NCT04156542

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2016

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2016

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

October 29, 2019

Last Update Submit

November 6, 2019

Conditions

Keywords

Behavioral nudgesFood environmentChoice architectureLasting behavior changeChild nutritionNational School Lunch Program

Outcome Measures

Primary Outcomes (21)

  • Percentage of students that took a serving of fruit

    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

    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)

    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)

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (6)

Control

NO INTERVENTION

In this school, we collected data throughout the entire study without implementing any intervention.

5-week Intervention with Post-intervention Data Collection

EXPERIMENTAL

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

Implement intervention for 15 weeks

EXPERIMENTAL

In this school, we implemented the intervention on January 11, 2016, the day the study began.

Behavioral: Basic School Lunchroom Nudges

Implement intervention for 12 weeks

EXPERIMENTAL

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

Implement intervention for 9 weeks

EXPERIMENTAL

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

Implement intervention for 6 weeks

EXPERIMENTAL

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

Interventions

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.

5-week Intervention with Post-intervention Data CollectionImplement intervention for 12 weeksImplement intervention for 15 weeksImplement intervention for 6 weeksImplement intervention for 9 weeks

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Champion Middle School

Columbus, Ohio, 43203, United States

Location

Hilltonia Middle School

Columbus, Ohio, 43204, United States

Location

Buckeye Middle School

Columbus, Ohio, 43207, United States

Location

Mifflin Middle School

Columbus, Ohio, 43219, United States

Location

Medina Middle School

Columbus, Ohio, 43224, United States

Location

Johnson Park Middle School

Columbus, Ohio, 43227, United States

Location

MeSH Terms

Conditions

Child BehaviorFood Preferences

Condition Hierarchy (Ancestors)

BehaviorFeeding Behavior

Study Officials

  • Andrew S Hanks, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR
  • Haleigh Gaines, MS,RD

    Ohio State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Researchers entered school cafeterias to collect student tray waste data. When students asked why the researchers were there, researchers indicated their purpose was to learn more about the National School Lunch Program.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: We randomly assigned the six participating schools to either be a control school (N=1) or a treatment school (N=5). Each of the treatment schools administered a single intervention, but at different times. In our fifteen-week study, one school implemented the intervention for five weeks after five weeks of baseline data collection. Once this school completed the five weeks with the treatment, it removed the intervention and collected five more weeks of post-intervention data. In the other four schools, we staggered intervention implementation. The first school implemented the intervention on the first day of the study. The next school implemented the intervention after three weeks of collecting baseline data. The next school implemented the intervention after six weeks of collecting baseline data. Lastly, the final school implemented the intervention after nine weeks of collecting baseline data.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 29, 2019

First Posted

November 7, 2019

Study Start

January 11, 2016

Primary Completion

April 27, 2016

Study Completion

April 29, 2016

Last Updated

November 7, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Data are available as of October 29, 2019 and will be available until December 31, 2020.
Access Criteria
Those interested in acquiring the data can contact Dr. Andrew Hanks at hanks.46@osu.edu.

Locations