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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Drexel University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Monell Chemical Senses Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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