The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles
| Tracking Information | |||||
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| First Received Date ICMJE | January 31, 2012 | ||||
| Last Updated Date | April 22, 2013 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Food intake [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Rate of intake, volume of intake, duration of meal |
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| Original Primary Outcome Measures ICMJE |
Body fat [ Time Frame: Two-weeks ] [ Designated as safety issue: No ] Measured by air-displacement plethysmography |
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| Change History | Complete list of historical versions of study NCT01526018 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
Food intake [ Time Frame: Two weeks ] [ Designated as safety issue: No ] Free-living volume of formula intake; rate, duration and volume of intake during meal test in the clinic. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The purpose of this study is to pilot test whether a novel infant feeding bottle changes how much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided in a standard bottle. Exclusively formula-fed infants and their caregiver will be provided with the novel feeding bottle and caregivers will be asked to acclimate their infant to this bottle during the next several weeks. Once acclimated, infants will undergo two weighed, timed, and videotaped test meals on two separate days; one with the novel bottle and one with their standard bottle, in random order. It is hypothesized that when the novel bottle is used, infants bottle will consume smaller meals and will have a longer meal duration, as compared to when a standard bottle is used. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Bottle-fed infants aged 1-6 months |
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| Condition ICMJE | Infant Feeding Behavior | ||||
| Intervention ICMJE | Behavioral: Podee bottle
Infants will acclimate to the Podee bottle over the course of several weeks. All infants will consume meals from the Podee and their usual bottles. |
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| Study Group/Cohort (s) | Novel bottle
Intervention: Behavioral: Podee bottle |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Month to 6 Months | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01526018 | ||||
| Other Study ID Numbers ICMJE | F110921001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Paula Chandler-Laney, PhD, University of Alabama at Birmingham | ||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | University of Alabama at Birmingham | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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