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NCT Number: NCT07727746

Fruit and Vegetable Study - Pilot

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.

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Key information

Conditions

Fruit and Vegetable Consumption in Children Caregiver Nutrition Fruit and Vegetable Consumption Fruit and Vegetable Selection in the Lunchroom

Age range

7 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Biomedical Collaberative

Phoenix, Arizona, 85004, United States

Location contact

Kristi Kristi Mollner, MS

CONTACT

[email protected]

480-965-5477

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 Spanish.

Treatment and study plan

FFVP+

Behavioral

FFVP+ is a public private partnership intervention that links elementary schools participating in the USDA Fresh Fruit and Vegetable Program with nearby Bashas' Food City stores. Schools continue usual FFVP activities, including offering fresh fruit and vegetable snacks twice weekly, and add school based promotion and messaging to encourage students to ask caregivers about the fruits and vegetables offered at school. The paired Food City store implements coordinated fruit and vegetable promotion for the same or similar items, such as bilingual signage, shelf tags, taste testing, QR codes, in-store announcements, and other feasible produce promotion strategies. The goal is to extend FFVP exposure beyond school and into the household and neighborhood retail food environment.

FFVP-only

Behavioral

FFVP-only schools will continue usual implementation of the USDA Fresh Fruit and Vegetable Program. Through FFVP, participating elementary schools offer students fresh fruit and vegetable snacks at least twice per week during the school day to increase exposure to and acceptance of fruits and vegetables. Schools may continue their usual FFVP-related procedures and any standard nutrition education or food service activities already occurring in the school setting. FFVP-only schools will not receive the added FFVP+ public private partnership components, including coordinated promotion with Food City stores or study-supported store based promotion of FFVP fruits and vegetables.

Primary outcomes

  1. Change From Baseline in Child Skin Carotenoid Score as Assessed by Veggie Meter at End of Year

    Time frame: Baseline to end of school year, approximately 8 to 9 months

    Child fruit and vegetable consumption will be assessed using skin carotenoid levels measured with the Veggie Meter, a non-invasive reflection spectroscopy device. At each assessment, three measurements will be taken from the same finger and averaged. Values can range from 0 (low consumption) to 800 (high consumption). The outcome will be reported as the mean change in child skin carotenoid score from baseline to end of year.

  2. Mean Change From Baseline in Caregiver Skin Carotenoid Score as Assessed by Veggie Meter at End of Year

    Time frame: Baseline to end of school year, approximately 8 to 9 months

    Caregiver fruit and vegetable consumption will be assessed using skin carotenoid levels measured with the Veggie Meter, a non-invasive reflection spectroscopy device. At each assessment, three measurements will be taken from the same finger and averaged. Values can range from 0 (low consumption) to 800 (high consumption). The outcome will be reported as the mean change in caregiver skin carotenoid score from baseline to end of year.

Secondary outcomes

  1. Mean Change From Baseline in Child Fruit and Vegetable Consumption During School Lunch as Assessed by Plate Waste at End of Year

    Time frame: Baseline to end of school year, approximately 8 to 9 months

    Child fruit and vegetable consumption during school lunch will be assessed using plate waste methods. Fruit and vegetable items selected by participating students will be weighed before and after lunch to estimate grams of fruits and vegetables consumed. The outcome will be reported as the mean change in grams of fruits and vegetables consumed during school lunch from baseline to end of year.

  2. Mean Change From Baseline in Child Self-Reported Fruit and Vegetable Intake as Assessed by Dietary Screener Questions at End of Year

    Time frame: Baseline to end of school year, approximately 8 to 9 months

    Child self-reported fruit and vegetable intake will be assessed using fruit and vegetable screener questions adapted from the National Cancer Institute Dietary Screener Questionnaire. Responses will be used to estimate usual fruit and vegetable intake. The outcome will be reported as the mean change in estimated child fruit and vegetable intake from baseline to end of year.

  3. Mean Change From Baseline in Caregiver Self-Reported Fruit and Vegetable Intake as Assessed by Dietary Screener Questions at End of Year

    Time frame: Baseline to end of year, approximately 8 to 9 months

    Caregiver self-reported fruit and vegetable intake will be assessed using fruit and vegetable screener questions from the National Cancer Institute Dietary Screener Questionnaire. Responses will be used to estimate usual fruit and vegetable intake. The outcome will be reported as the mean change in estimated caregiver fruit and vegetable intake from baseline to end of year.

Other outcomes

  1. Proportion of Target Student-Caregiver Dyads Enrolled During the Phase 1 Recruitment Period

    Time frame: From start of recruitment to the end of school year, approximately 9 to 10 months

    Feasibility of recruitment will be assessed by the number and proportion of eligible student-caregiver dyads enrolled compared with the Phase 1 target enrollment. Recruitment yield will also be summarized by recruitment approach, including school based, store based, and social media recruitment strategies.

  2. Proportion of Enrolled Student-Caregiver Dyads Completing Planned Study Assessments Across the Phase 1 Pilot

    Time frame: Baseline, mid-year, and end of year during one academic year

    Feasibility of data collection and retention will be assessed by the proportion of enrolled student-caregiver dyads who complete planned study assessments across the Phase 1 pilot. Planned assessments include Veggie Meter measures, student and caregiver surveys, height and weight measures, and student school lunch plate waste assessments.

  3. Proportion of Planned FFVP+ School-Store Partnership Activities Implemented During the Phase 1 Pilot

    Time frame: From baseline to the end of school year, approximately 8 to 9 months

    Feasibility of implementing the FFVP+ intervention will be assessed by the proportion of planned school-store partnership activities completed during the Phase 1 pilot. Activities include coordinating fruit and vegetable promotion between participating schools and paired Food City stores, implementing planned store based promotion strategies, documenting communication between schools and stores, and completing planned fidelity checks.

Study contacts

Contact information is provided by the study sponsor or research team.

Marc A Adams, PhD, MPH

CONTACT

[email protected]

480-884-2544

Punan Ohri-Vachaspati, PhD

CONTACT

[email protected]

480-884-2546

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Amplifying the Impact of the Fresh Fruit and Vegetable Program (FFVP) Beyond Schools: A Multisectoral Approach Pilot

Acronym: FFVP+ Pilot

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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