- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02309840
The Modifying Eating and Lifestyles at School Study (MEALS)
The Modifying Eating and Lifestyles at School (MEALS) Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Students in grades 1-8 attending a participating school and receiving a school meal on a study day
Exclusion Criteria:
- Bringing a lunch from home on a study day or not eating lunch in the cafeteria on a study day
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
Students received standard meals in a standard cafeteria environment
|
|
|
Experimental: Chef
Students were exposed to chef-enhanced meals
|
meals prepared by a professional chef with enhanced palatability
|
|
Experimental: choice architecture
Students were exposed to modifications to the physical environment in the cafeteria to "nudge" students towards healthier choices
|
Other Names:
|
|
Experimental: Chef and choice architecture
Students were exposed to both chef-enhanced meals and modifications to the physical environment in the cafeteria to "nudge" students towards healthier choices
|
meals prepared by a professional chef with enhanced palatability
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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)
Time Frame: baseline, up to 3 months post-implementation, and up to 7 months post-implementation
|
consumption of entrees, milk, fruits, and vegetables
|
baseline, up to 3 months post-implementation, and up to 7 months post-implementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to eat (Estimated amount of time spent eating foods)
Time Frame: up to 24 months
|
Estimated amount of time spent eating foods
|
up to 24 months
|
|
Hunger (Self-reported hunger at the end of the meal)
Time Frame: up to 12 months
|
Self-reported hunger at the end of the meal
|
up to 12 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 21198-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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