- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04148560
Free-living Validation of the RFPM in Adolescents (FoodPhone2)
Validity of the Remote Food Photography Method to Measure Food Intake in Adolescents in Free-living Conditions
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Corby K Martin, PhD
- Phone Number: (225) 763-2585
- Email: Corby.Martin@pbrc.edu
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
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
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.
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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
Investigators
- Principal Investigator: Corby K Martin, PhD, Pennington Biomedical Research Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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 2019-053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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