Remote Food Photography Method in Infants (BabyBottle)

August 23, 2021 updated by: Leanne Redman, Pennington Biomedical Research Center

Baby Bottle: Remote Food Photography Method in Infants

The purpose of this study is to determine if digital photography on a Smartphone and the Remote Food Photography Method (RFPM) can estimate infant formula intake. This is a validation study; there is no hypothesis.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Up to 75 men and women will be recruited to participate in a 2-week pilot study involving infant formula preparation. Participation is open to all adult individuals.

Description

Inclusion Criteria:

  • ≥ 18 years of age
  • Willing to complete 2 study visits at Pennington Biomedical (PBRC)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1
All participants enrolled between November 2012 and March 2013 under the original protocol.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kilocalorie (Kcal) Difference Between Methods for All Prepared Bottles
Time Frame: Measures will be performed twice about 5-10 days apart

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kilocalorie (Kcal) Difference Between Different Bottle Sizes
Time Frame: Measures will be performed twice about 5-10 days apart

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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
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

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
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 17, 2012

First Submitted That Met QC Criteria

January 4, 2013

First Posted (Estimate)

January 8, 2013

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PBRC 12035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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