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Remote Food Photography Method in Infants (BabyBottle)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01762631
First received: December 17, 2012
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
Estimating Infant Food Intake

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Baby Bottle: Remote Food Photography Method in Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Grams of prepared infant formula detected in a bottle using the Remote Food Photography Method as a validation measure against grams of prepared formula measured via direct weighing [ Time Frame: Measures will be performed twice about 5-10 days apart ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ability of Remote Food Photography Method to measure kilocalories of prepared infant formula [ Time Frame: Measures will be performed twice about 5-10 days apart ] [ Designated as safety issue: No ]
    Inter- and intra- individual preparation variability of kilocalories of prepared infant formula detected


Other Outcome Measures:
  • Variability between caregivers and non-caregivers in kilocalories of prepared infant formula [ Time Frame: Measures will be performed twice about 5-10 days apart ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 75
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • ≥ 18 years of age
  • Willing to complete 2 study visits at Pennington Biomedical (PBRC)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762631

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center
Principal Investigator: Corby Martin, Ph.D. Pennington Biomedical Research Center
  More Information

Additional Information:
PBRC Website description and webscreening link  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01762631     History of Changes
Other Study ID Numbers: PBRC12035
Study First Received: December 17, 2012
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013