- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04156542
Nudging for Behavior Change in School Cafeterias
6 novembre 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
3000
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Ohio
-
Columbus, Ohio, États-Unis, 43203
- Champion Middle School
-
Columbus, Ohio, États-Unis, 43204
- Hilltonia Middle School
-
Columbus, Ohio, États-Unis, 43207
- Buckeye Middle School
-
Columbus, Ohio, États-Unis, 43219
- Mifflin Middle School
-
Columbus, Ohio, États-Unis, 43224
- Medina Middle School
-
Columbus, Ohio, États-Unis, 43227
- Johnson Park Middle School
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
10 ans à 15 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control
In this school, we collected data throughout the entire study without implementing any intervention.
|
|
|
Expérimental: 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.
|
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.
|
|
Expérimental: Implement intervention for 15 weeks
In this school, we implemented the intervention on January 11, 2016, the day the study began.
|
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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of students that took a serving of fruit
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Andrew S Hanks, PhD, Ohio State University
- Directeur d'études: Haleigh Gaines, MS,RD, Ohio State University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
11 janvier 2016
Achèvement primaire (Réel)
27 avril 2016
Achèvement de l'étude (Réel)
29 avril 2016
Dates d'inscription aux études
Première soumission
29 octobre 2019
Première soumission répondant aux critères de contrôle qualité
6 novembre 2019
Première publication (Réel)
7 novembre 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 novembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 novembre 2019
Dernière vérification
1 novembre 2019
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2016B0004
- 2019B0480 (Autre identifiant: Ohio State University)
- 62140-10509 (Autre subvention/numéro de financement: Cornell University)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage IPD
Data are available as of October 29, 2019 and will be available until December 31, 2020.
Critères d'accès au partage IPD
Those interested in acquiring the data can contact Dr. Andrew Hanks at hanks.46@osu.edu.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .