- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01262768
Efficacy of Portion Size Measurement Aids (PSMA)
19. februar 2014 opdateret af: Geoff Ball, University of Alberta
Exploring the Accuracy and Acceptability of Portion Size Measurement Aids in Parents of Overweight Children
Portion size measurement aids (PSMAs) are tools that facilitate the estimation of food servings.
The objectives of this study are to determine (a) if food portion size estimation accuracy differs when using a two dimensional (2D) PSMA (actual-size photos called Portion Size Cards) compared to a 3D PSMA (Portion Size Kit) and (b) whether differences exist in the short-term usefulness of and satisfaction with these PSMAs in a sample of parents of overweight children and youth.
We hypothesize that the group that receives the 3D PSMAs will be more accurate in food portion size estimation and will be more satisfied with the tool compared to the group that receives the 2D PSMAs.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Forty primary caregivers of overweight children and youth attending the Pediatric Centre for Weight and Health (Edmonton, AB) will be recruited.
Participants will be randomly assigned to one of the two groups (2D PSMAs versus 3D PSMAs).
After a brief explanation of the respective tool, participants will estimate the volumes of pre-measured rubber food portion models on a test plate.
Participants will then be given the 2D or 3D PSMAs to take home with them to use in the real-world.
After 2-4 weeks, participants will be telephoned by the research team to complete a brief survey to evaluate their usefulness of and satisfaction with the 2D or 3D PSMAs at home.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alberta
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Edmonton, Alberta, Canada, T6K 0L4
- Pediatric Centre for Weight and Health- Edmonton General Continuing Care Centre
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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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participants must be primary caregivers of children or youth attending a clinical appointment for weight management (clients must have a BMI greater or equal to the 85th percentile at this clinic)
- Participants must be literate and fluent in English
Exclusion Criteria:
- Any participant who does not meet the above criteria
- Participants must not have had any previous education or resources on food portion sizes at this clinic
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 2D Portion Size Measurment Aids (PSMAs)
The 2D PSMAs are life-size photographs of the 3D PSMAs.
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Subjects are randomly assigned to receive either 2D or 3D PSMAs to examine accuracy, acceptability and usefulness of the models.
Both groups receive brief instructions on the use of the respective PSMAs, complete an accuracy estimation task, and are given the 2D or 3D PSMAs to take home with them to use for 2-4 weeks, after which the researchers telephone parents to complete a brief satisfaction and usefulness survey.
Andre navne:
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Eksperimentel: 3D Portion Size Measurement Aids (PSMAs)
The 3D PSMAs include foam rubber replicas of a golf ball, a hockey puck, a tennis ball and a baseball.
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Subjects are randomly assigned to receive either 2D or 3D PSMAs to examine accuracy, acceptability and usefulness of the models.
Both groups receive brief instructions on the use of the respective PSMAs, complete an accuracy estimation task, and are given the 2D or 3D PSMAs to take home with them to use for 2-4 weeks, after which the researchers telephone parents to complete a brief satisfaction and usefulness survey.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Accuracy of food portion size estimation
Tidsramme: At the time of subject interview (single time point)
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During the initial interview, the subject receives a brief description of the task and is shown pre-estimated rubber food models.
The subject then estimates the portion sizes (volumes) of the rubber food models using either 2D or 3D PSMAs.
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At the time of subject interview (single time point)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Acceptability (satisfaction and usefulness) of 2D and 3D PSMAs
Tidsramme: 2-4 weeks following the accuracy assessment
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After the intial interview, subjects are given either 2D or 3D PSMAs to take home with them to use in a real-world setting.
After 2-4 weeks, the researcher team contacts the subjects to complete a brief telephone interview to determine parental satisfaction and usefulness regarding the 2D or 3D PSMAs.
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2-4 weeks following the accuracy assessment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Geoff DC Ball, PhD, RD, Department of Pediatrics, University of Alberta; Director, Pediatric Centre for Weight and Health
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. april 2010
Primær færdiggørelse (Faktiske)
1. september 2013
Studieafslutning (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først indsendt
16. december 2010
Først indsendt, der opfyldte QC-kriterier
16. december 2010
Først opslået (Skøn)
17. december 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. februar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. februar 2014
Sidst verificeret
1. februar 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 00010835
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 .