AzTrials
AzTrials

Fruit and Vegetable Selection in the LunchroomPSANCT01948466

Nutritional PSA's on Fruit and Vegetable Consumption

A study testing Commercials in people with Fruit and Vegetable Selection in the Lunchroom and Consumption Frequency Versus Selection Frequency, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The overall goal of this project is to learn how positive advertising messages impact school food choices. More specifically, this study will determine if positive video messages about fruits and vegetables delivered during the elementary school morning news program can influence children to select more fruits and… Read more about this study

Who is it for?
Ages 7 to 12 yearsHealthy volunteers can take part
What is being tested?
Commercials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
750 participants
Where
1 siteUnited States
Study dates
Jan 2014to Mar 2014
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 7 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 3rd, 4th, or 5th grade students at one of the participating Alachua County Public Schools

Who cannot join

  • not a student at one of the participating schools
  • not in 3rd, 4th, or 5th grade

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Florida

    Gainesville, Florida, 32611

Other trials in United States

About this study

Official title: Using Media to Improve Fruit and Vegetable Consumption in Elementary School Lunch Programs

The overall goal of this project is to learn how positive advertising messages impact school food choices. More specifically, this study will determine if positive video messages about fruits and vegetables delivered during the elementary school morning news program can influence children to select more fruits and vegetables in a school lunch setting. Additionally, it will determine if assessing food selection is representative of food consumption by children in a school lunch room setting.

Read the detailed description

This project will be carried out in three distinct phases: 1) development of commercials, 2) assessing food selection and consumption before, during and after commercial airing, and 3) outcome analysis and dissemination of results. Four elementary schools in Alachua County, Florida will be chosen to participate in this study. Two schools will have high participation in free and reduced fee school lunch programs while two will have lower participation. The schools will be divided such that two participate in the intervention (one with high free/reduced lunch participation and one with low) and two will serve as controls. All schools have a morning broadcast of announcements where 15-30 second fruit and vegetable "commercials" can be shown to all students in K-5th grades. Given the scope (1 year, limited budget) of this pilot project, we will assess purchasing and consumption behaviors of 3rd, 4th, and 5th graders in each school, rather than all children. As students at these schools (and the controls) have the option of what fruits and vegetables to select (if any) as part of the school lunch, the investigators will be able to observe if the commercials have an impact on student choice of healthy products. Students will be assessed collectively per class and thus no individual identifying information will be collected.

Two commercials will be prepared for the schools using messages developed for this age group that feature children as the main characters. This approach captures the potential influence of peers. Potential 3-5th grade "actors" and adult actors will be recruited from local drama/playhouse venues. The two commercials will be shown each week in alternating weeks for a total of four weeks. Example: Week 1, commercial A shown; Week 2, commercial B shown; Week 3, commercial 1 shown; Week 4 commercial B shown. Child actors will likely not attend the test schools, but they and their parents will be informed that the commercials will be shown in two Alachua County Public Schools. Children will include an equal mix of girls and boys and approximately half of the children will be from racial/ethnic minority groups that are represented in the Alachua County school system. These videos will be created using existing video production facilities at the University of Florida.

Six observations will be made at each school to assess the frequency of selection as well as the consumption of fruits and vegetables: once prior to the airing of the commercials, one day during each of the four consecutive weeks when commercials are shown, and once two weeks after the commercial airing has ended. This last assessment will allow the investigators to gather pilot information on whether any lasting effect of the commercials has occurred. At each school, all observations will occur on the same day of the week and children in grades 3-5 will be monitored. The frequency of fruit and vegetable purchase by children will be assessed using a combination of information from student identification numbers at the cash registers and University student monitors to observe the quantity of students selecting the fruit/vegetable promoted in the commercials. To assess food intake, the investigators will photograph each student's tray for future visual plate waste analysis (Silver 2008). Visual plate waste analysis allows trained student and faculty assessors to estimate whether 10, 25, 50, 75, or 90% of a food item remains uneaten on the plate. To evaluate the agreement between selection and consumption, a food item will be considered "consumed" if no more than 25% of the item remains on the plate. Each plate will be evaluated by a minimum of three trained assessors. If the values vary, the item will be discussed as a group until consensus is reached. Moreover, the investigators will work closely with the school food service directors in selecting our days for evaluation and ensuring that equal and adequate amounts of fruits and vegetables are offered on study days.

The primary outcomes are fruit and vegetable selection and consumption. With over 11,500 school students enrolled in the Alachua County School System at 23 elementary schools, we anticipate a total sample size of approximately 1000 3rd, 4th, and 5th grade children. Anticipating a 15% attrition rate over the study period, due primarily to absences, the investigators expect having repeated observations from 850 children, half from intervention schools, half from control schools. Although pilot in nature, this sample size is adequate to detect a mean difference fruit/vegetable selection frequency of 0.5 servings between the study schools with over 99% power using a two-sided 0.05 significance level to detect a standardized effect of 20 standard deviations. Whether food selection can serve as a proxy for food consumption as assessed by visual plate waste analysis will be assessed using regression analysis.

Being tested
Commercials
Keywords
Nutrition, Commercials, Elementary, Lunchroom, Fruits, Vegetables

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CommercialsBehavioural

    Also called PSA's, Video messages, Media messages

    These commercials will display child actors and try to grab the attention of the 3rd - 5th grade viewers. They will be humorous, fun, and call the viewer to action so the students will feel they should consume fruits and vegetables like the children in the commercials.

Study groups in NCT01948466
Study groupRoleWhat they receive
CommercialsExperimentalSchools Administered Commercials
Receives: Behavioral: Commercials
ControlNo interventionSchools not Administered Commercials

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fruit and vegetable selection frequency

    The investigators will measure the frequency of fruit and vegetable selection by the 3rd through 5th graders in the lunchroom by digital photographs to be analyzed at a later time.

    Measured: Six weeks

Secondary outcomes (1)
  1. Plate Waste Analysis

    The investigators will use digital photography assessment to evaluate plate waste analysis as a comparison between fruit and vegetable consumption with selection.

    Measured: Six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
750 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01948466
Sponsor's protocol ID
2013-U-0983
Acronym
PSA
Status last verified
Nov 2016
First submitted
18 Sep 2013
Last updated
17 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Commercials in people with Fruit and Vegetable Selection in the Lunchroom and Consumption Frequency Versus Selection Frequency, run by University of Florida 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 17 Nov 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Fruit and vegetable selection frequency (time frame: Six weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Nov 2016; AzTrials last refreshed its copy on 29 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in