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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04156542
Other study ID # 2016B0004
Secondary ID 2019B048062140-1
Status Completed
Phase N/A
First received
Last updated
Start date January 11, 2016
Est. completion date April 29, 2016

Study information

Verified date November 2019
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3000
Est. completion date April 29, 2016
Est. primary completion date April 27, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 15 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Buckeye Middle School Columbus Ohio
United States Champion Middle School Columbus Ohio
United States Hilltonia Middle School Columbus Ohio
United States Johnson Park Middle School Columbus Ohio
United States Medina Middle School Columbus Ohio
United States Mifflin Middle School Columbus Ohio

Sponsors (3)

Lead Sponsor Collaborator
Ohio State University Columbus City School District, Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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