- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01762631
Remote Food Photography Method in Infants (BabyBottle)
Baby Bottle: Remote Food Photography Method in Infants
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 18 years of age
- Willing to complete 2 study visits at Pennington Biomedical (PBRC)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cohort 1
All participants enrolled between November 2012 and March 2013 under the original protocol.
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Cohort 2
After Cohort 1 was completed, the study investigators changed the protocol to eliminate the photograph/weight of the powdered formula alone in each bottle to reduce burden.
All other protocol procedures remained the same.
Cohort 2 participants enrolled between April 2013 and May 2014.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Kilocalorie (Kcal) Difference Between Methods for All Prepared Bottles
Time Frame: Measures will be performed twice about 5-10 days apart
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Kilocalorie (Kcal) Difference in prepared infant formula intake detected in a bottle between the Remote Food Photography Method (RFPM) and direct weighing Kilocalorie difference between the Remote Food Photography Method and direct weighing with all bottles that were prepared included Kilocalorie difference is Remote Food Photography Method - Direct Weighing |
Measures will be performed twice about 5-10 days apart
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Kilocalorie (Kcal) Difference Between Different Bottle Sizes
Time Frame: Measures will be performed twice about 5-10 days apart
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Kilocalorie difference between the Remote Food Photography Method and direct weighing separately analyzed by the four different bottle sizes that were prepared (2 oz bottles only, 4 oz bottles only, 6 oz bottles only, and 8 oz bottles only). Each participant prepared 3 sets of 2 oz bottles, 3 sets of 4 oz bottles, 3 sets of 6 oz bottles, and 3 sets of 8 oz bottles and all bottles of the specified size were included in the analysis. Kilocalorie difference is Remote Food Photography Method - Direct Weighing |
Measures will be performed twice about 5-10 days apart
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 2 oz Prepared Bottles Only
Time Frame: Measures will be performed twice about 5-10 days apart
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A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 2 oz prepared bottles only. Each participant prepared 3 sets of 2 oz bottles, and all bottles of the specified size were included in the analysis. |
Measures will be performed twice about 5-10 days apart
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Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 4 oz Prepared Bottles Only
Time Frame: Measures will be performed twice about 5-10 days apart
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A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 4 oz prepared bottles only. Each participant prepared 3 sets of 4 oz bottles, and all bottles of the specified size were included in the analysis. |
Measures will be performed twice about 5-10 days apart
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Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 6 oz Prepared Bottles Only
Time Frame: Measures will be performed twice about 5-10 days apart
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A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 6 oz prepared bottles only. Each participant prepared 3 sets of 6 oz bottles, and all bottles of the specified size were included in the analysis. |
Measures will be performed twice about 5-10 days apart
|
|
Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 8 oz Prepared Bottles Only
Time Frame: Measures will be performed twice about 5-10 days apart
|
A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 8 oz prepared bottles only. Each participant prepared 3 sets of 8 oz bottles, and all bottles of the specified size were included in the analysis. |
Measures will be performed twice about 5-10 days apart
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Collaborators and Investigators
Investigators
- Principal Investigator: Leanne M Redman, Ph.D., Pennington Biomedical Research Center
- Principal Investigator: Corby Martin, Ph.D., Pennington Biomedical Research Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PBRC 12035
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