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TerminatedNCT03283033Updated Nov 24, 2023

School Lunch Salad Bars and Fruit and Vegetable Consumption

An interventional study of New salad bar and Marketing in Children, Only, Behavior, Eating and School, sponsored by Arizona State University. Terminated at 1 site in United States. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Arizona State University · Not applicable, Interventional, and Prevention

Why this study was terminated
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.
Phase
Not applicable
Study type
Interventional
Enrollment
7,491
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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. A cluster randomized controlled trial will test new salad bars against controls for 6 wks, with/without an additional 4-wk marketing phase .

02

Conditions studied

  • Children, Only
  • Behavior, Eating
  • School
  • Obesity
  • Food Selection
  • Food Habits
  • Diet Modification
  • Adolescent Behavior

Keywords

  • Children
  • Plate Waste
  • Fruit and vegetable intake
  • School lunch
  • social marketing
03

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Students in detention
  • Students in special education
  • Students in Kindergarten
  • Students not in school for any reason (e.g. illness, vacation)
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
7,491 participants (actual)

Study arms

  • Experimental
    Experimental 3

    Introduction of a new salad bar and marketing conditions during second semester of school year

    Behavioral: New salad bar · Behavioral: Marketing

  • Experimental
    Experimental 2

    Introduction of marketing conditions during second semester of school year

    Behavioral: Marketing

  • Experimental
    Experimental 1

    Introduction of a new salad bar during second semester of school year

    Behavioral: New salad bar

  • No intervention
    Control

    No introduction of a new salad bar and no introduction of marketing conditions

Interventions

  • BehavioralNew salad bar

    New salad bar placed in school

  • BehavioralMarketing

    Marketing conditions (printed material, displays, verbal announcements, prompts and taste tests)

05

What researchers measure

Primary outcomes

  1. Change in grams of fruit and vegetables consumed

    The amount (grams) of fresh and canned fruits and vegetables consumed at lunch

    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)

Secondary outcomes

  1. Change in grams of fruit and vegetables selected

    The amount (grams) of fresh and canned fruits and vegetables selected at lunch

    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)

  2. Change in percent of fruit and vegetables wasted

    The percent of fresh and canned fruits and vegetables wasted at lunch

    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)

06

Study locations

1 site
  • Arizona State University
    Phoenix, Arizona 85004, United States
07

References and documents

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 30572161 ↗
  • Bruening 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 29214812 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03283033
Lead sponsor
Arizona State University
Collaborators
National Institutes of Health (NIH)
Responsible party
Marc Adams, PhD, MPH (Assistant Professor, Arizona State University) — Principal investigator
First posted
Sep 14, 2017
Start date
Oct 1, 2017
Primary completion
Sep 10, 2021
Completion
Jun 30, 2023
Last update
Nov 24, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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