MealsMEALSNCT02309840
The Modifying Eating and Lifestyles at School Study
A study testing choice architecture and Chef-enhanced meals in people with Meals and Food Habits, run by Harvard School of Public Health (HSPH).
Trial summary
The purpose of this study is to examine the impact of introducing healthier, chef-enhanced foods and/or environmental modifications (choice architecture) on selection and consumption of school foods among elementary and middle school students. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Meals, Food Habits
- What is being tested?
- choice architecture and Chef-enhanced meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,873 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jun 2014
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students in grades 1-8 attending a participating school and receiving a school meal on a study day
Who cannot join
- Bringing a lunch from home on a study day or not eating lunch in the cafeteria on a study day
About this study
Official title: The Modifying Eating and Lifestyles at School (MEALS) Study
The purpose of this study is to examine the impact of introducing healthier, chef-enhanced foods and/or environmental modifications (choice architecture) on selection and consumption of school foods among elementary and middle school students.
Read the detailed description
Project Modifying Eating and Lifestyles at School (MEALS) was a school-based study developed by the nonprofit organization Project Bread (www.ProjectBread.org) and the Harvard School of Public Health. Project Bread hired a professional chef to work with several schools in a low-income, urban school district in Massachusetts to enhance the palatability and nutrient profile of the school meals. Four schools were randomly assigned to receive the professional chef. Additionally, two schools in that district and four schools in a second school district were randomly assigned to receive a behavioral psychology intervention to influence the selection and consumption of the healthier foods offered. Selection and consumption were assessed at baseline, up to 3 months post-implementation (short-term implementation for chef-enhanced meals), up to 4 months post-implementation (long-term implementation for behavioral psychology) and/or up to 7 months post-implementation (long-term implementation for chef-enhanced meals).
Primary Aim 1: to examine the impact of introducing healthier, chef-enhanced foods with increased palatability on selection and consumption among elementary and middle school students. It is hypothesized that there will be an increase in the selection and consumption of entrees, fruits, and vegetables in schools where healthier, chef-enhanced foods are served.
Aim 2: to examine the impact of physical modifications to the placement and displays of foods in the cafeteria on selection/consumption among elementary and middle school students. It is hypothesized that there will be an increase in selection and consumption of entrees, milk, fruits, and vegetables when modifications are made.
- Conditions
- Meals, Food Habits
- Being tested
- choice architecture, Chef-enhanced meals
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choice architectureBehavioural
Also called Smart Cafe
- Place vegetables at the beginning of the lunch line.
- Place fruits in attractive bowls or trays lined with appealing fabric, and place other fruit options next to the cash registers.
- Promote fruits and vegetables with prominently displayed signage and images.
- Place white milk selection in front of sugar-sweetened milk (e.g. chocolate milk) or at eye-level.
Chef-enhanced mealsOther
meals prepared by a professional chef with enhanced palatability
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Students received standard meals in a standard cafeteria environment |
| Chef | Experimental | Students were exposed to chef-enhanced meals Receives: Other: Chef-enhanced meals |
| choice architecture | Experimental | Students were exposed to modifications to the physical environment in the cafeteria to "nudge" students towards healthier choices Receives: Behavioral: choice architecture |
| Chef and choice architecture | Experimental | Students were exposed to both chef-enhanced meals and modifications to the physical environment in the cafeteria to "nudge" students towards healthier choices Receives: Behavioral: choice architecture; Other: Chef-enhanced meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables)
Selection of entrees, milk, fruits, and vegetables
Measured: baseline, up to 3 months post-implementation, and up to 7 months post-implementation
Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables)
consumption of entrees, milk, fruits, and vegetables
Measured: baseline, up to 3 months post-implementation, and up to 7 months post-implementation
Secondary outcomes (2)
Time to eat (Estimated amount of time spent eating foods)
Estimated amount of time spent eating foods
Measured: up to 24 months
Hunger (Self-reported hunger at the end of the meal)
Self-reported hunger at the end of the meal
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startSep 2011
- Primary completionJun 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MealsStudies 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
- None (open label)
- Enrolment
- 6,873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric B. Rimm, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309840
- Sponsor's protocol ID
- 21198-103
- Acronym
- MEALS
- Status last verified
- Jan 2024
- First submitted
- 18 Nov 2014
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cohen JF, Richardson SA, Cluggish SA, Parker E, Catalano PJ, Rimm EB. Effects of choice architecture and chef-enhanced meals on the selection and consumption of healthier school foods: a randomized clinical trial. JAMA Pediatr. 2015 May;169(5):431-7. doi: 10.1001/jamapediatrics.2014.3805.
PubMed 25798990
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Modifying Eating and Lifestyles at School (MEALS) Study
- ClinicalTrials.gov ID
- NCT02309840
- Acronym / sponsor ID
- MEALS / 21198-103
- Conditions
- Meals, Food Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,873 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Dec 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 purpose of this study is to examine the impact of introducing healthier, chef-enhanced foods and/or environmental modifications (choice architecture) on selection and consumption of school foods among elementary and middle school students.
Detailed description
Project Modifying Eating and Lifestyles at School (MEALS) was a school-based study developed by the nonprofit organization Project Bread (www.ProjectBread.org) and the Harvard School of Public Health. Project Bread hired a professional chef to work with several schools in a low-income, urban school district in Massachusetts to enhance the palatability and nutrient profile of the school meals. Four schools were randomly assigned to receive the professional chef. Additionally, two schools in that district and four schools in a second school district were randomly assigned to receive a behavioral psychology intervention to influence the selection and consumption of the healthier foods offered. Selection and consumption were assessed at baseline, up to 3 months post-implementation (short-term implementation for chef-enhanced meals), up to 4 months post-implementation (long-term implementation for behavioral psychology) and/or up to 7 months post-implementation (long-term implementation for chef-enhanced meals).
Primary Aim 1: to examine the impact of introducing healthier, chef-enhanced foods with increased palatability on selection and consumption among elementary and middle school students. It is hypothesized that there will be an increase in the selection and consumption of entrees, fruits, and vegetables in schools where healthier, chef-enhanced foods are served.
Aim 2: to examine the impact of physical modifications to the placement and displays of foods in the cafeteria on selection/consumption among elementary and middle school students. It is hypothesized that there will be an increase in selection and consumption of entrees, milk, fruits, and vegetables when modifications are made.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Students received standard meals in a standard cafeteria environment |
| Chef | Experimental | Other: Chef-enhanced mealsStudents were exposed to chef-enhanced meals |
| choice architecture | Experimental | Behavioral: choice architectureStudents were exposed to modifications to the physical environment in the cafeteria to "nudge" students towards healthier choices |
| Chef and choice architecture | Experimental | Behavioral: choice architecture, Other: Chef-enhanced mealsStudents were exposed to both chef-enhanced meals and modifications to the physical environment in the cafeteria to "nudge" students towards healthier choices |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students in grades 1-8 attending a participating school and receiving a school meal on a study day
Key exclusion criteria (1 listed)
- Bringing a lunch from home on a study day or not eating lunch in the cafeteria on a study day
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 |
|---|---|---|
| choice architectureAlso: Smart Cafe1. Place vegetables at the beginning of the lunch line. 2. Place fruits in attractive bowls or trays lined with appealing fabric, and place other fruit options next to the cash registers. 3. Promote fruits and vegetables with prominently displayed signage and images. 4. Place white milk selection in front of sugar-sweetened milk (e.g. chocolate milk) or at eye-level. | Behavioural | Chef and choice architecture, choice architecture |
| Chef-enhanced mealsmeals prepared by a professional chef with enhanced palatability | Other | Chef, Chef and choice architecture |
Primary outcome
Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables)
Time frame: baseline, up to 3 months post-implementation, and up to 7 months post-implementation
Selection of entrees, milk, fruits, and vegetables
Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables)
Time frame: baseline, up to 3 months post-implementation, and up to 7 months post-implementation
consumption of entrees, milk, fruits, and vegetables
2 secondary outcomes
Time to eat (Estimated amount of time spent eating foods)
Time frame: up to 24 months
Hunger (Self-reported hunger at the end of the meal)
Time frame: up to 12 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 26 Jan 2024.
- Derived from this study: PubMed 25798990Cohen JF, Richardson SA, Cluggish SA, Parker E, Catalano PJ, Rimm EB. Effects of choice architecture and chef-enhanced meals on the selection and consumption of healthier school foods: a randomized clinical trial. JAMA Pediatr. 2015 May;169(5):431-7. doi: 10.1001/jamapediatrics.2014.3805.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing choice architecture and Chef-enhanced meals in people with Meals and Food Habits, run by Harvard School of Public Health (HSPH).
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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 the selection of meal components (Selection of entrees, milk, fruits, and vegetables) (time frame: baseline, up to 3 months post-implementation, and up to 7 months post-implementation). The study lists 2 primary outcomes in all. 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 NCT02309840, which also lists 1 linked publication.
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 26 Jan 2024.