enrolled thus must be biologically female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant in the 3rd trimester (28 weeks or beyond) of a healthy pregnancy
• pregnant with a single fetus
• years or older
• no known complications or genetic anomalies of the infant that would interfere with feeding or growth after birth
• English or Spanish speaking

You may not qualify if:

• mother less than 18 years
• will not have custody of the infant after birth

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

• Bahorski J, Romano M, McDougal JM, Kiratzis E, Pocchio K, Paek I. Development of an Individualized Responsive Feeding Intervention-Learning Early Infant Feeding Cues: Protocol for a Nonrandomized Study. JMIR Res Protoc. 2023 Feb 28;12:e44329. doi: 10.2196/44329.

  PMID: 36853761 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Obesity-Related Behavioral Intervention Trials (ORBIT)

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 27, 2025
• Study Start: April 10, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)