Short-term Effects of Paced Bottle-Feeding on Feeding Interactions

NCT05780944 | Completed

• 1 other identifier: 2018-253-CP
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Current infant feeding recommendations focus on promoting responsive feeding, which is widely recognized as the ideal way to feed infants because it is associated with healthier eating behaviors and growth outcomes for infants. Unfortunately, many bottle-feeding families receive inadequate support for learning responsive bottle-feeding practices because breastfeeding support is prioritized in healthcare settings. Promotion of breastfeeding is an important focus for public health efforts, but a significant proportion of families bottle-feed their infants, either exclusively or in combination with breastfeeding. Thus, bottle-feeding remains a ubiquitous part of infant feeding and evidence-based strategies are needed to support bottle-feeding families. One promising strategy is the Paced Bottle-Feeding (PBF) method, which incorporates many ideas and feeding practices consistent with the concept of responsive feeding. This approach to bottle-feeding aims to mimic the aspects of breastfeeding that promote balanced control between caregiver and infant and allow the infant to set the pace of the feeding in response to feelings of hunger and fullness. Although PBF is sometimes taught in perinatal education settings, teaching new parents about PBF is not an evidence-based practice because there have been no empirical studies evaluating the effectiveness of PBF for promoting responsive feeding for parents and healthy intake and weight outcomes for infants. Thus, despite the conceptual promise of PBF for promoting responsive bottle-feeding interactions, research is needed to determine whether PBF is effective and identify whether any limitations of this method exist. This study is a within-subject, experimental study wherein mother-infant dyads will be observed during breastfeeding and typical bottle-feeding interactions. Mothers will then be taught the PBF method and observed during a PBF interaction. This design will allow for direct testing of the purported benefits of PBF over typical bottle-feeding and whether PBF makes the experience of bottle-feeding more equivalent to the experience of breastfeeding. The overarching aims of this study are to explore the ways in which bottle-feeding can go well and identify mechanisms through which bottle-feeding families can be supported to promote healthy intake and weight gain trajectories for their infants.

Conditions

Mother-Infant Interaction; Breastfeeding; Bottle Feeding

Keywords

paced bottle-feeding; feeding interactions; maternal feeding practices; responsive feeding; infant feeding; breastfeeding; bottle-feeding

Outcome Measures

Primary Outcomes (8)

• Change in Infant Milk Intake between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions

  Infant milk intake in mL, assessed by weighing the infant before and after each feeding condition

  3 visits across a 1 week period

• Change in Meal Duration between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions

  Duration of the observed meal in minutes (min), determined by trained video coders masked to study hypotheses

  3 visits across a 1 week period

• Change in Rate of Feeding between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions

  Infant milk intake divided by meal duration (mL/min)

  3 visits across a 1 week period

• Change in Frequency of Spitting Up During and After the Meal between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions

  Determined by trained video coders masked to study hypotheses

  3 visits across a 1 week period

• Change in Maternal Sensitivity to Infant Cues between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions

  Determined by video coders masked to study hypotheses and certified in the Nursing Child Assessment Caregiver-Child Interaction Feeding Scale (NCAFS); possible Maternal Sensitivity to Infant Cues scores range from 0-16 with higher scores representing greater maternal sensitivity to infant cues

  3 visits across a 1 week period

• Change in Maternal Responsiveness to Infant Distress between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions

  Determined by video coders masked to study hypotheses and certified in the Nursing Child Assessment Caregiver-Child Interaction Feeding Scale (NCAFS); possible Maternal Responsiveness to Infant Distress scores range from 0-11 with higher scores representing greater maternal responsiveness to infant distress

  3 visits across a 1 week period

• Change in Infant Clarity of Cues between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions

  Determined by video coders masked to study hypotheses and certified in the Nursing Child Assessment Caregiver-Child Interaction Feeding Scale (NCAFS); possible Infant Clarity of Cues scores range from 0-15 with higher scores representing greater infant clarity of cues

  3 visits across a 1 week period

• Change in Infant Responsiveness to Caregiver between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions

  Determined by video coders masked to study hypotheses and certified in the Nursing Child Assessment Caregiver-Child Interaction Feeding Scale (NCAFS); possible Infant Responsiveness to Caregiver scores range from 0-11 with higher scores representing greater infant responsiveness to the caregiver

  3 visits across a 1 week period

Study Arms (2)

Breastfeeding First, Bottle-feeding Second, PBF Third

EXPERIMENTAL

Mother-infant dyads will visit the laboratory on three different days. During the first visit, they will be observed during breastfeeding. During the second visit, they will be observed during bottle-feeding. During the third visit, the mother will be taught the PBF approach and will be observed using it during bottle-feeding.

Behavioral: Paced Bottle-Feeding Education

Bottle-feeding First, Breastfeeding Second, PBF Third

EXPERIMENTAL

Mother-infant dyads will visit the laboratory on three different days. During the first visit, they will be observed during bottle-feeding. During the second visit, they will be observed during breastfeeding. During the third visit, the mother will be taught the PBF approach and will be observed using it during bottle-feeding.

Behavioral: Paced Bottle-Feeding Education

Interventions

Paced Bottle-Feeding Education BEHAVIORAL

Participants will be asked to review an educational handout that outlines how to implement PBF during bottle-feeding interactions. Participants will then be asked to watch a video that further describes PBF and illustrates how to implement it with a live infant. A trained research assistant will then answer questions, further explain PBF, and demonstrate PBF with a baby doll, using a standardized script

Bottle-feeding First, Breastfeeding Second, PBF Third; Breastfeeding First, Bottle-feeding Second, PBF Third

Eligibility Criteria

• Age: Up to 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Speaks English or Spanish
• Mother 18-40-years of age
• Infant 0-24 weeks of age
• Dyad is current breastfeeding and bottle-feeding
• Infant has not been introduced to solid foods

You may not qualify if:

• Infant was born preterm (\<37 weeks)

Sponsors & Collaborators

• California Polytechnic State University-San Luis Obispo: lead

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93401, United States

Location

Related Links

• Study Website

MeSH Terms

Conditions

Breast Feeding; Bottle Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Alison K Ventura, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After each visit, three trained coders who are unaware of the experimental conditions and hypotheses of the study will score the videotaped records using an event recorder program (Observer XT, version 16; Noldus Information Technology, Heerlen, the Netherlands).
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 23, 2023
• Study Start: February 10, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)