Bottle FeedingRFSNCT02284152
Responsive Feeding Study
A study testing infant-led feeding in people with Bottle Feeding, run by Drexel University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Bottle Feeding
- What is being tested?
- infant-led feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Formula-feeding
- Prior to the introduction of solid foods
- Infants 0 to 6 months of age
- Mothers 18 to 40 years of age
Who cannot join
- Exclusively breast-feeding
- Preterm
- Medical conditions that interfered with feeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Drexel University
Philadelphia, Pennsylvania, 19102
Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104
California Polytechnic State University
San Luis Obispo, California, 93407
About this study
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.
Read the 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).
- Conditions
- Bottle Feeding
- Being tested
- infant-led feeding
- Keywords
- bottle feeding, feeding behavior, infants, mothers, responsive feeding, maternal feeding practices, maternal feeding styles
- Medical subject headings
- Bottle Feeding, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infant-led feedingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Typical versus Infant-Led feeding | Experimental | 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. Receives: Behavioral: infant-led feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Intake
Infant intake was assessed by weighing the bottle before and after the feeding
Measured: 3-hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startJan 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bottle FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- Monell Chemical Senses Center
- Responsible party
- Principal investigator, Alison Ventura, Drexel University
- Investigators
- Alison K Ventura, PhD, Principal investigator, Cal Poly University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284152
- Sponsor's protocol ID
- 809649
- Acronym
- RFS
- Status last verified
- Nov 2014
- First submitted
- 3 Nov 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ventura AK, Inamdar LB, Mennella JA. Consistency in infants' behavioural signalling of satiation during bottle-feeding. Pediatr Obes. 2015 Jun;10(3):180-7. doi: 10.1111/ijpo.250. Epub 2014 Jul 3.
PubMed 24990443
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsive Feeding Study
- ClinicalTrials.gov ID
- NCT02284152
- Acronym / sponsor ID
- RFS / 809649
- Conditions
- Bottle Feeding
- Keywords
- bottle feeding, feeding behavior, infants, mothers, responsive feeding, maternal feeding practices, maternal feeding styles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Monell Chemical Senses Center
- Study start
- Jan 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Typical versus Infant-Led feeding | Experimental | Behavioral: infant-led feedingThis 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. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Formula-feeding
- Prior to the introduction of solid foods
- Infants 0 to 6 months of age
- Mothers 18 to 40 years of age
Key exclusion criteria (3 listed)
- Exclusively breast-feeding
- Preterm
- Medical conditions that interfered with feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infant-led feedingmothers' 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. | Behavioural | Typical versus Infant-Led feeding |
Primary outcome
Infant Intake
Time frame: 3-hour period
Infant intake was assessed by weighing the bottle before and after the feeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Background: PubMed 24990443Ventura AK, Inamdar LB, Mennella JA. Consistency in infants' behavioural signalling of satiation during bottle-feeding. Pediatr Obes. 2015 Jun;10(3):180-7. doi: 10.1111/ijpo.250. Epub 2014 Jul 3.
Related trials for Bottle Feeding
Recruiting
Positive Feeding of the Preterm Infant
Preterm Infant, Breast Feeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison K Ventura, PhD principal investigator
Cal Poly University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infant-led feeding in people with Bottle Feeding, run by Drexel University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Intake (time frame: 3-hour period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02284152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014; AzTrials last refreshed its copy on 27 Oct 2026.