The Food Phone Project | NCT01719445

Studies
The Food Phone Project

NCT01719445

Sponsor

Pennington Biomedical Research Center

Status

Completed

Last Update Posted

Nov 4, 2024Actual

Enrollment

53Actual

Phase

Not provided

Conditions

Comparison of Energy Intake Methods

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK089051	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Oct 30, 2012

First Submission Date that Met QC Criteria

Oct 30, 2012

First Posted Date

Nov 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2024

Last Update Posted Date

Nov 4, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Corby K. Martin, Principal Investigator, Pennington Biomedical Research CenterPrincipal Investigator

Lead Sponsor

Pennington Biomedical Research CenterOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

53Actual

Label	Type	Description	Intervention Names
RFPM/Paper and Pen Method

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Doubly Labeled Water (DLW)	Doubly labeled water will be used to measure total daily energy expenditure (TEE) and Energy Intake.	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
The Remote Food Photography Method (RFPM)	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 Outcomes

Measure	Description	Time Frame
Pen-and-paper Food Records	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.

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

50 adolescents will be recruited.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Corby K Martin, PhD	Pennington Biomedical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pennington Biomedical Research Center		Baton Rouge	Louisiana	70808	United States