Responsive Feeding Study (RFS)

November 3, 2014 updated by: Alison Ventura, Drexel University
In the present study, we tested a novel approach to understanding infant bottle-feeding interactions: experimentally manipulating bottle-feeding conditions to better understand maternal and infant influences on overfeeding, as well as individual differences in risk for overfeeding. Specifically, we observed mother-infant dyads during a typical, "mother-led" feeding, during which mothers were given no instruction regarding how or how much to feed their infants (hereafter referred to as a "typical feeding" [TF]), as well as during an "infant-led" (IL) feeding, wherein we minimized the mothers' influence on the feeding and ensured the feed was in response to the infants' hunger and fullness cues. Using this within-subject, objective, and experimental approach, the present study aimed to: 1) directly measure the extent to which overfeeding occurs during bottle-feeding and 2) describe the characteristics of infants and mothers that overfeed during bottle-feeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each mother-infant dyad came to our laboratory on two different days, separated by an average of 2.1 ± 0.4 days. The two testing sessions occurred at the same time of day to control for infants' circadian rhythmicity. Mothers were instructed to bring two of their infants' typical bottles filled with their infants' typical formula to each testing session. Mothers were videotaped while feeding their infants on both days. The first day of testing was always the Typical Feeding (TF) condition because the only instruction given to the mother was: "Please feed your infant as you normally would at home." The second day of testing was always the Infant-Led (IL) condition, wherein we used a protocol developed and established in our laboratory to control for a number of factors to allow for evaluation of infants' hedonic and behavioral responses independent of the parent and experimenter. The feeding protocol during the IL condition entailed the following steps, which were facilitated by the experimenter: (1) feeding sessions began when the experimenter observed the infant displaying signs of hunger (e.g., mouthing, rooting, fussing) and the mother verified that the infant was hungry; (2) the mother was instructed not to talk to her infant and to remain as neutral as possible; (3) the mother was also instructed to feed her infant at his/her customary pace; (4) the experimenter ended the feeding when the infant displayed signs of fullness (e.g., turning head and/or body away from the bottle, biting or chewing on the nipple, spiting the nipple out) on at least three consecutive occasions. If the infant finished the bottle before signaling fullness, the experimenter gave the mother the other bottle to ensure that infant intake was not limited by formula availability. During both study days, consumption during the feeding session was assessed by weighing the bottles before and after each feeding using a top loading balance (model PM 15; Mettler, Greifensee, Switzerland).

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Luis Obispo, California, United States, 93407
        • California Polytechnic State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Monell Chemical Senses Center
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Formula-feeding
  • Prior to the introduction of solid foods
  • Infants 0 to 6 months of age
  • Mothers 18 to 40 years of age

Exclusion Criteria:

  • Exclusively breast-feeding
  • Preterm
  • Medical conditions that interfered with feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Typical versus Infant-Led feeding
This is a within-subject study; all infants and mothers will be exposed to both conditions (typical feeding versus infant-led feeding conditions). Order of presentation will be counterbalanced across infant/mother dyads.
Behavioral: infant-led feeding
mothers' feeding practices and infant intakes were compared between a typical feeding condition and an infant-led feeding condition, where the experimenter ensured the feeding was in response to infant hunger and fullness cues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Intake
Time Frame: 3-hour period
Infant intake was assessed by weighing the bottle before and after the feeding
3-hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drexel University

Collaborators

Monell Chemical Senses Center

Investigators

  • Principal Investigator: Alison K Ventura, PhD, Cal Poly University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 809649

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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