School Lunch Salad Bars and Fruit and Vegetable Consumption

Obesity Clinical Trial

Official title:

Salad Bars and Students' Fruit and Vegetable Consumption: A Group-randomized Trial With Objective Assessments

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03283033
• Other study ID #: R01HL139120
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7491
• Est. completion date: June 30, 2023
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• New salad bar
New salad bar placed in school
• Marketing
Marketing conditions (printed material, displays, verbal announcements, prompts and taste tests)

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in grams of fruit and vegetables consumed	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	Change in grams of fruit and vegetables selected	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)
Secondary	Change in percent of fruit and vegetables wasted	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)