Fruit and Vegetable Consumption in ChildrenFFVP+ PilotNCT07727746
Fruit and Vegetable Study - Pilot
A study testing FFVP+ and FFVP-only in people with Fruit and Vegetable Consumption in Children and Fruit and Vegetable Consumption, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fruit and Vegetable Consumption in Children, Fruit and Vegetable Consumption, Fruit and Vegetable Selection in the Lunchroom
- What is being tested?
- FFVP+ and FFVP-only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Arizona Biomedical Collaberative
Phoenix, Arizona, 85004
Kristi Kristi Mollner, MS, 480-965-5477, kristi.mollner@asu.edu
About this study
Official title: Amplifying the Impact of the Fresh Fruit and Vegetable Program (FFVP) Beyond Schools: A Multisectoral Approach 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.
Read more
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
- Being tested
- FFVP+, FFVP-only
- Keywords
- Skin carotenoids, Retail food environment, Veggie Meter, Plate waste, School based nutrition intervention, Fruit and vegetable consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFVP+Behavioural
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-onlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FFVP+ | Experimental | Receives the standard Fresh Fruit and Vegetable Program + Public Private Partnership Receives: Behavioral: FFVP+ |
| FFVP-only | Active comparator | Receives the standard Fresh Fruit and Vegetable Program Receives: Behavioral: FFVP-only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline to end of year, approximately 8 to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fruit and Vegetable Consumption in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm cluster-randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marc Adams, PhD, MPH, Arizona State University
- Investigators
- Marc A Adams, PhD, MPH, Principal investigator, Arizona State UniversityPunam Ohri-Vachaspati, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727746
- Sponsor's protocol ID
- STUDY00023861: FFVP+
- Other IDs
- UG3HL179928
- Acronym
- FFVP+ Pilot
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The MPIs will maintain all original data and, following the publication of primary and secondary aims, will accept data-sharing requests from qualified investigators. All requests will be reviewed and approved by the MPIs prior to data release. Shared datasets will be de-identified and free of variables that could lead to the disclosure of identities. All data-sharing procedures will comply with institutional and IRB policies at Arizona State University, NIH policy, and other applicable laws and regulations. Monitoring and compliance with this Data Management and Sharing Plan will be the responsibility of Drs. Ohri-Vachaspati and Adams. The plan will be implemented and managed by professional staff under the MPIs' direction.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplifying the Impact of the Fresh Fruit and Vegetable Program (FFVP) Beyond Schools: A Multisectoral Approach Pilot
- ClinicalTrials.gov ID
- NCT07727746
- Acronym / sponsor ID
- FFVP+ Pilot / STUDY00023861: FFVP+
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2-arm cluster-randomized trial
| Arm | Type | Receives |
|---|---|---|
| FFVP+ | Experimental | Behavioral: FFVP+Receives the standard Fresh Fruit and Vegetable Program + Public Private Partnership |
| FFVP-only | Active comparator | Behavioral: FFVP-onlyReceives the standard Fresh Fruit and Vegetable Program |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFVP+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. | Behavioural | FFVP+ |
| FFVP-onlyFFVP-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. | Behavioural | FFVP-only |
Primary outcome
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.
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.
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The MPIs will maintain all original data and, following the publication of primary and secondary aims, will accept data-sharing requests from qualified investigators. All requests will be reviewed and approved by the MPIs prior to data release. Shared datasets will be de-identified and free of variables that could lead to the disclosure of identities. All data-sharing procedures will comply with institutional and IRB policies at Arizona State University, NIH policy, and other applicable laws and regulations. Monitoring and compliance with this Data Management and Sharing Plan will be the responsibility of Drs. Ohri-Vachaspati and Adams. The plan will be implemented and managed by professional staff under the MPIs' direction.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc A Adams, PhD, MPH principal investigator
Arizona State University
Punam Ohri-Vachaspati, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFVP+ and FFVP-only in people with Fruit and Vegetable Consumption in Children and Fruit and Vegetable Consumption, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc A Adams, PhD, MPH (480-884-2544, marc.adams@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.