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Nudging for Behavior Change in School Cafeterias

6. november 2019 opdateret af: Andrew Hanks, Ohio State University

Measuring the Long-Term Impact of Behavioral Interventions in Middle School Cafeterias

The main purpose of this research is to look at a school lunchroom intervention that is known to improve fruit, vegetable, and milk consumption and see how it changes in the long run and if it affects the child's behavior permanently. The intervention will include the giving the vegetables descriptive names, moving the fruit to right next to the register and in attractive bowls, and increasing the amount of white milk served by 10%. The main forms of analyzing these results are through food preparation records, lunch sales records, and tray waste records. The first focus of this study is to see if there is a specific point in an intervention when improvement stops and therefore the intervention needs to be updated. This procedure involves looking at five similar middle schools with this same intervention over a 15 week period. The time of intervention implementation will vary by three week intervals, so the first will start the first week of school, the next school will start after three weeks of school, the next will start after six weeks of school, and the next will start after nine weeks of school, and the last will be a control school where there will be no intervention implementation. These intervals will help eliminate bias dealing with the beginning of the year excitement and seasonal effects. Food preparation records and lunch sales records will be collected from the school for the 15 week period. Tray waste will be recorded by having 200 randomly selected trays measured and collected twice a week over the 15 week period. This focus will help schools manage when they need to change their intervention so that improvements will not stop. The second focus of this study is to see if the children's improvement is kept when the intervention has stopped. This procedure will involve looking at a similar school to the other 5 schools. But unlike the other schools, this one will have the first 5 weeks without the intervention, then 5 weeks with the intervention, and then another 5 weeks without the intervention. Food preparation records and lunch sales records will be collected from the school for the 15 week period. Tray waste will be recorded by having 200 randomly selected trays measured and collected twice a week over the 15 week period. This second focus will help identify how effective this intervention is in permanently changing dietary habits.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
3000

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43203
        • Champion Middle School
      • Columbus, Ohio, Forenede Stater, 43204
        • Hilltonia Middle School
      • Columbus, Ohio, Forenede Stater, 43207
        • Buckeye Middle School
      • Columbus, Ohio, Forenede Stater, 43219
        • Mifflin Middle School
      • Columbus, Ohio, Forenede Stater, 43224
        • Medina Middle School
      • Columbus, Ohio, Forenede Stater, 43227
        • Johnson Park Middle School

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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

10 år til 15 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • This research focused on food choices of middle school students, grades 6-8, which generally range in ages 11-14. In addition, since we are interested in learning about the types of cafeteria foods children select and what they throw away, we focus on students who receive a school lunch meal.

Exclusion Criteria:

  • We exclude students who do not receive a school lunch meal.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Ingen indgriben: Control
In this school, we collected data throughout the entire study without implementing any intervention.
Eksperimentel: 5-week Intervention with Post-intervention Data Collection
In this school, we collected baseline data for 5 weeks, implemented the intervention for five weeks, then removed the intervention and collected post-intervention data for five weeks.
Adfærdsmæssigt: Basic School Lunchroom Nudges
The intervention consists of three components: 1) serving fresh fruit in attractive bowls in at least two locations on the lunch line; 2) providing descriptive names for the vegetables; and 3) increasing amount of plain milk availability by 10% and placing it in front of the chocolate milk. For the vegetable naming intervention, researchers first developed, printed, and laminated descriptive vegetable name cards (2"x4"). Some examples included "Savory Collard Greens," and "[School Mascot] Salad." Cafeteria staff affixed name cards to the serving line sneeze-guards in front of the vegetables for the day. For the fruit intervention, we purchased and delivered two ceramic bowls to the intervention school. The cafeteria staff filled the bowls and put them in different locations on the lunch line. For the milk intervention, cafeteria staff increased the amount of plain milk available by 10% and placed plain in front of chocolate milk in the coolers.
Eksperimentel: Implement intervention for 15 weeks
In this school, we implemented the intervention on January 11, 2016, the day the study began.
Adfærdsmæssigt: Basic School Lunchroom Nudges
The intervention consists of three components: 1) serving fresh fruit in attractive bowls in at least two locations on the lunch line; 2) providing descriptive names for the vegetables; and 3) increasing amount of plain milk availability by 10% and placing it in front of the chocolate milk. For the vegetable naming intervention, researchers first developed, printed, and laminated descriptive vegetable name cards (2"x4"). Some examples included "Savory Collard Greens," and "[School Mascot] Salad." Cafeteria staff affixed name cards to the serving line sneeze-guards in front of the vegetables for the day. For the fruit intervention, we purchased and delivered two ceramic bowls to the intervention school. The cafeteria staff filled the bowls and put them in different locations on the lunch line. For the milk intervention, cafeteria staff increased the amount of plain milk available by 10% and placed plain in front of chocolate milk in the coolers.
Eksperimentel: Implement intervention for 12 weeks
In this school, we collected baseline data for three weeks and then implemented the intervention for the remaining twelve weeks.
Adfærdsmæssigt: Basic School Lunchroom Nudges
The intervention consists of three components: 1) serving fresh fruit in attractive bowls in at least two locations on the lunch line; 2) providing descriptive names for the vegetables; and 3) increasing amount of plain milk availability by 10% and placing it in front of the chocolate milk. For the vegetable naming intervention, researchers first developed, printed, and laminated descriptive vegetable name cards (2"x4"). Some examples included "Savory Collard Greens," and "[School Mascot] Salad." Cafeteria staff affixed name cards to the serving line sneeze-guards in front of the vegetables for the day. For the fruit intervention, we purchased and delivered two ceramic bowls to the intervention school. The cafeteria staff filled the bowls and put them in different locations on the lunch line. For the milk intervention, cafeteria staff increased the amount of plain milk available by 10% and placed plain in front of chocolate milk in the coolers.
Eksperimentel: Implement intervention for 9 weeks
In this school, we collected baseline data for six weeks and then implemented the intervention for the remaining nine weeks.
Adfærdsmæssigt: Basic School Lunchroom Nudges
The intervention consists of three components: 1) serving fresh fruit in attractive bowls in at least two locations on the lunch line; 2) providing descriptive names for the vegetables; and 3) increasing amount of plain milk availability by 10% and placing it in front of the chocolate milk. For the vegetable naming intervention, researchers first developed, printed, and laminated descriptive vegetable name cards (2"x4"). Some examples included "Savory Collard Greens," and "[School Mascot] Salad." Cafeteria staff affixed name cards to the serving line sneeze-guards in front of the vegetables for the day. For the fruit intervention, we purchased and delivered two ceramic bowls to the intervention school. The cafeteria staff filled the bowls and put them in different locations on the lunch line. For the milk intervention, cafeteria staff increased the amount of plain milk available by 10% and placed plain in front of chocolate milk in the coolers.
Eksperimentel: Implement intervention for 6 weeks
In this school, we collected baseline data for nine weeks and then implemented the intervention for the remaining six weeks.
Adfærdsmæssigt: Basic School Lunchroom Nudges
The intervention consists of three components: 1) serving fresh fruit in attractive bowls in at least two locations on the lunch line; 2) providing descriptive names for the vegetables; and 3) increasing amount of plain milk availability by 10% and placing it in front of the chocolate milk. For the vegetable naming intervention, researchers first developed, printed, and laminated descriptive vegetable name cards (2"x4"). Some examples included "Savory Collard Greens," and "[School Mascot] Salad." Cafeteria staff affixed name cards to the serving line sneeze-guards in front of the vegetables for the day. For the fruit intervention, we purchased and delivered two ceramic bowls to the intervention school. The cafeteria staff filled the bowls and put them in different locations on the lunch line. For the milk intervention, cafeteria staff increased the amount of plain milk available by 10% and placed plain in front of chocolate milk in the coolers.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of students that took a serving of fruit
Tidsramme: 30 days
To determine whether or not a student took a serving of fruit, we will rely on tray waste records that we collected twice a week (repeated measures) for the duration of the study. Based on these records, if a student selected a serving of fruit, she will receive a value of one. Otherwise, she will receive a value of zero. We will use this binary measure to estimate the proportion of students who took a serving of fruit.
30 days
Percentage of students that took a serving of vegetables
Tidsramme: 30 days
To determine whether or not a student took a serving of vegetables, we will rely on tray waste records that we collected twice a week (repeated measures) for the duration of the study. Based on these records, if a student selected a serving of vegetables, she will receive a value of one. Otherwise, she will receive a value of zero. We will use this binary measure to estimate the proportion of students who took a serving of vegetables.
30 days
Percentage of students that took a carton of white milk (one pint)
Tidsramme: 30 days
To determine whether or not a student took a carton of white milk, we will rely on tray waste records that we collected twice a week (repeated measures) for the duration of the study. Based on these records, if a student selected a carton of white milk, she will receive a value of one. Otherwise, she will receive a value of zero. We will use this binary measure to estimate the proportion of students who took a carton of white milk.
30 days
Percentage of students that took a serving of flavored milk (one pint)
Tidsramme: 30 days
To determine whether or not a student took a carton of flavored milk, we will rely on tray waste records that we collected twice a week (repeated measures) for the duration of the study. Based on these records, if a student selected a carton of flavored milk, she will receive a value of one. Otherwise, she will receive a value of zero. We will use this binary measure to estimate the proportion of students who took a carton of flavored milk.
30 days
Percentage of students that took an entree
Tidsramme: 30 days
To determine whether or not a student took an entree, we will rely on tray waste records that we collected twice a week (repeated measures) for the duration of the study. Based on these records, if a student selected an entree, she will receive a value of one. Otherwise, she will receive a value of zero. We will use this binary measure to estimate the proportion of students who took an entree.
30 days
Fraction of fruit serving wasted by the student
Tidsramme: 30 days
The tray waste records our researchers collected twice a week (repeated measures) for the duration of the study indicate how much -- 0, one-quarter, one-half, three-quarters, all -- of the fruit serving a student threw away. We will use this measure to estimate the percentage of fruit servings students wasted.
30 days
Fraction of vegetable serving wasted by the student
Tidsramme: 30 days
The tray waste records our researchers collected twice a week (repeated measures) for the duration of the study indicate how much -- 0, one-quarter, one-half, three-quarters, all -- of the vegetable serving a student threw away. We will use this measure to estimate the percentage of vegetable servings students wasted.
30 days
Fraction of white milk wasted by the student
Tidsramme: 30 days
The tray waste records our researchers collected twice a week (repeated measures) for the duration of the study indicate how much -- 0, one-quarter, one-half, three-quarters, all -- of the serving of white milk (one pint) a student threw away. We will use this measure to estimate the percentage of white milk servings students wasted.
30 days
Fraction of flavored milk wasted by the student
Tidsramme: 30 days
The tray waste records our researchers collected twice a week (repeated measures) for the duration of the study indicate how much -- 0, one-quarter, one-half, three-quarters, all -- of the serving of flavored milk (one pint) a student threw away. We will use this measure to estimate the percentage of flavored milk servings students wasted.
30 days
Fraction of entree wasted by the student
Tidsramme: 30 days
The tray waste records our researchers collected twice a week (repeated measures) for the duration of the study indicate how much -- 0, one-quarter, one-half, three-quarters, all -- of the entree serving a student threw away. We will use this measure to estimate the percentage of entree servings students wasted.
30 days
Proportion of prepared fruit servings that students took
Tidsramme: 75 days
Cafeterias in the study provided us with food production records that provide daily records of the number of fruit servings cafeteria staff prepared and the number of fruit servings students took. To calculate the proportion of prepared fruit servings taken by students we will divide the number of servings students took by the total number of servings prepared.
75 days
Proportion of prepared vegetable servings that students took
Tidsramme: 75 days
Cafeterias in the study provided us with food production records that provide daily records of the number of vegetable servings cafeteria staff prepared and the number of vegetable servings students took. To calculate the proportion of prepared vegetable servings taken by students we will divide the number of servings students took by the total number of servings prepared.
75 days
Proportion of prepared entree servings that students took
Tidsramme: 75 days
Cafeterias in the study provided us with food production records that provide daily records of the number of entree servings cafeteria staff prepared and the number of entree servings students took. To calculate the proportion of prepared entree servings taken by students we will divide the number of servings students took by the total number of servings prepared.
75 days
Proportion of white milk cartons taken
Tidsramme: 75 days
Cafeterias in the study provided us with food production records that provide daily records of the number of white milk cartons made available and the number of white milk cartons students took. To calculate the proportion of white milk cartons taken by students we will divide the number of servings students took by the total number of servings prepared.
75 days
Proportion of flavored milk cartons taken
Tidsramme: 75 days
Cafeterias in the study provided us with food production records that provide daily records of the number of flavored milk cartons made available and the number of flavored milk cartons students took. To calculate the proportion of flavored milk cartons taken by students we will divide the number of servings students took by the total number of servings prepared.
75 days
Percentage of total students that took a fruit serving
Tidsramme: 75 days
Cafeterias in the study provided us with food production records that provide daily records of the number of fruit servings prepared and the total number of students who received a school lunch. To calculate the percentage of students who took a fruit serving we will divide the number of servings students took by the total number of students who received lunch.
75 days
Percentage of total students that took a vegetable serving
Tidsramme: 75 days
Cafeterias in the study provided us with food production records that provide daily records of the number of vegetable servings prepared and the total number of students who received a school lunch. To calculate the percentage of students who took a vegetable serving we will divide the number of servings students took by the total number of students who received lunch.
75 days
Percentage of total students that took an entree serving
Tidsramme: 75 days
Cafeterias in the study provided us with food production records that provide daily records of the number of entree servings prepared and the total number of students who received a school lunch. To calculate the percentage of students who took an entree serving we will divide the number of servings students took by the total number of students who received lunch.
75 days
Percentage of total students that took a carton of white milk
Tidsramme: 75 days
Cafeterias in the study provided us with food production records that provide daily records of the number of white milk cartons made available the total number of students who received a school lunch. To calculate the percentage of students who took a carton of white milk we will divide the number of servings students took by the total number of students who received lunch.
75 days
Percentage of total students that took a carton of flavored milk
Tidsramme: 75 days
Cafeterias in the study provided us with food production records that provide daily records of the number of flavored milk cartons made available the total number of students who received a school lunch. To calculate the percentage of students who took a carton of flavored milk we will divide the number of servings students took by the total number of students who received lunch.
75 days
Percentage of fidelity assessments that returned positive marks
Tidsramme: 36 days
Throughout the study, researchers conducted fidelity assessments to make sure the schools maintained the interventions. These process control measures are the ratio of successful fidelity checks to the total number. Researchers conducted these assessments during each day they collected tray waste measures and during a randomly selected non-tray waste collection date once a month.
36 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Ohio State University

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Cornell University
Columbus City School District

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Andrew S Hanks, PhD, Ohio State University
  • Studieleder: Haleigh Gaines, MS,RD, Ohio State University

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 (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
11. januar 2016

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
27. april 2016

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
29. april 2016

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
29. oktober 2019

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
6. november 2019

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
7. november 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
7. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
6. november 2019

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 2016B0004
  • 2019B0480 (Anden identifikator: Ohio State University)
  • 62140-10509 (Andet bevillings-/finansieringsnummer: Cornell University)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

We agree to share the study data with researchers who request access. While we will not publicly post the data, we will provide them through an electronic link. None of the data contain unique identifiers.

IPD-delingstidsramme

Data are available as of October 29, 2019 and will be available until December 31, 2020.

IPD-delingsadgangskriterier

Those interested in acquiring the data can contact Dr. Andrew Hanks at hanks.46@osu.edu.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

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