Fruit and Vegetable Study - Pilot (NCT07727746) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fruit and Vegetable Study - Pilot
United States880 participantsStarted 2026-07
Plain-language summary
Arizona State University is studying how local schools and grocery stores can work together to promote fruits and vegetables and support healthy eating among children and families.
The goal of this pilot cluster clinical trial is to determine whether FFVP+, a public private partnership between elementary schools and regional Bashas' Food City stores, can used to support fruit and vegetable promotion among children and their caregivers. The study will include elementary school students and caregivers from elementary schools participating in the USDA Fresh Fruit and Vegetable Program.
The main questions it aims to answer are:
Can schools and Food City stores coordinate promotion of fruits and vegetables through the FFVP+ partnership?
Can we recruit and retain student and caregiver dyads and collect the planned measures across the school year?
Do children and caregivers in the FFVP+ schools consume more fruits and vegetables than schools not receiving this enhanced intervention.
Researchers will compare schools receiving FFVP+ to schools receiving the usual Fresh Fruit and Vegetable Program only. This will help us understand whether the partnership is feasible, whether the recruitment and data collection procedures work, and whether the approach is ready to be tested in a larger trial.
Participants will:
Complete study visits at three time points during the school year
Complete surveys about fruit and vegetable intake, preferences, household food availability, and shopping practices
Have fruit and vegetable intake measured using a non-invasive Veggie Meter device
Have height and weight measured
Students will also have fruit and vegetable intake measured during school lunch using plate waste methods.
Who can participate
Age range
7 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Stores: Must be a Food City store located within the Maricopa or Pinal County regions.
* FFVP Schools: Must 1) be located within 1-mile radius of a Food City store; 2) have 2 years of continuous prior experience in the USDA-funded FFVP program; 3) intend to offer FFVP at least 2 days/week over the school year; and 4) are not participating in other FV related research.
* Non-FFVP School: Must 1) be located within 1-mile radius of a Food City store; 2) eligible for USDA-funding, but not awarded funding for the FFVP program; and 3) are not participating in other FV related research.
* Children/students: Include 1) boys and girls enrolled in 3rd - 6th grade at participating schools, 2) with parent/caregiver consent, 3) regularly participating in the school-lunch program.
* Parent/Caregiver: Must be 1) an adult aged 18 years or older and 2) a primary caregiver (parent or guardian with at least 50% custody) of the selected child attending a participating school.
Exclusion Criteria:
* Schools outside Maricopa and Pinal regions will be excluded. Grocery stores other than Bashas' Food City will be excluded due to the participation of this retail partner in the grant.
* Students will be excluded if they are not enrolled in grades 3 through 6, do not have parent/caregiver consent, do not provide assent, or do not participate in the school lunch program.
* Parents/caregivers will be excluded if they do not provide consent or cannot read or write in English or Spa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Child Skin Carotenoid Score as Assessed by Veggie Meter at End of Year
Timeframe: Baseline to end of school year, approximately 8 to 9 months
2
Mean Change From Baseline in Caregiver Skin Carotenoid Score as Assessed by Veggie Meter at End of Year
Timeframe: Baseline to end of school year, approximately 8 to 9 months