The Modifying Eating and Lifestyles at School Study (MEALS)

January 24, 2024 updated by: Eric B. Rimm, Harvard School of Public Health (HSPH)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6873

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control
Students received standard meals in a standard cafeteria environment
Experimental: Chef
Students were exposed to chef-enhanced meals
Other: 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
Behavioral: choice architecture
  1. 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.
Other Names:
  • Smart Cafe
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
Other: Chef-enhanced meals
meals prepared by a professional chef with enhanced palatability
Behavioral: choice architecture
  1. 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.
Other Names:
  • Smart Cafe

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard School of Public Health (HSPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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