Conventional Clear BottleOBSNCT02111694
Influence of Bottle-Type on Infant Feeding Behaviors
A study testing Bottle Type in people with Conventional Clear Bottle and Opaque Weighted Bottle, run by Drexel University at 1 site in United States.
Trial summary
The objective of the proposed research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Conventional Clear Bottle, Opaque Weighted Bottle
- What is being tested?
- Bottle Type
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2014
- 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
- Mothers must be 18 years or older
- Infants must be between 0- and 6-months of age
- Infants must be prior to the introduction of solid foods
Who cannot join
- Preterm birth
- Medical conditions that interfere with feeding
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the proposed research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. The investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. The investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles.
- Conditions
- Conventional Clear Bottle, Opaque Weighted Bottle
- Being tested
- Bottle Type
- Keywords
- infant, intake, satiation, mother, feeding practices, bottle feeding, formula feeding, maternal responsiveness, infant cues
- Medical subject headings
- Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bottle TypeBehavioural
Infants will be fed from a conventional, clear bottle during one feeding and from an opaque, weighted bottle from another feeding
| Study group | Role | What they receive |
|---|---|---|
| Clear versus Opaque Bottle | Experimental | This is a within-subject study; all infants will be exposed to both conditions. Order of presentation will be counterbalanced across infants. Receives: Behavioral: Bottle Type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant intake within a feeding (mL)
assessed by weighing the bottle before and after a feeding
Measured: 3-hour period
Maternal responsiveness to infant cues during a feeding
assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale
Measured: 3-hour period
Secondary outcomes (1)
Maternal perception/acceptance of the bottles during a 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 posted11 Apr 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Conventional Clear BottleStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison K Ventura, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111694
- Sponsor's protocol ID
- OBS-1303001967
- Acronym
- OBS
- Status last verified
- Oct 2015
- First submitted
- 26 Mar 2014
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ventura AK, Pollack Golen R. A pilot study comparing opaque, weighted bottles with conventional, clear bottles for infant feeding. Appetite. 2015 Feb;85:178-84. doi: 10.1016/j.appet.2014.11.028. Epub 2014 Nov 28.
PubMed 25445988Golen RB, Ventura AK. Mindless feeding: Is maternal distraction during bottle-feeding associated with overfeeding? Appetite. 2015 Aug;91:385-92. doi: 10.1016/j.appet.2015.04.078. Epub 2015 May 4.
PubMed 25953601
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Bottle-Type on Infant Feeding Behaviors
- ClinicalTrials.gov ID
- NCT02111694
- Acronym / sponsor ID
- OBS / OBS-1303001967
- Conditions
- Conventional Clear Bottle, Opaque Weighted Bottle
- Keywords
- infant, intake, satiation, mother, feeding practices, bottle feeding, formula feeding, maternal responsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Apr 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.
The objective of the proposed research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. The investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. The investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clear versus Opaque Bottle | Experimental | Behavioral: Bottle TypeThis is a within-subject study; all infants will be exposed to both conditions. Order of presentation will be counterbalanced across infants. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Mothers must be 18 years or older
- Infants must be between 0- and 6-months of age
- Infants must be prior to the introduction of solid foods
Key exclusion criteria (2 listed)
- Preterm birth
- Medical conditions that interfere 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 |
|---|---|---|
| Bottle TypeInfants will be fed from a conventional, clear bottle during one feeding and from an opaque, weighted bottle from another feeding | Behavioural | Clear versus Opaque Bottle |
Primary outcome
Infant intake within a feeding (mL)
Time frame: 3-hour period
assessed by weighing the bottle before and after a feeding
Maternal responsiveness to infant cues during a feeding
Time frame: 3-hour period
assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale
1 secondary outcome
Maternal perception/acceptance of the bottles during a feeding
Time frame: 3-hour period
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 30 Oct 2015.
- Results publication: PubMed 25445988Ventura AK, Pollack Golen R. A pilot study comparing opaque, weighted bottles with conventional, clear bottles for infant feeding. Appetite. 2015 Feb;85:178-84. doi: 10.1016/j.appet.2014.11.028. Epub 2014 Nov 28.
- Derived from this study: PubMed 25953601Golen RB, Ventura AK. Mindless feeding: Is maternal distraction during bottle-feeding associated with overfeeding? Appetite. 2015 Aug;91:385-92. doi: 10.1016/j.appet.2015.04.078. Epub 2015 May 4.
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
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bottle Type in people with Conventional Clear Bottle and Opaque Weighted Bottle, run by Drexel University at 1 site 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 3 inclusion and 2 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 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 within a feeding (mL) (time frame: 3-hour period). The study lists 2 primary outcomes in all. 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 NCT02111694, which also lists 2 linked publications.
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 30 Oct 2015.