Clinical trial NCT04156542: Nudging for Behavior Change in School Cafeterias
Official title: Measuring the Long-Term Impact of Behavioral Interventions in Middle School Cafeterias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Child
Food Selection
Keywords: Behavioral nudges
Food environment
Choice architecture
Lasting behavior change
Child nutrition
National School Lunch Program
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Cornell University
name: Columbus City School District
First posted: 2019-11-07
Enrollment: 3000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of students that took a serving of fruit
timeFrame: 30 days
measure: Percentage of students that took a serving of vegetables
timeFrame: 30 days
measure: Percentage of students that took a carton of white milk (one pint)
timeFrame: 30 days
measure: Percentage of students that took a serving of flavored milk (one pint)
timeFrame: 30 days
measure: Percentage of students that took an entree
timeFrame: 30 days
measure: Fraction of fruit serving wasted by the student
timeFrame: 30 days
measure: Fraction of vegetable serving wasted by the student
timeFrame: 30 days
measure: Fraction of white milk wasted by the student
timeFrame: 30 days
measure: Fraction of flavored milk wasted by the student
timeFrame: 30 days
measure: Fraction of entree wasted by the student
timeFrame: 30 days
measure: Proportion of prepared fruit servings that students took
timeFrame: 75 days
measure: Proportion of prepared vegetable servings that students took
timeFrame: 75 days
measure: Proportion of prepared entree servings that students took
timeFrame: 75 days
measure: Proportion of white milk cartons taken
timeFrame: 75 days
measure: Proportion of flavored milk cartons taken
timeFrame: 75 days
measure: Percentage of total students that took a fruit serving
timeFrame: 75 days
measure: Percentage of total students that took a vegetable serving
timeFrame: 75 days
measure: Percentage of total students that took an entree serving
timeFrame: 75 days
measure: Percentage of total students that took a carton of white milk
timeFrame: 75 days
measure: Percentage of total students that took a carton of flavored milk
timeFrame: 75 days
measure: Percentage of fidelity assessments that returned positive marks
timeFrame: 36 days
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Champion Middle School
state: Ohio
city: Columbus
country: United States
facility: Hilltonia Middle School
state: Ohio
city: Columbus
country: United States
facility: Buckeye Middle School
state: Ohio
city: Columbus
country: United States
facility: Mifflin Middle School
state: Ohio
city: Columbus
country: United States
facility: Medina Middle School
state: Ohio
city: Columbus
country: United States
facility: Johnson Park Middle School
state: Ohio
Study officials:
affiliation: Ohio State University
name: Andrew S Hanks, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Haleigh Gaines, MS,RD
role: STUDY_DIRECTOR
References: