Nudging for Behavior Change in School Cafeterias

November 6, 2019 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
In this school, we collected data throughout the entire study without implementing any intervention.
Experimental: 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.
Behavioral: 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.
Experimental: Implement intervention for 15 weeks
In this school, we implemented the intervention on January 11, 2016, the day the study began.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of students that took a serving of fruit
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cornell University
Columbus City School District

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew S Hanks, PhD, Ohio State University
  • Study Director: Haleigh Gaines, MS,RD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016B0004
  • 2019B0480 (Other Identifier: Ohio State University)
  • 62140-10509 (Other Grant/Funding Number: Cornell University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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