Child BehaviorNCT02091154
How Environmental Interventions Influence Behavior in School Lunchrooms
A study testing USDA Regulations, Marketing Kit and Smarter Lunchrooms Makeover (SLM) in people with Child Behavior and Adolescent Behavior, run by Cornell University at 1 site in United States.
Trial summary
The investigators hypothesize that the new United States Department of Agriculture (USDA) regulations for lunches served as part of the National School Lunch Program will decrease the percentage of enrolled students purchasing lunch, increase the percentage of children taking fruit and vegetables, decrease the… Read more about this study
- Who is it for?
- Ages 5 to 19 years
- Conditions the study is for
- Child Behavior, Adolescent Behavior, Health Behavior
- What is being tested?
- USDA Regulations, Marketing Kit and Smarter Lunchrooms Makeover (SLM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2012
- 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 5 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Public schools with any combination of grades K-12
Who cannot join
- No point of sale system in school
- Satellite school
- Feeder school
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Impact on Lunch Sales and Consumption of New School Lunch Guidelines and Behavioral Interventions in NYC Schools
The investigators hypothesize that the new United States Department of Agriculture (USDA) regulations for lunches served as part of the National School Lunch Program will decrease the percentage of enrolled students purchasing lunch, increase the percentage of children taking fruit and vegetables, decrease the percentage of fruit and vegetable servings being thrown away, and increase the total number of fruit and vegetable servings eaten.
The investigators also hypothesize that when the regulations are in force, simple behavioral interventions can counteract the potentially negative impact on lunch sales and consumption. In other words, implementing the regulations and behavioral interventions together, the percentage of enrolled students taking a school lunch will increase at least back to baseline levels, the percentage of children taking fruits and vegetables will increase, the percentage of fruit and vegetable servings wasted will decrease, and the total number of fruit and vegetable servings eaten will increase.
Read the detailed description
This study was conducted in 43 schools in the New York City (NYC) School district in the spring of 2012. The new regulations for school lunches were scheduled to roll out nationally in the fall of the same year, so this study was designed to provide an indication of the impact the new regulations would have.
In addition to the regulations, the investigators also tested additional behavioral interventions, in conjunction with the regulations, to determine how the behavioral interventions might offset, or magnify, the impacts of the regulations.
- Conditions
- Child Behavior, Adolescent Behavior, Health Behavior
- Being tested
- USDA Regulations, Marketing Kit, Smarter Lunchrooms Makeover (SLM)
- Keywords
- Food Intake Regulation, Fruit, Vegetable
- Medical subject headings
- Child Behavior, Adolescent Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USDA RegulationsBehavioural
Implement new USDA regulations assigned school cafeterias.
- Fruit or vegetable on every tray
- Meet requirements for vegetable varieties
- 50% of all grains must be whole grain
- Milk must be 1% or skim; flavored milk must be skim
Marketing KitBehavioural
This marketing tool kit is designed to encourage purchasing of school lunches. The marketing tool kit included the following components:
- 56''x72'' vinyl sign with the words "[school mascot] Cafe"
- 8.5''x11'' signs describing the foods offered on a specific day
- 2''x4'' signs used to name all foods. These were to be placed in a visible location near the corresponding food.
- Magnetic board displaying a tray onto which magnets shaped as food can be placed to show what foods were being offered during a specific lunch shift.
Smarter Lunchrooms Makeover (SLM)Behavioural
Implement three basic Smarter Lunchrooms techniques. It consists of the following components:
- Place fruit in an attractive bowl or serving dish and set on two places on the line. One of the places should be at or near the register.
- Give all vegetables descriptive names and write or type them on a 2''x4'' card. These cards should be visible and placed near the corresponding food.
- Make white milk the most prominent milk in the milk coolers by making it the most available milk and easiest to take.
| Study group | Role | What they receive |
|---|---|---|
| USDA Regulations Only | Experimental | Implement USDA Regulations in assigned school cafeterias during the intervention period. Receives: Behavioral: USDA Regulations |
| USDA Regulations and Marketing Kit | Experimental | Implement new USDA regulations in assigned schools along with the Marketing Kit during the intervention period. Receives: Behavioral: USDA Regulations; Behavioral: Marketing Kit |
| USDA Regulations and SLM | Experimental | Implement USDA Regulations and Smarter Lunchrooms Makeover in assigned schools during intervention period. Receives: Behavioral: USDA Regulations; Behavioral: Smarter Lunchrooms Makeover (SLM) |
| Control | No intervention | Schools assigned to this intervention made no changes to their lunchroom or menus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent fruit or vegetable waste by student
In the twelve schools, tray waste data were collected twice in April 2012 and once in May 2012. Results were generated and reported in September 2012.
Measured: Six months
Secondary outcomes (1)
Change in lunch sales
Lunch sales data were collected each school day in the 43 schools from March through May 2012. Results were generated and reported in September 2012.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
- Investigators
- Adam Brumberg, BA, Principal investigator, Cornell UniversityKathryn Hoy, RD, MFN, Principal investigator, Cornell UniversityDavid Just, PhD, Study chair, Cornell UniversityBrian Wansink, PhD, Study director, Cornell UniversityAndrew Hanks, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091154
- Sponsor's protocol ID
- 1202002824
- Status last verified
- Jan 2022
- First submitted
- 3 Mar 2014
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanks AS, Wansink B, Just DR. Reliability and accuracy of real-time visualization techniques for measuring school cafeteria tray waste: validating the quarter-waste method. J Acad Nutr Diet. 2014 Mar;114(3):470-474. doi: 10.1016/j.jand.2013.08.013. Epub 2013 Oct 14.
PubMed 24135053Hanks AS, Just DR, Wansink B. Smarter lunchrooms can address new school lunchroom guidelines and childhood obesity. J Pediatr. 2013 Apr;162(4):867-9. doi: 10.1016/j.jpeds.2012.12.031. Epub 2013 Feb 22.
PubMed 23434267Wansink B, Just DR, Hanks AS, Smith LE. Pre-sliced fruit in school cafeterias: children's selection and intake. Am J Prev Med. 2013 May;44(5):477-80. doi: 10.1016/j.amepre.2013.02.003.
PubMed 23597811Hanks AS, Just DR, Smith LE, Wansink B. Healthy convenience: nudging students toward healthier choices in the lunchroom. J Public Health (Oxf). 2012 Aug;34(3):370-6. doi: 10.1093/pubmed/fds003. Epub 2012 Jan 31.
PubMed 22294661
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact on Lunch Sales and Consumption of New School Lunch Guidelines and Behavioral Interventions in NYC Schools
- ClinicalTrials.gov ID
- NCT02091154
- Acronym / sponsor ID
- 1202002824
- Conditions
- Child Behavior, Adolescent Behavior, Health Behavior
- Keywords
- Food Intake Regulation, Fruit, Vegetable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 Mar 2014 (estimated)
- 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 investigators hypothesize that the new United States Department of Agriculture (USDA) regulations for lunches served as part of the National School Lunch Program will decrease the percentage of enrolled students purchasing lunch, increase the percentage of children taking fruit and vegetables, decrease the percentage of fruit and vegetable servings being thrown away, and increase the total number of fruit and vegetable servings eaten.
The investigators also hypothesize that when the regulations are in force, simple behavioral interventions can counteract the potentially negative impact on lunch sales and consumption. In other words, implementing the regulations and behavioral interventions together, the percentage of enrolled students taking a school lunch will increase at least back to baseline levels, the percentage of children taking fruits and vegetables will increase, the percentage of fruit and vegetable servings wasted will decrease, and the total number of fruit and vegetable servings eaten will increase.
Detailed description
This study was conducted in 43 schools in the New York City (NYC) School district in the spring of 2012. The new regulations for school lunches were scheduled to roll out nationally in the fall of the same year, so this study was designed to provide an indication of the impact the new regulations would have.
In addition to the regulations, the investigators also tested additional behavioral interventions, in conjunction with the regulations, to determine how the behavioral interventions might offset, or magnify, the impacts of the regulations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| USDA Regulations Only | Experimental | Behavioral: USDA RegulationsImplement USDA Regulations in assigned school cafeterias during the intervention period. |
| USDA Regulations and Marketing Kit | Experimental | Behavioral: USDA Regulations, Behavioral: Marketing KitImplement new USDA regulations in assigned schools along with the Marketing Kit during the intervention period. |
| USDA Regulations and SLM | Experimental | Behavioral: USDA Regulations, Behavioral: Smarter Lunchrooms Makeover (SLM)Implement USDA Regulations and Smarter Lunchrooms Makeover in assigned schools during intervention period. |
| Control | No intervention | –Schools assigned to this intervention made no changes to their lunchroom or menus. |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Public schools with any combination of grades K-12
Key exclusion criteria (3 listed)
- No point of sale system in school
- Satellite school
- Feeder school
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 |
|---|---|---|
| USDA RegulationsImplement new USDA regulations assigned school cafeterias. 1. Fruit or vegetable on every tray 2. Meet requirements for vegetable varieties 3. 50% of all grains must be whole grain 4. Milk must be 1% or skim; flavored milk must be skim | Behavioural | USDA Regulations Only, USDA Regulations and Marketing Kit, USDA Regulations and SLM |
| Marketing KitThis marketing tool kit is designed to encourage purchasing of school lunches. The marketing tool kit included the following components: 1. 56''x72'' vinyl sign with the words "[school mascot] Cafe" 2. 8.5''x11'' signs describing the foods offered on a specific day 3. 2''x4'' signs used to name all foods. These were to be placed in a visible location near the corresponding food. 4. Magnetic board displaying a tray onto which magnets shaped as food can be placed to show what foods were being offered during a specific lunch shift. | Behavioural | USDA Regulations and Marketing Kit |
| Smarter Lunchrooms Makeover (SLM)Implement three basic Smarter Lunchrooms techniques. It consists of the following components: 1. Place fruit in an attractive bowl or serving dish and set on two places on the line. One of the places should be at or near the register. 2. Give all vegetables descriptive names and write or type them on a 2''x4'' card. These cards should be visible and placed near the corresponding food. 3. Make white milk the most prominent milk in the milk coolers by making it the most available milk and easiest to take. | Behavioural | USDA Regulations and SLM |
Primary outcome
Change in percent fruit or vegetable waste by student
Time frame: Six months
In the twelve schools, tray waste data were collected twice in April 2012 and once in May 2012. Results were generated and reported in September 2012.
1 secondary outcome
Change in lunch sales
Time frame: Six months
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 Feb 2022.
- Background: PubMed 24135053Hanks AS, Wansink B, Just DR. Reliability and accuracy of real-time visualization techniques for measuring school cafeteria tray waste: validating the quarter-waste method. J Acad Nutr Diet. 2014 Mar;114(3):470-474. doi: 10.1016/j.jand.2013.08.013. Epub 2013 Oct 14.
- Background: PubMed 23434267Hanks AS, Just DR, Wansink B. Smarter lunchrooms can address new school lunchroom guidelines and childhood obesity. J Pediatr. 2013 Apr;162(4):867-9. doi: 10.1016/j.jpeds.2012.12.031. Epub 2013 Feb 22.
- Background: PubMed 23597811Wansink B, Just DR, Hanks AS, Smith LE. Pre-sliced fruit in school cafeterias: children's selection and intake. Am J Prev Med. 2013 May;44(5):477-80. doi: 10.1016/j.amepre.2013.02.003.
- Background: PubMed 22294661Hanks AS, Just DR, Smith LE, Wansink B. Healthy convenience: nudging students toward healthier choices in the lunchroom. J Public Health (Oxf). 2012 Aug;34(3):370-6. doi: 10.1093/pubmed/fds003. Epub 2012 Jan 31.
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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.
Adam Brumberg, BA principal investigator
Cornell University
Kathryn Hoy, RD, MFN principal investigator
Cornell University
David Just, PhD study chair
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USDA Regulations, Marketing Kit and Smarter Lunchrooms Makeover (SLM) in people with Child Behavior and Adolescent Behavior, run by Cornell University at 1 site 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 3 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 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in percent fruit or vegetable waste by student (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091154, which also lists 4 linked publications.
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 Feb 2022.