Behavior, ChildNCT04156542
Nudging for Behavior Change in School Cafeterias
A study testing Basic School Lunchroom Nudges in people with Behavior, Child and Food Selection, run by Ohio State University at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child, Food Selection
- What is being tested?
- Basic School Lunchroom Nudges
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Jan 2016to 29 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- We exclude students who do not receive a school lunch meal.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Champion Middle School
Columbus, Ohio, 43203
Hilltonia Middle School
Columbus, Ohio, 43204
Buckeye Middle School
Columbus, Ohio, 43207
Mifflin Middle School
Columbus, Ohio, 43219
Medina Middle School
Columbus, Ohio, 43224
Johnson Park Middle School
Columbus, Ohio, 43227
About this study
Official title: 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.
- Conditions
- Behavior, Child, Food Selection
- Being tested
- Basic School Lunchroom Nudges
- Keywords
- Behavioral nudges, Food environment, Choice architecture, Lasting behavior change, Child nutrition, National School Lunch Program
- Medical subject headings
- Child Behavior, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic School Lunchroom NudgesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Basic School Lunchroom Nudges |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start11 Jan 2016
- Primary completion27 Apr 2016
- Study completion29 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, ChildStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Columbus City School District
- Responsible party
- Principal investigator, Andrew Hanks, Ohio State University
- Investigators
- Andrew S Hanks, PhD, Principal investigator, Ohio State UniversityHaleigh Gaines, MS,RD, Study director, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156542
- Sponsor's protocol ID
- 2016B0004
- Other IDs
- 2019B0480, 62140-10509
- Status last verified
- Nov 2019
- First submitted
- 29 Oct 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Long-Term Impact of Behavioral Interventions in Middle School Cafeterias
- ClinicalTrials.gov ID
- NCT04156542
- Acronym / sponsor ID
- 2016B0004
- Conditions
- Behavior, Child, Food Selection
- Keywords
- Behavioral nudges, Food environment, Choice architecture, Lasting behavior change, Child nutrition, National School Lunch Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Cornell University, Columbus City School District
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 27 Apr 2016 (actual)
- Study completion
- 29 Apr 2016 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Basic School Lunchroom NudgesIn 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. |
| Implement intervention for 15 weeks | Experimental | Behavioral: Basic School Lunchroom NudgesIn this school, we implemented the intervention on January 11, 2016, the day the study began. |
| Implement intervention for 12 weeks | Experimental | Behavioral: Basic School Lunchroom NudgesIn this school, we collected baseline data for three weeks and then implemented the intervention for the remaining twelve weeks. |
| Implement intervention for 9 weeks | Experimental | Behavioral: Basic School Lunchroom NudgesIn this school, we collected baseline data for six weeks and then implemented the intervention for the remaining nine weeks. |
| Implement intervention for 6 weeks | Experimental | Behavioral: Basic School Lunchroom NudgesIn this school, we collected baseline data for nine weeks and then implemented the intervention for the remaining six weeks. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- We exclude students who do not receive a school lunch meal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic School Lunchroom NudgesThe 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. | Behavioural | 5-week Intervention with Post-intervention Data Collection, Implement intervention for 12 weeks, Implement intervention for 15 weeks, Implement intervention for 6 weeks, Implement intervention for 9 weeks |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew S Hanks, PhD principal investigator
Ohio State University
Haleigh Gaines, MS,RD study director
Ohio State University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic School Lunchroom Nudges in people with Behavior, Child and Food Selection, run by Ohio State University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of students that took a serving of fruit (time frame: 30 days). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.