Free-living Validation of the RFPM in Adolescents

NCT04148560 | Completed

• 1 other identifier: PBRC 2019-053
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dietary Assessment; Energy Intake; Food Intake; Food Photography

Outcome Measures

Primary Outcomes (1)

• Equivalence between energy intake (kcal/day) measured with the RFPM and DLW

  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 Outcomes (2)

• Mean difference between the RFPM and DLW on kcal/day

  3 days

• Mean percentage error of RFPM relative to DLW

  3 days

Study Arms (1)

Study sample

OTHER

Individuals who participate in this validation study

Other: Tests of the validity of the RFPM and SmartIntake app.

Interventions

Tests of the validity of the RFPM and SmartIntake app. OTHER

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.

Study sample

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Study Officials

• Corby K Martin, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 1, 2019
• Study Start: October 1, 2020
• Primary Completion: April 17, 2023
• Study Completion: December 31, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)