- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04156542
Nudging for Behavior Change in School Cafeterias
6. listopadu 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
3000
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ohio
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Columbus, Ohio, Spojené státy, 43203
- Champion Middle School
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Columbus, Ohio, Spojené státy, 43204
- Hilltonia Middle School
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Columbus, Ohio, Spojené státy, 43207
- Buckeye Middle School
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Columbus, Ohio, Spojené státy, 43219
- Mifflin Middle School
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Columbus, Ohio, Spojené státy, 43224
- Medina Middle School
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Columbus, Ohio, Spojené státy, 43227
- Johnson Park Middle School
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
10 let až 15 let (Dítě)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Control
In this school, we collected data throughout the entire study without implementing any intervention.
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Experimentální: 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.
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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.
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Experimentální: Implement intervention for 15 weeks
In this school, we implemented the intervention on January 11, 2016, the day the study began.
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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.
|
|
Experimentální: 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.
|
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.
|
|
Experimentální: 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.
|
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.
|
|
Experimentální: 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.
|
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of students that took a serving of fruit
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
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Percentage of students that took an entree
Časové okno: 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
|
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Fraction of fruit serving wasted by the student
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Proportion of prepared vegetable servings that students took
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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36 days
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Andrew S Hanks, PhD, Ohio State University
- Ředitel studie: Haleigh Gaines, MS,RD, Ohio State University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
11. ledna 2016
Primární dokončení (Aktuální)
27. dubna 2016
Dokončení studie (Aktuální)
29. dubna 2016
Termíny zápisu do studia
První předloženo
29. října 2019
První předloženo, které splnilo kritéria kontroly kvality
6. listopadu 2019
První zveřejněno (Aktuální)
7. listopadu 2019
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
7. listopadu 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
6. listopadu 2019
Naposledy ověřeno
1. listopadu 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2016B0004
- 2019B0480 (Jiný identifikátor: Ohio State University)
- 62140-10509 (Jiné číslo grantu/financování: Cornell University)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
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.
Časový rámec sdílení IPD
Data are available as of October 29, 2019 and will be available until December 31, 2020.
Kritéria přístupu pro sdílení IPD
Those interested in acquiring the data can contact Dr. Andrew Hanks at hanks.46@osu.edu.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .