Fruit and Vegetable Study - Pilot

NCT07727746 | Not Yet Recruiting

• 2 other identifiers: STUDY00023861: FFVP+UG3HL179928
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Skin carotenoids; Retail food environment; Veggie Meter; Plate waste; School based nutrition intervention; Fruit and vegetable consumption

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline to end of school year, approximately 8 to 9 months

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

  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.

  Baseline to end of school year, approximately 8 to 9 months

Secondary Outcomes (3)

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

  Baseline to end of school year, approximately 8 to 9 months

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

  Baseline to end of school year, approximately 8 to 9 months

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

  Baseline to end of year, approximately 8 to 9 months

Other Outcomes (3)

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

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

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

  Baseline, mid-year, and end of year during one academic year

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

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

Study Arms (2)

FFVP+

EXPERIMENTAL

Receives the standard Fresh Fruit and Vegetable Program + Public Private Partnership

Behavioral: FFVP+

FFVP-only

ACTIVE COMPARATOR

Receives the standard Fresh Fruit and Vegetable Program

Behavioral: FFVP-only

Interventions

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+

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.

FFVP-only

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Arizona Biomedical Collaberative

Phoenix, Arizona, 85004, United States

Location

Related Links

• Related Info

Study Officials

• Marc A Adams, PhD, MPH

  Arizona State University

  PRINCIPAL INVESTIGATOR

• Punam Ohri-Vachaspati, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc A Adams, PhD, MPH

CONTACT

480-884-2544; marc.adams@asu.edu

Punan Ohri-Vachaspati, PhD

CONTACT

480-884-2546; pohrivac@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2-arm cluster-randomized trial

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)