Technology and Design Innovation for School Lunch

May 10, 2019 updated by: University of California, Berkeley

Technology and Design Innovation to Support 21st Century School Nutrition

This study will evaluate an innovative school lunch intervention that is designed to increase school meal participation and improve dietary intake among middle and high 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

Improving dietary intake among low-income youth is critical to reducing obesity, and schools are arguably the most important system in which to intervene. In 2010, Congress passed the Healthy, Hunger-Free Kids Act to better align school meal standards with the Dietary Guidelines, making school meals a nutritious option for students. Increasing participation in the school meal program, therefore, especially among low-income youth, has the potential to improve dietary intake among students and ultimately reduce childhood obesity.

Over three school years, the University of California (Berkeley's School of Public Health and the Division of Agriculture and Natural Resources' Nutrition Policy Institute) will evaluate an innovative, student-centered school-lunch intervention to increase school lunch participation and improve dietary intake among low-income middle and high school students. The project will be conducted in the San Francisco Unified School District (SFUSD), a large and diverse urban district serving over 32,000 students (70% of total) eligible for free or reduced-price meals. The intervention, developed in partnership with the global design firm IDEO, aims to promote healthier habits by leveraging principals of behavior economics. The intervention involves the following three components: 1) a smartphone application (SmartMeal) that allows students to pre-order school lunches, receive nutrition information about school lunch options, and provide feedback about meals to food service staff, 2) distributed points of sale for school meals, achieved through the addition of mobile food carts and vending machines, and 3) a staff wellness curriculum that encourages staff to promote school meals and model healthful eating behaviors to students.

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.
27406

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States
        • Academy High School and Ruth Asawa School of the Arts
      • San Francisco, California, United States
        • AP Giannini Middle School
      • San Francisco, California, United States
        • Aptos Middle School
      • San Francisco, California, United States
        • Balboa High School
      • San Francisco, California, United States
        • Burton High School
      • San Francisco, California, United States
        • Everett Middle School
      • San Francisco, California, United States
        • Francisco Middle School
      • San Francisco, California, United States
        • Galileo High School
      • San Francisco, California, United States
        • Herbert Hoover Middle School
      • San Francisco, California, United States
        • James Denman Middle School
      • San Francisco, California, United States
        • James Lick Middle School
      • San Francisco, California, United States
        • John O'Connell High School
      • San Francisco, California, United States
        • June Jordan High School
      • San Francisco, California, United States
        • Lincoln High School
      • San Francisco, California, United States
        • Lowell High School
      • San Francisco, California, United States
        • Marina Middle School
      • San Francisco, California, United States
        • Marshall High School
      • San Francisco, California, United States
        • Martin Luther King Middle School
      • San Francisco, California, United States
        • Mission High School
      • San Francisco, California, United States
        • Presidio Middle School
      • San Francisco, California, United States
        • Roosevelt Middle School
      • San Francisco, California, United States
        • Visitacion Valley Middle School
      • San Francisco, California, United States
        • Wallenberg High School
      • San Francisco, California, United States
        • Washington High School

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
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All 7th-10th grade students at participating schools are eligible to participate in the student survey
  • All 6th-12th grade students who eat the school lunch are eligible to participate in plate waste data collection
  • All 7th-10th grade teachers are eligible to participate in the teacher survey

Exclusion Criteria:

  • There are no exclusion criteria

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel 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.
Experimental: School lunch intervention
Intervention schools (6 middle and 6 high) will receive the complete school lunch intervention for two school years.
Behavioral: SmartMeal application
The SmartMeal application is a smartphone application that will allow students to pre-order school meals, receive nutrition information about school meals, and provide feedback about school meals to Student Nutrition Services.
Behavioral: Distributed points of sale
To increase points of sale for school meals (outside the cafeteria), school meals will be sold at hot and cold mobile food carts and vending machines throughout the school.
Behavioral: Staff wellness curriculum
A wellness curriculum will be implemented that encourages teachers and staff members to eat school meals and promote them to students.
No Intervention: School lunch control
Control schools (6 middle and 6 high) will not receive the school lunch intervention for two school years. Lunch delivery will proceed as normal.

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 school lunch participation
Time Frame: 2 years
Daily school lunch participation records broken down by grade, gender, and free or reduced-price meal eligibility at each school.
2 years

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
Change in plate waste during lunch among students who eat school lunch
Time Frame: 2 school years
Individual-level waste of food components achieved through visual estimation and aggregate waste of food components achieved through weighing.
2 school years
Change in fruit consumption at lunch
Time Frame: 2 school years
Student survey that asks about fruits consumed at lunch yesterday
2 school years
Change in vegetable consumption at lunch
Time Frame: 2 school years
Student survey that asks about vegetables consumed at lunch yesterday
2 school years
Change in weekly fruit consumption
Time Frame: 2 school years
Student survey that asks about fruits consumed during a typical week
2 school years
Change in weekly vegetable consumption
Time Frame: 2 school years
Student survey that asks about vegetables consumed during a typical week
2 school years
Change in variety of fruits consumed by students at lunch
Time Frame: 2 school years
Student survey that asks about fruits consumed at lunch yesterday
2 school years
Change in variety of vegetables consumed by students at lunch
Time Frame: 2 school years
Student survey that asks about vegetables consumed at lunch yesterday
2 school years
Change in variety of fruits consumed by students each week
Time Frame: 2 school years
Student survey that asks about fruits consumed during a typical week
2 school years
Change in variety of vegetables consumed by students each week
Time Frame: 2 school years
Student survey that asks about vegetables consumed during a typical week
2 school years
Change in body mass index (index)
Time Frame: 2 school years
BMI data collected each year on 7th and 9th grade students via the California Physical Fitness Test
2 school years

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.
University of California, Berkeley

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristine A Madsen, MD MPH, University of California, Berkeley
  • Principal Investigator: Lorrene Ritchie, PhD RD, University of California Division of Agriculture and Natural Resources

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.
February 1, 2016

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, 2018

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, 2018

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).
June 8, 2015

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.
June 8, 2015

First Posted (Estimate)

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.
June 10, 2015

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.
May 14, 2019

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.
May 10, 2019

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.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2014-12-7010

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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