Classical MusicMFSNCT02517970
Observing Infant Feeding Interactions
A study testing Technology distraction in people with Classical Music and Television Show, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial summary
The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of environmental distractions on a mothers' ability to recognize and feed in response to infants' feeding cues. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Classical Music, Television Show
- What is being tested?
- Technology distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 1 Dec 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
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 of the proposed research is to conduct a within-subject experimental study that will assess the effect of environmental distractions on a mothers' ability to recognize and feed in response to infants' feeding cues. Investigators hypothesize that mothers will spend significantly more time looking at their technology compared to looking at their infant, which will be negatively associated with the mothers' responsiveness to her infant. This will have a positive association with infant intake during the feeding. Investigators also hypothesize that mothers will show less sensitivity when distracted when compared to when they are not distracted.
- Conditions
- Classical Music, Television Show
- Being tested
- Technology distraction
- Keywords
- infant feeding, breast-feeding, bottle-feeding, feeding interactions, maternal feeding practices
- Medical subject headings
- Breast Feeding, Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology distractionBehavioural
Infants will be fed with classical music playing in the background for one feeding and with a television show playing for the mother to watch during the other.
| Study group | Role | What they receive |
|---|---|---|
| Classical Music versus Television show | Experimental | This is within-subject study; all infants will be exposed to both conditions. Order of presentation will counterbalanced across infants. Receives: Behavioral: Technology distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant intake within a feeding (mL)
Infant intake within a feeding (mL) assessed by weighing the bottle or infant, depending on the type of feeding, before and after the feeding.
Measured: 2-hour period
Maternal responsiveness
Maternal responsiveness to infant cues during a feeding assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale.
Measured: 2-hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2017
- Study completion1 Dec 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 Classical MusicStudies 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
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT02517970
- Sponsor's protocol ID
- 00001
- Acronym
- MFS
- Status last verified
- Feb 2019
- First submitted
- 5 Aug 2015
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Golen 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 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observing Infant Feeding Interactions
- ClinicalTrials.gov ID
- NCT02517970
- Acronym / sponsor ID
- MFS / 00001
- Conditions
- Classical Music, Television Show
- Keywords
- infant feeding, breast-feeding, bottle-feeding, feeding interactions, maternal feeding practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 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
- 1 Dec 2018 (actual)
- First posted
- 7 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 of the proposed research is to conduct a within-subject experimental study that will assess the effect of environmental distractions on a mothers' ability to recognize and feed in response to infants' feeding cues. Investigators hypothesize that mothers will spend significantly more time looking at their technology compared to looking at their infant, which will be negatively associated with the mothers' responsiveness to her infant. This will have a positive association with infant intake during the feeding. Investigators also hypothesize that mothers will show less sensitivity when distracted when compared to when they are not distracted.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Classical Music versus Television show | Experimental | Behavioral: Technology distractionThis is within-subject study; all infants will be exposed to both conditions. Order of presentation will counterbalanced across infants. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Mothers must be 18 years or older
- Infants must be between 0-6 months of age
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 |
|---|---|---|
| Technology distractionInfants will be fed with classical music playing in the background for one feeding and with a television show playing for the mother to watch during the other. | Behavioural | Classical Music versus Television show |
Primary outcome
Infant intake within a feeding (mL)
Time frame: 2-hour period
Infant intake within a feeding (mL) assessed by weighing the bottle or infant, depending on the type of feeding, before and after the feeding.
Maternal responsiveness
Time frame: 2-hour period
Maternal responsiveness to infant cues during a feeding assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale.
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 4 Feb 2019.
- Background: 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.
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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 Technology distraction in people with Classical Music and Television Show, 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 2 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 4 Feb 2019. 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: 2-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 NCT02517970, 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 4 Feb 2019.