- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01719445
The Food Phone Project (FPP)
15. januar 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
53
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70808
- Pennington Biomedical Research Center
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
50 adolescents will be recruited.
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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RFPM/Paper and Pen Method
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Doubly Labeled Water (DLW)
Tidsramme: 2 weeks
|
Doubly labeled water will be used to measure total daily energy expenditure (TEE) and Energy Intake.
|
2 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The Remote Food Photography Method (RFPM)
Tidsramme: 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.
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7 days
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pen-and-paper Food Records
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Corby K Martin, PhD, Pennington Biomedical Research Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2012
Primær færdiggørelse (Faktiske)
1. august 2014
Studieafslutning (Faktiske)
1. august 2014
Datoer for studieregistrering
Først indsendt
30. oktober 2012
Først indsendt, der opfyldte QC-kriterier
30. oktober 2012
Først opslået (Skøn)
1. november 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. januar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. januar 2016
Sidst verificeret
1. januar 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PBRC 10040
- R01DK089051 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .