- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283033
School Lunch Salad Bars and Fruit and Vegetable Consumption
October 26, 2021 updated by: Marc Adams, PhD, MPH, Arizona State University
Salad Bars and Students' Fruit and Vegetable Consumption: A Group-randomized Trial With Objective Assessments
The investigators propose an efficacy study (i.e., do salad bars work under controlled conditions in naturalistic settings) to test whether introducing salad bars in elementary, middle, and high schools that have never had salad bars affects students' FV consumption and waste during lunch.
A cluster randomized controlled trial will test new salad bars against controls for 6 wks, with/without an additional 4-wk marketing phase .
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
6408
Phase
- 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 Contact
- Name: Marc A Adams, PhD
- Phone Number: 6028272470
- Email: marc.adams@asu.edu
Study Contact Backup
- Name: Meg Bruening, PhD
- Email: meg.bruening@asu.edu
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Recruiting
- Arizona State University
-
Contact:
- Marc A Adams
-
-
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
Ages Eligible for Study
6 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Students enrolled in any grade between grades one and twelve
- Student ID number matches that on a list of randomly selected student ID numbers from the population of student enrolled in school
- Students who elect to receive a hot entree at lunch
- Students who assent to participate
Exclusion Criteria:
- Students in detention
- Students in special education
- Students in Kindergarten
- Students not in school for any reason (e.g. illness, vacation)
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental 3
Introduction of a new salad bar and marketing conditions during second semester of school year
|
New salad bar placed in school
Marketing conditions (printed material, displays, verbal announcements, prompts and taste tests)
|
EXPERIMENTAL: Experimental 2
Introduction of marketing conditions during second semester of school year
|
Marketing conditions (printed material, displays, verbal announcements, prompts and taste tests)
|
EXPERIMENTAL: Experimental 1
Introduction of a new salad bar during second semester of school year
|
New salad bar placed in school
|
NO_INTERVENTION: Control
No introduction of a new salad bar and no introduction of marketing conditions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in grams of fruit and vegetables consumed
Time Frame: Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)
|
The amount (grams) of fresh and canned fruits and vegetables consumed at lunch
|
Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in grams of fruit and vegetables selected
Time Frame: Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)
|
The amount (grams) of fresh and canned fruits and vegetables selected at lunch
|
Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)
|
Change in percent of fruit and vegetables wasted
Time Frame: Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)
|
The percent of fresh and canned fruits and vegetables wasted at lunch
|
Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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 (ACTUAL)
October 1, 2017
Primary Completion (ANTICIPATED)
June 30, 2022
Study Completion (ANTICIPATED)
June 30, 2022
Study Registration Dates
First Submitted
September 12, 2017
First Submitted That Met QC Criteria
September 12, 2017
First Posted (ACTUAL)
September 14, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 28, 2021
Last Update Submitted That Met QC Criteria
October 26, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- R01HL139120 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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