Children, OnlyNCT03283033
School Lunch Salad Bars and Fruit and Vegetable Consumption
A study testing New salad bar and Marketing in people with Children, Only and Behavior, Eating, run by Arizona State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Only, Behavior, Eating, School
- What is being tested?
- New salad bar and Marketing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,491 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 30 Jun 2023
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Students in detention
- Students in special education
- Students in Kindergarten
- Students not in school for any reason (e.g. illness, vacation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
- Conditions
- Children, Only, Behavior, Eating, School, Obesity, Food Selection, Food Habits
- Being tested
- New salad bar, Marketing
- Keywords
- Children, Plate Waste, Fruit and vegetable intake, School lunch, social marketing
- Medical subject headings
- Feeding Behavior, Obesity, Food Preferences, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New salad barBehavioural
New salad bar placed in school
MarketingBehavioural
Marketing conditions (printed material, displays, verbal announcements, prompts and taste tests)
| Study group | Role | What they receive |
|---|---|---|
| Experimental 3 | Experimental | Introduction of a new salad bar and marketing conditions during second semester of school year Receives: Behavioral: New salad bar; Behavioral: Marketing |
| Experimental 2 | Experimental | Introduction of marketing conditions during second semester of school year Receives: Behavioral: Marketing |
| Experimental 1 | Experimental | Introduction of a new salad bar during second semester of school year Receives: Behavioral: New salad bar |
| Control | No intervention | No introduction of a new salad bar and no introduction of marketing conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in grams of fruit and vegetables consumed
The amount (grams) of fresh and canned fruits and vegetables consumed at lunch
Measured: Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)
Secondary outcomes (2)
Change in grams of fruit and vegetables selected
The amount (grams) of fresh and canned fruits and vegetables selected at lunch
Measured: 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
The percent of fresh and canned fruits and vegetables wasted at lunch
Measured: Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Oct 2017
- Primary completion10 Sep 2021
- Study completion30 Jun 2023
Why it stopped: COVID-19 closed schools in March 2020. Data collection for all elementary schools was completed pre-pandemic. For middle and high schools, the marketing phase was halted. Results will solely reflect the salad bar intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Children, OnlyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7,491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Marc Adams, PhD, MPH, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283033
- Sponsor's protocol ID
- R01HL139120
- Status last verified
- Nov 2023
- First submitted
- 12 Sep 2017
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams MA, Ohri-Vachaspati P, Richards TJ, Todd M, Bruening M. Design and rationale for evaluating salad bars and students' fruit and vegetable consumption: A cluster randomized factorial trial with objective assessments. Contemp Clin Trials. 2019 Feb;77:37-45. doi: 10.1016/j.cct.2018.12.007. Epub 2018 Dec 18.
PubMed 30572161Bruening M, Adams MA, Ohri-Vachaspati P, Hurley J. Prevalence and Implementation Practices of School Salad Bars Across Grade Levels. Am J Health Promot. 2018 Jul;32(6):1375-1382. doi: 10.1177/0890117116689159. Epub 2017 Feb 19.
PubMed 29214812Adams MA, Todd M, McEntee ML, Yu TY, Ohri-Vachaspati P, Richards TJ, Bruening M. A cluster randomized factorial trial of school-lunch salad bars and marketing on elementary students' objectively measured fruit and vegetable consumption. Int J Behav Nutr Phys Act. 2025 May 26;22(1):58. doi: 10.1186/s12966-025-01758-z.
PubMed 40420203
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salad Bars and Students' Fruit and Vegetable Consumption: A Group-randomized Trial With Objective Assessments
- ClinicalTrials.gov ID
- NCT03283033
- Acronym / sponsor ID
- R01HL139120
- Conditions
- Children, Only, Behavior, Eating, School, Obesity, Food Selection, Food Habits
- Keywords
- Children, Plate Waste, Fruit and vegetable intake, School lunch, social marketing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 closed schools in March 2020. Data collection for all elementary schools was completed pre-pandemic. For middle and high schools, the marketing phase was halted. Results will solely reflect the salad bar intervention.
- Enrolment
- 7,491 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Sep 2017 (actual)
- 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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental 3 | Experimental | Behavioral: New salad bar, Behavioral: MarketingIntroduction of a new salad bar and marketing conditions during second semester of school year |
| Experimental 2 | Experimental | Behavioral: MarketingIntroduction of marketing conditions during second semester of school year |
| Experimental 1 | Experimental | Behavioral: New salad barIntroduction of a new salad bar during second semester of school year |
| Control | No intervention | –No introduction of a new salad bar and no introduction of marketing conditions |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Students in detention
- Students in special education
- Students in Kindergarten
- Students not in school for any reason (e.g. illness, vacation)
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 |
|---|---|---|
| New salad barNew salad bar placed in school | Behavioural | Experimental 1, Experimental 3 |
| MarketingMarketing conditions (printed material, displays, verbal announcements, prompts and taste tests) | Behavioural | Experimental 2, Experimental 3 |
Primary outcome
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
2 secondary outcomes
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)
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)
Results and safety
The study was stopped early (reason given: COVID-19 closed schools in March 2020. Data collection for all elementary schools was completed pre-pandemic. For middle and high schools, the marketing phase was halted. Results will solely reflect the salad bar intervention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 30572161Adams MA, Ohri-Vachaspati P, Richards TJ, Todd M, Bruening M. Design and rationale for evaluating salad bars and students' fruit and vegetable consumption: A cluster randomized factorial trial with objective assessments. Contemp Clin Trials. 2019 Feb;77:37-45. doi: 10.1016/j.cct.2018.12.007. Epub 2018 Dec 18.
- Results publication: PubMed 29214812Bruening M, Adams MA, Ohri-Vachaspati P, Hurley J. Prevalence and Implementation Practices of School Salad Bars Across Grade Levels. Am J Health Promot. 2018 Jul;32(6):1375-1382. doi: 10.1177/0890117116689159. Epub 2017 Feb 19.
- Derived from this study: PubMed 40420203Adams MA, Todd M, McEntee ML, Yu TY, Ohri-Vachaspati P, Richards TJ, Bruening M. A cluster randomized factorial trial of school-lunch salad bars and marketing on elementary students' objectively measured fruit and vegetable consumption. Int J Behav Nutr Phys Act. 2025 May 26;22(1):58. doi: 10.1186/s12966-025-01758-z.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New salad bar and Marketing in people with Children, Only and Behavior, Eating, run by Arizona State University at 1 site in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: COVID-19 closed schools in March 2020. Data collection for all elementary schools was completed pre-pandemic. For middle and high schools, the marketing phase was halted. Results will solely reflect the salad bar intervention.). Results are not available in the source record.
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 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)). 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 NCT03283033, which also lists 3 linked publications.
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 24 Nov 2023.