- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01719445
The Food Phone Project (FPP)
January 15, 2016 updated by: Corby K. Martin, Pennington Biomedical Research Center
Remote Food Photography for the Real-time Measurement of Children's Food Intake
The Primary Aim of the project is to modify the RFPM for adolescents and to address the concerns identified by the reviewers of the first grant application.
We will then test the RFPM's validity (accuracy) compared to the validity of pen-and-paper food records.
Study Overview
Status
Completed
Conditions
Detailed Description
The Primary Aim of the project is to modify the RFPM for adolescents and to address the concerns identified by the reviewers of the first grant application.
We will then test the RFPM's validity (accuracy) compared to the validity of pen-and-paper food records.
Our experience and the literature indicate that the RFPM is acceptable and feasible in school settings.
Following modification of the RFPM and pilot testing with 4 adolescents, we will test the reliability and validity of both the RFPM and food records when used by 60 adolescents (12 to 18 years of age).
During one week, participants will use the RFPM and during another week they will use food records (the order will be balanced across participants).
The accuracy of each method will be examined by comparing energy and nutrient intake (collectively referred to as food intake or FI) to three gold standards: 1) doubly labeled water or DLW (energy intake only, or EIDLW), 2) a laboratory-based test meal (FILaboratory), and 3) food intake during lunch in a school cafeteria (FISchool).
User-satisfaction and participant burden will also be compared between methods, and a cost-effectiveness analysis will determine if and under what conditions one method is more cost-effective than the other.
Study Type
Observational
Enrollment (Actual)
53
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
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
50 adolescents will be recruited.
Description
Inclusion Criteria:
- boy or girl of any race
- age 12 to 18 years, inclusive
- willing to use the RFPM for one week and pen-and-paper food records for one week
- willing to complete one laboratory-based food test during week 3
- willing to use the RFPM and food records during the laboratory-based test.
Exclusion Criteria:
-weight unstable (>1.1 pounds weight change in one week based on regressed daily body weights).
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 |
---|
RFPM/Paper and Pen Method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Doubly Labeled Water (DLW)
Time Frame: 2 weeks
|
Doubly labeled water will be used to measure total daily energy expenditure (TEE) and Energy Intake.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Remote Food Photography Method (RFPM)
Time Frame: 7 days
|
In brief, adolescents will be trained to use a Smartphone and the Food Image App to capture images of their food selection and plate waste and to send the data packets to Food Photo II via the wireless network.
|
7 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pen-and-paper Food Records
Time Frame: 7 days
|
Participants will be instructed how to keep a food record and estimate portion size during a session at the Center.
Participants will also receive a packet containing the food protocol outline, food record form, guide to portion sizes, guidelines for description of foods, and tips for recording food intake.
Participants will be instructed to record everything they eat or drink, recording the food item, portion size, time of consumption, and meal designation.
|
7 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
October 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
October 30, 2012
First Submitted That Met QC Criteria
October 30, 2012
First Posted (Estimate)
November 1, 2012
Study Record Updates
Last Update Posted (Estimate)
January 18, 2016
Last Update Submitted That Met QC Criteria
January 15, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PBRC 10040
- R01DK089051 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Comparison of Energy Intake Methods
-
Wake Forest University Health SciencesWithdrawn
-
Ankara Diskapi Training and Research HospitalUnknownComparison of Different Laryngeal Mask Wearing MethodsTurkey
-
Wageningen UniversityTNO; Gelderse Vallei Hospital; Bonumose, Inc.RecruitingEnergy Intake | Energy MetabolismNetherlands
-
University of South CarolinaCompleted
-
Université de MontréalUnknownEnergy IntakeCanada
-
Pennington Biomedical Research CenterActive, not recruitingFood Intake | Energy Intake | Dietary Assessment | Food PhotographyUnited States
-
Pennington Biomedical Research CenterCompletedeHealth | Breastfeeding | Energy IntakeUnited States
-
Mount Saint Vincent UniversityUniversity of Toronto; IWK Health CentreCompleted
-
KU LeuvenRecruitingAppetite Regulation | Energy IntakeBelgium