Fruit and Vegetable Study - Pilot

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое FFVP-only
  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 recei

Первичные конечные точки

• Change From Baseline in Child Skin Carotenoid Score as Assessed by Veggie Meter at End of Year [Срок оценки: 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 [Срок оценки: Baseline to end of school year, approximately 8 to 9 months]

Вторичные конечные точки (3)

• Mean Change From Baseline in Child Fruit and Vegetable Consumption During School Lunch as Assessed by Plate Waste at End of Year [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline to end of year, approximately 8 to 9 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Arizona Biomedical Collaberative — Phoenix

Идентификаторы

NCT: NCT07727746 · STUDY00023861: FFVP+ · UG3HL179928

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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