Bottle FeedingOBS-IINCT02519179
Influence of Bottle-Type of Infant Feeding Behavior
A study testing Opaque, weighted bottle and Clear, conventional bottle in people with Bottle Feeding, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial summary
The objective this 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
- Bottle Feeding
- What is being tested?
- Opaque, weighted bottle and Clear, conventional bottle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2018
- 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 0-6 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.
United States1 site
California Polytechnic State University
San Luis Obispo, California, 93401
About this study
The objective this 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
- Bottle Feeding
- Being tested
- Opaque, weighted bottle, Clear, conventional bottle
- Medical subject headings
- Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opaque, weighted bottleBehavioural
This is the experimental condition; mothers will be asked to feed their infants from an opaque, weighted bottle.
Clear, conventional bottleBehavioural
This is the control condition; mothers will be asked to feed their infants from a clear, conventional bottle.
| Study group | Role | What they receive |
|---|---|---|
| Conventional vs. Opaque, Weighted Bottle | Experimental | This is a within-subject experiment; mothers will be asked to feed their infants from a clear, conventional bottle during one visit and an opaque, weighted bottle during the other visit. Order of conditions will be counterbalanced. Receives: Behavioral: Opaque, weighted bottle; Behavioral: Clear, conventional bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant intake
Infant intake within a feeding (mL) assessed by weighing the bottle before and after a feeding.
Measured: 3-hour period
Maternal responsiveness
Maternal responsiveness to infant cues during a feeding assessed by Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale.
Measured: 3-hour period
Secondary outcomes (1)
Maternal acceptance/perception of intervention
Maternal perception/acceptance of the bottles during a feeding assessed through a mixed methods interview.
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 posted10 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2017
- Study completionAug 2018
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a within-subject study; mothers are observed during both feeding conditions.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Ventura, California Polytechnic State University-San Luis Obispo
- Investigators
- Alison K Ventura, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519179
- Sponsor's protocol ID
- 00000
- Acronym
- OBS-II
- Status last verified
- Jan 2018
- First submitted
- 5 Aug 2015
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 25445988
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Bottle-Type of Infant Feeding Behavior
- ClinicalTrials.gov ID
- NCT02519179
- Acronym / sponsor ID
- OBS-II / 00000
- Conditions
- Bottle Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 10 Aug 2015 (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 this 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a within-subject study; mothers are observed during both feeding conditions.
| Arm | Type | Receives |
|---|---|---|
| Conventional vs. Opaque, Weighted Bottle | Experimental | Behavioral: Opaque, weighted bottle, Behavioral: Clear, conventional bottleThis is a within-subject experiment; mothers will be asked to feed their infants from a clear, conventional bottle during one visit and an opaque, weighted bottle during the other visit. Order of conditions will be counterbalanced. |
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 0-6 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 |
|---|---|---|
| Opaque, weighted bottleThis is the experimental condition; mothers will be asked to feed their infants from an opaque, weighted bottle. | Behavioural | Conventional vs. Opaque, Weighted Bottle |
| Clear, conventional bottleThis is the control condition; mothers will be asked to feed their infants from a clear, conventional bottle. | Behavioural | Conventional vs. Opaque, Weighted Bottle |
Primary outcome
Infant intake
Time frame: 3-hour period
Infant intake within a feeding (mL) assessed by weighing the bottle before and after a feeding.
Maternal responsiveness
Time frame: 3-hour period
Maternal responsiveness to infant cues during a feeding assessed by Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale.
1 secondary outcome
Maternal acceptance/perception of intervention
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 9 Oct 2018.
- Background: 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.
Related trials for Bottle Feeding
Recruiting
The Bottle Optimization Testing Tiny Little Eaters Study
Childhood Obesity
RecruitingPhase 2/3
BabySTrong II taVNS Feeding Trial
Feeding Delays, Neonates and Term Infants
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
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opaque, weighted bottle and Clear, conventional bottle in people with Bottle Feeding, run by California Polytechnic State University-San Luis Obispo 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 9 Oct 2018. 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 (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 NCT02519179, 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 9 Oct 2018.