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CompletedNCT01948466PSAUpdated Nov 17, 2016

Nutritional PSA's on Fruit and Vegetable Consumption

An interventional study of Commercials in Fruit and Vegetable Selection in the Lunchroom and Consumption Frequency Versus Selection Frequency, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-17.

Sponsored by University of Florida · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Fruit and Vegetable Selection in the Lunchroom
  • Consumption Frequency Versus Selection Frequency

Keywords

  • Nutrition
  • Commercials
  • Elementary
  • Lunchroom
  • Fruits
  • Vegetables
03

In context

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • not a student at one of the participating schools
  • not in 3rd, 4th, or 5th grade
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
750 participants (actual)

Study arms

  • Experimental
    Commercials

    Schools Administered Commercials

    Behavioral: Commercials

  • No intervention
    Control

    Schools not Administered Commercials

Interventions

  • BehavioralCommercials

    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.

    Also known as: PSA's, Video messages, Media messages

06

What researchers measure

Primary outcomes

  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.

    Time frame: Six weeks

Secondary outcomes

  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.

    Time frame: Six weeks

07

Study locations

1 site
  • University of Florida
    Gainesville, Florida 32611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01948466
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Sep 23, 2013
Start date
Jan 2014
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Nov 17, 2016

Study contacts

Anne Mathews, PhD, RD, LDN
principal investigator · University of Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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