Free-living Validation of the RFPM in Adolescents (FoodPhone2)

March 10, 2024 updated by: Corby K. Martin, Pennington Biomedical Research Center

Validity of the Remote Food Photography Method to Measure Food Intake in Adolescents in Free-living Conditions

The primary aim of this small study is to test the validity of the Remote Food Photography Method and an updated SmartIntake app in a sample of adolescents. The investigators will test the validity (accuracy) of the method/app at estimating energy intake in free-living conditions over approximately three days compared to doubly labeled water. This is a small study that has low statistical power, but will provide important data nonetheless and inform future research.

Study Overview

Detailed Description

Energy intake (EI) is an important predictor of weight gain (1) and accurate methods to measure children's and adolescent's EI are needed. Self-report methods (e.g., 24-hour recall and food records) have their strengths and are frequently used to measure children's EI. Nonetheless, they also have significant limitations, including participant and caregiver burden and lack of near real-time data.

Our group developed the Remote Food Photography Method (RFPM) to measure the EI of adults in near real-time and the validity data in adults are exceptional; the RFPM underestimates EI in laboratory settings by less than 6% and in free-living conditions by less than 7% compared to weighed foods and by less than 4% compared to doubly labeled water (DLW) over 6 days. At the same time, participant burden is drastically reduced compared to self-report methods, as participants are only required to capture images of their food selection and plate waste with a smartphone app and send these images to the laboratory for analysis. This validation study aims to assess the accuracy of the RFPM and SmartIntake app in a sample of adolescents in free-living conditions.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

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

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • boy or girl of any race
  • age between 12 and 18 years
  • willingness to use the RFPM/SmartIntake app for 3 days, in addition to a 1-2 day run-in period
  • willingness to be responsive to study staff when prompted for additional information when using the RFPM/SmartIntake app
  • parental support of the project, except for 18-year-olds

Exclusion Criteria:

  • Individuals may not qualify for this study based on other eligibility criteria not listed. The study coordinator determine this on a case-by-case basis

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study sample
Individuals who participate in this validation study
Participants who enroll will be trained in using the RFPM/SmartIntake app and a food record and will complete the Food Intake Assessment Preference Survey. They will also use both methods to estimate intake during a simulated lab-based meal (they will not eat during this simulated meal). They will be dosed with DLW at this visit and will use the RFPM for the subsequent 1-2 days to get accustomed to using the method, with the following three days comprising the data collection period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Equivalence between energy intake (kcal/day) measured with the RFPM and DLW
Time Frame: 3 days
Energy intake is measured by the RFPM and DLW in kcal per day over 3 days. We will use the mean of the 3 days in the analyses. Two one-sided paired t-tests (α = 0.05 for each) will be performed in this pilot with equivalence bounds at 2% increments between 8% and 34% to determine equivalence in kcal estimates between RFPM and DLW.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference between the RFPM and DLW on kcal/day
Time Frame: 3 days
RFPM - DLW (kcal), with each method measuring energy intake over three days, and the mean of the three days for each method being included in the calculations and analyses.
3 days
Mean percentage error of RFPM relative to DLW
Time Frame: 3 days
MPE = (RFPM - DLW) / DLW × 100
3 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Corby K Martin, PhD, Pennington Biomedical Research Center

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)

October 1, 2020

Primary Completion (Actual)

April 17, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 10, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PBRC 2019-053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to individual de-identified data is possible via Pennington Biomedical Research Center's Data Sharing policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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