[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07727746":3,"trial-entities:NCT07727746":120,"trial-summary:NCT07727746":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":46,"secondary_outcomes":54,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":68,"eligibility_criteria":69,"std_ages":81,"locations":85,"central_contacts":101,"overall_officials":110,"references":115,"see_also_links":116},"NCT07727746","STUDY00023861: FFVP+","Fruit and Vegetable Study - Pilot","Amplifying the Impact of the Fresh Fruit and Vegetable Program (FFVP) Beyond Schools: A Multisectoral Approach Pilot","NOT_YET_RECRUITING","2027-07","2026-07","2026-07-27","Arizona State University","OTHER",false,"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.\n\nThe 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.\n\nThe main questions it aims to answer are:\n\nCan schools and Food City stores coordinate promotion of fruits and vegetables through the FFVP+ partnership?\n\nCan we recruit and retain student and caregiver dyads and collect the planned measures across the school year?\n\nDo children and caregivers in the FFVP+ schools consume more fruits and vegetables than schools not receiving this enhanced intervention.\n\nResearchers 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.\n\nParticipants will:\n\nComplete study visits at three time points during the school year\n\nComplete surveys about fruit and vegetable intake, preferences, household food availability, and shopping practices\n\nHave fruit and vegetable intake measured using a non-invasive Veggie Meter device\n\nHave height and weight measured\n\nStudents will also have fruit and vegetable intake measured during school lunch using plate waste methods.",null,[18,19,20,21],"Fruit and Vegetable Consumption in Children","Fruit and Vegetable Consumption","Fruit and Vegetable Selection in the Lunchroom","Caregiver Nutrition",[23,24,25,26,27,28],"Skin carotenoids","Retail food environment","Veggie Meter","Plate waste","School based nutrition intervention","Fruit and vegetable consumption","INTERVENTIONAL","PREVENTION",[32],"NA",{"count":34,"type":35},880,"ESTIMATED",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","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.",[39],{"type":38,"name":43,"description":44,"armGroupLabels":45},"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 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.",[43],[47,51],{"measure":48,"description":49,"timeFrame":50},"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",{"measure":52,"description":53,"timeFrame":50},"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.",[55,58,61],{"measure":56,"description":57,"timeFrame":50},"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.",{"measure":59,"description":60,"timeFrame":50},"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.",{"measure":62,"description":63,"timeFrame":64},"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.","Baseline to end of year, approximately 8 to 9 months","ALL","7 Years","65 Years",true,{"inclusion":70,"exclusion":76,"raw_text":80},[71,72,73,74,75],"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\u002Fweek 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\u002Fstudents: Include 1) boys and girls enrolled in 3rd - 6th grade at participating schools, 2) with parent\u002Fcaregiver consent, 3) regularly participating in the school-lunch program.","Parent\u002FCaregiver: 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.",[77,78,79],"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\u002Fcaregiver consent, do not provide assent, or do not participate in the school lunch program.","Parents\u002Fcaregivers will be excluded if they do not provide consent or cannot read or write in English or Spanish.","Inclusion Criteria:\n\n* Stores: Must be a Food City store located within the Maricopa or Pinal County regions.\n* 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\u002Fweek over the school year; and 4) are not participating in other FV related research.\n* 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.\n* Children\u002Fstudents: Include 1) boys and girls enrolled in 3rd - 6th grade at participating schools, 2) with parent\u002Fcaregiver consent, 3) regularly participating in the school-lunch program.\n* Parent\u002FCaregiver: 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.\n\nExclusion Criteria:\n\n* 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.\n* Students will be excluded if they are not enrolled in grades 3 through 6, do not have parent\u002Fcaregiver consent, do not provide assent, or do not participate in the school lunch program.\n* Parents\u002Fcaregivers will be excluded if they do not provide consent or cannot read or write in English or Spanish.",[82,83,84],"CHILD","ADULT","OLDER_ADULT",[86],{"facility":87,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":98},"Arizona Biomedical Collaberative","Phoenix","Arizona","85004","United States",[93],{"name":94,"role":95,"phone":96,"email":97},"Kristi Kristi Mollner, MS","CONTACT","480-965-5477","kristi.mollner@asu.edu",{"lat":99,"lon":100},33.44838,-112.07404,[102,106],{"name":103,"role":95,"phone":104,"email":105},"Marc A Adams, PhD, MPH","480-884-2544","marc.adams@asu.edu",{"name":107,"role":95,"phone":108,"email":109},"Punan Ohri-Vachaspati, PhD","480-884-2546","pohrivac@asu.edu",[111,113],{"name":103,"affiliation":12,"role":112},"PRINCIPAL_INVESTIGATOR",{"name":114,"affiliation":12,"role":112},"Punam Ohri-Vachaspati, PhD",[],[117],{"label":118,"url":119},"Related Info","https:\u002F\u002Fasufvstudy.org",{"nct_id":4,"conditions":121,"biomarkers":123},[122],"Healthy diet",[],{"nct_id":4,"found":68,"summary":125,"prompt_version":134},{"design":126,"status":127,"heading":6,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional pilot study with a planned enrollment of 880 participants. It compares two behavioral interventions: FFVP+ and FFVP-only.","completed","Arizona State University is conducting a pilot study to see if a program called FFVP+ can help children and their families eat more fruits and vegetables. FFVP+ is a partnership between elementary schools that already offer the USDA Fresh Fruit and Vegetable Program (FFVP) and nearby Bashas' Food City stores. The study will compare schools using FFVP+ with schools that only use the regular FFVP program. We want to see if this partnership can increase fruit and vegetable consumption. We'll measure this by looking at changes in skin carotenoid scores (a way to estimate fruit and vegetable intake) in children and their caregivers over about 8 to 9 months. Children aged 7 to 65 years can participate if their school and a nearby Food City store meet certain criteria in Maricopa or Pinal County.","Participants will be followed for approximately 8 to 9 months, from baseline to the end of the school year.",134,"Not specified in the trial record.","Not stated in the trial record.",[39],"v2"]