ObesityPhase 2NCT01043978
Prevention of Overfeeding During Infancy
A Phase 2 study testing Use of baby bottle nipple in people with Obesity, run by University of California, Davis at 1 site in United States.
Trial summary
The overall goal of this project is to identify strategies to prevent overfeeding during infancy. One objective is to evaluate the impact on intake of allowing the infant greater control over the amount consumed when feeding from a bottle. Read more about this study
- Who is it for?
- Ages Up to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Use of baby bottle nipple
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2012
- Phase
- Phase 2
- 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 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant born at > 37 weeks gestation
- Infant weighed >2500 g at birth
- Infant is apparently healthy
- Mother speaks English
- Mother is 18 years of age or older
- Mother/infant pair lives within a 10-mile radius around the UC Davis Medical Center in Sacramento, CA
- Mother plans to use a bottle (at least occasionally) to feed her infant before he/she is 3 months old.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
The overall goal of this project is to identify strategies to prevent overfeeding during infancy. One objective is to evaluate the impact on intake of allowing the infant greater control over the amount consumed when feeding from a bottle. This will be accomplished via the use of a novel nipple that mimics (functionally) the nipple of a human breast and allows the infant to self-regulate milk flow. The second objective is to evaluate the relationship between parental feeding styles and infant intake.
- Conditions
- Obesity
- Being tested
- Use of baby bottle nipple
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of baby bottle nippleBehavioural
Participants will be assigned to either a novel nipple or a conventional nipple to use when feeding their infants with the bottle
| Study group | Role | What they receive |
|---|---|---|
| Novel nipple | Experimental | Not described Receives: Behavioral: Use of baby bottle nipple |
| Coventional nipple | Active comparator | Not described Receives: Behavioral: Use of baby bottle nipple |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake
Measured: per feed
Secondary outcomes (1)
Growth
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn G Dewey, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043978
- Sponsor's protocol ID
- 200715679
- Status last verified
- Aug 2012
- First submitted
- 5 Jan 2010
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Overfeeding During Infancy
- ClinicalTrials.gov ID
- NCT01043978
- Acronym / sponsor ID
- 200715679
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Jan 2010 (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 overall goal of this project is to identify strategies to prevent overfeeding during infancy. One objective is to evaluate the impact on intake of allowing the infant greater control over the amount consumed when feeding from a bottle. This will be accomplished via the use of a novel nipple that mimics (functionally) the nipple of a human breast and allows the infant to self-regulate milk flow. The second objective is to evaluate the relationship between parental feeding styles and infant intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel nipple | Experimental | Behavioral: Use of baby bottle nipple |
| Coventional nipple | Active comparator | Behavioral: Use of baby bottle nipple |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infant born at > 37 weeks gestation
- Infant weighed >2500 g at birth
- Infant is apparently healthy
- Mother speaks English
- Mother is 18 years of age or older
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Use of baby bottle nippleParticipants will be assigned to either a novel nipple or a conventional nipple to use when feeding their infants with the bottle | Behavioural | Coventional nipple, Novel nipple |
Primary outcome
Intake
Time frame: per feed
1 secondary outcome
Growth
Time frame: 4 months
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 24 Aug 2012.
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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.
Kathryn G Dewey, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Use of baby bottle nipple in people with Obesity, run by University of California, Davis 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 7 inclusion and 0 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 24 Aug 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intake (time frame: per feed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2012.