Feasibility of an Online-supported Delivery Program Bringing Nutritious Groceries to Households with Children at Risk for Food Insecurity (FOODBOX): A Study Protocol

Feasibility of an Online-supported Delivery Program Bringing Nutritious Groceries to Households with Children at Risk for Food Insecurity (FOODBOX): A Study Protocol | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Feasibility of an Online-supported Delivery Program Bringing Nutritious Groceries to Households with Children at Risk for Food Insecurity (FOODBOX): A Study Protocol Angela Trude, Rasheed Perry, Rachel Ingram, Kenny Escobar, Charmaine Ruddock, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6805911/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract Background : In 2023, one in five U.S. households with children experienced food insecurity, with Black and Hispanic households disproportionally affected. While programs like the Supplemental Nutrition Assistance Program (SNAP) provide grocery funds, many families still lack consistent access to nutritious foods due to structural barriers. To address these inequities, FOODBOX proposes an intervention informed by Food Is Medicine (FIM) to improve food and nutrition security among households of low-income with children. Leveraging existing online grocery technology (Instacart), the project will pilot a medically tailored grocery box delivery program in diverse New York City (NYC) neighborhoods. This paper describes the study protocol to assess the feasibility of delivering grocery boxes via community-based Federally Qualified Health Center Network (FQHCN) and Women, Infants, and Children (WIC) clinic. Methods : Formative research will be guided by the Ecological Validity Model to ensure culturally appropriate intervention design. Implementation science approaches will inform the evaluation of intervention fidelity and acceptability (primary feasibility outcomes), and preliminary effectiveness (secondary feasibility outcome) will be assessed though changes in household food security (USDA module) and fruit and vegetable intake (measured by skin carotenoid via Veggie Meter). Fidelity will be assessed by adherence to the intervention protocol in terms of recruitment, retention and compared to benchmarks set a priori. Acceptability will be evaluated through a post-intervention survey assessing satisfaction using Likert-scale and multiple-choice questions. We will enroll 30 households with young children at risk for food insecurity, collaborating with a FQHCN and a WIC clinic. Eligibility includes primary household shoppers with low income (i.e., Medicaid recipients, uninsured, SNAP participants, or those living below 130% of the federal poverty level), living with at least one child < age 10, screened positive for food insecurity, and with access to smartphones or computers for online orders. Discussion : This project, timely in its alignment with the current policy momentum, seeks to decentralize FIM approaches from healthcare systems and incorporate existing technology like Instacart to improve access to nutritious foods. By piloting innovative FIM interventions in community settings, the project seeks to inform evidence-based approaches and pave the way for a subsequent larger-scale intervention. Trial Registration : clinicaltrials.gov ID: NCT06870526. Registered 11 March 2025, https://clinicaltrials.gov/study/NCT06870526 Food Is Medicine Food security Nutrition security Online grocery Study Protocol Figures Figure 1 Figure 2 BACKGROUND Food insecurity, that is, the lack of consistent access to sufficient food for a healthy life,(1) is experienced by 13.5% of the U.S. population, with a higher prevalence among households with children (17.9%). (2-4) Families with children deserve special attention as growing up in a food insecure home can have a profound impact on morbidity and mortality,(5, 6) including increased cardiovascular disease risk later in life(7) potentially mediated through poor diet.(8) Racial and ethnic disparities in food insecurity persist, with Black (29%) and Hispanic (32%) households having the highest rates of food insecurity in the country.(4) Federal programs, like the Supplemental Nutrition Assistance Program (SNAP), which reaches over 41 million low-income families, provide grocery funds to alleviate the household budget.(9) Yet, many families still do not have consistent and equitable access to foods that promote optimal health, in other words, they experience nutrition insecurity. Low physical access to food retailers, higher prices for nutritious foods, and limited time for shopping and cooking have been identified as possible causal mechanisms explaining food and nutrition security inequities across ethnic and socio-economic groups.(10) To address these inequities in health, food-based strategies embedded into healthcare systems and population health have shown promise to reduce food insecurity and improve dietary intake and mental health.(11) These interventions are conceptualized through the Food Is Medicine (FIM) initiatives, and include medically tailored meals, medically tailored groceries, and produce prescription programs, among others. Despite promising improvements in nutrition security and cardiometabolic equity for these interventions (11), the literature on medically tailored groceries is still emerging, and robust evidence still lacking.(12) Challenges of FIM implementation may hinder their effectiveness,(13) including i) overburdening of physicians and healthcare staff due to enrollment through the healthcare system, ii) challenges for families with low income to connect with the healthcare system, and iii) low number of physicians and healthcare sites participating in medically tailored groceries programs. We will design, implement, and evaluate a pilot intervention of medically tailored grocery based in a community setting that serves primarily ethnically diverse families with low-income at risk for food insecurity. The proposed project, called FOODBOX is timely, aligning with policy momentum, such as the Medicaid 1115 waiver (14), and responding to the National Institutes of Health''s call for FIM research opportunities. Medicaid Section 1115 waiver allows states to test innovative approaches in Medicaid that differ from federal rules, such as support for food. Notably, this research addresses structural barriers by proposing a decentralized FIM pilot based in a community setting. Additionally, it incorporates existing technology in collaboration with Instacart, offering a contemporary and practical approach to bridge gaps in access to nutritious foods. The results of this pilot study have the potential to inform larger-scale interventions and contribute to the growing field of FIM research by incorporating implementation science measures (15). OBJECTIVES The primary objective of this study is to examine the feasibility of delivering nutritious grocery boxes via Instacart through community-based health organizations. Feasibility will be assessed against three a priori criteria defining acceptable levels, following guidelines for designing and evaluating feasibility trials (16): (i) receipt of the boxes, (ii) utilization of grocery items, and (iii) participant satisfaction. Secondary objectives are to examine participant recruitment, barriers to recruitment, the suitability of two candidate primary outcomes for a full-scale trial (i.e., food and nutrition security measures and fruit and vegetable intake estimated via skin carotenoid using Veggie Meter). More specifically, we aim to: 1) conduct formative research with a community engagement process to inform the intervention design and ensure foods are culturally appropriate; 2) apply implementation science approaches to evaluate the extent to which the intervention can be implemented in the intended setting exactly as evaluated; and 3) compare preliminary effectiveness in terms of household food security and fruit and vegetable intake. METHODS Design . This feasibility behavioral intervention will use a single-group, open label pre-post design implemented for 12 weeks targeting 30 households of low-income with children age 10 or younger at risk for food insecurity. The adapted SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist for reporting the protocol of a pilot study has been included as Supplemental File 1 . Ethical Approval . The study was approved by the Cornell University Institute of Review Board number IRB0010546 and by the New York University Institute of Review Board number IRB-FY2024-9113. Setting . The study will be conducted in low-income, diverse neighborhoods of New York City, specifically in the South Bronx. Selection was based on the highest poverty rates, obesity prevalence, and racial and ethnic diversity.(17) Participants . The study aims to recruit 30 participants. The sample size for the FOODBOX feasibility trial was determined based on budgetary constraints and participant flow. A total of 30 participants or less is acceptable in a feasibility studies focused on recruitment, adherence, and acceptability.(16) A conventional power calculation is not necessary since evaluating intervention effectiveness is not the aim of a pilot feasibility trial. The proposed sample size is sufficient to assess feasibility outcomes (e.g. utilization and satisfaction) and to estimate key parameters (e.g. the standard deviation of candidate behavioral outcomes)(18). The criteria for the recruitment and retention feasibility are 50% (95% Clopper Pearson Exact CI for one proportion, 31%, 68%) and 80% (95% CI, 61%, 92%), respectively. The criterion for fidelity is 90% (95% CI, 73%, 97%). Inclusion Criteria . To be eligible for the study, adult caregivers must: (i) reside the majority of the time with at least one child ( < age 10); (ii) have low-income defined as living at or below 130% of the 2025 federal poverty level or participation in the Supplemental Nutrition Assistance Program (SNAP) in the past 12 months; (iii) at risk for food insecurity as defined by the 18-item U.S. Household Food Security Model (HFSM) from the USDA or utilize emergency food services such as food pantries, soup kitchens, of food shelves often in the previous 12 months. Use of emergency food services were included as an option to capture risk for food insecurity to address limitations of the HFSM questionnaire and capture cultural variations in the experience of food insecurity.(19) All participants must speak either English or Spanish and have access to a smartphone or computer to engage in the intervention. Recruitment . Recruitment will be conducted in collaboration with the Institute for Family Health/Bronx Health REACH. The Institute for Family Health (IFH) is one of the largest federally-qualified health center (FQHC) networks in New York State (NYS) operating 27 health centers that provide primary care, behavioral health care, dental care and social support services to about 102,000 diverse residents of all ages annually, regardless of insurance status or ability to pay. The Institute leads the Center for Disease Control (CDC)-funded Bronx Health REACH (BHR) Coalition. Since 1999, BHR has engaged thousands of Bronx residents in a community-driven effort to eliminate entrenched health disparities in chronic disease and related risk factors among Black and Latin American residents of the South Bronx. The BHR Coalition now comprises over 80 organizations and agencies. Recruitment will take place at two community-based health centers in the Mount Hope area of the Bronx (in zip code 10453) and in the Soundview area of the Bronx (in zip code 10473) and at a WIC clinic within IFH (in zip code 10453). During the recruitment calls, BHR staff will read through the project’s recruitment script and will describe the intervention, eligibility, and instruct interested individuals to connect with the research team via text or email ( Supplemental File 2 ). The BHR database will not be shared with the study team to maintain individual’s data confidentiality agreements. At the WIC clinic, prospective participants will be recruited during the virtual breastfeeding support groups led by a lactation consultant. Once connected with a research assistant staff, prospective participants will receive a Qualtrics survey link with informed consent to verify eligibility and collect baseline demographic and contact information ( Supplemental File 3 ). Eligible participants will then meet with the research team in-person at a time that is convenient to them at one of the IFH health centers and the WIC clinic for assessment of dietary intake through the National Cancer Institute’s Fruit and Vegetable (NCI FV) Screener, psychosocial factors that may influence household food utilization (i.e., cooking skills and self-efficacy for healthy eating), and a Veggie Meter Ò . Participants unable to attend during standard hours will be offered alternative options as needed. In the in-person meeting, participants will receive additional information and instructions for the program and will be able to ask questions. Intervention materials including flyers, consent forms, survey questionnaires, and tailored SMS will be delivered in the participant’s preferred language. FOOD BOX Pilot Intervention Conceptual Model. This study is guided by a conceptual model adapted from Seligman et al. (2023) for exploring food and nutrition security(20) and is presented in Figure 1 . The framework recognizes that food and nutrition security is influenced by the social determinants of health, represented by the broadest three orange-shaded boxes framing food security. It also acknowledges that the social determinants of health can impact household nutrition security directly or indirectly via food security and in turn, both food and nutrition security influence health. The Food Is Medicine strategy adopted in this pilot aims to address systems, policies, and environmental factors that influence food and nutrition security by improving household choice and resources. Formative Research . The formative research plan for the pilot study includes the incorporation of two focus groups prior to the implementation of the program, each comprising a minimum of 6 participants. Focus groups will be conducted at IFH health centers and will last for about one hour. Participants will receive a $20 gift card for participating in the focus groups. The main goal of the focus group discussions is to inform the intervention design and ensure the foods offered are culturally acceptable and appropriate. To ensure cultural adaptation, this qualitative phase will be guided by the Ecological Validity Model, in which we will employ six of the eight areas of attention when delivering evidence-based intervention to diverse cultural groups, as well as domains of the Behavior Change Wheel(21) and the Theoretical Domains Framework(22): i) Language – we will seek feedback on materials used in the intervention, including appropriate literacy level of written materials in English and Spanish; ii) Persons – garner the level of comfort in being recruited for the study by students versus community members and explore points of “buy in”; iii) Metaphors - explore symbols and sayings that will resonate with participants; iv) Content – investigate types of grocery items needed and wanted to mitigate food and nutrition insecurity, as well as identify culturally appropriate items; v) Methods – gather feedback on the delivery of the communication (text message), measurements (online), and intervention (online); and vi) Context – explore barriers to participation and intervention adherence ( Table 1 ). Table 1. Cultural elements included in the focus group guide to inform the design of the pilot intervention. Cultural Element Description Behavior Change Wheel (21) and the Theoretical Domains Framework (22) Food Access Exploring current methods and challenges of accessing groceries. Physical Opportunity – Environmental Context and Resources Reflective Motivation – Beliefs about Capabilities Persons Roles and responsibilities for grocery shopping and meal planning within the household. Social Opportunity – Social Influence Metaphors Exploring cultural sayings and concepts related to food and nutrition. Reflective Motivation – Social Role & Identity Concepts Gathering perceptions on the idea of home delivery of grocery boxes. Reflective Motivation – Belief about Consequences Content Identifying important food items and suggestions for grocery boxes. Physical Opportunity – Environmental Context and Resources Context Influence of cultural, social, and economic contexts on grocery shopping and nutrition. Physical Opportunity – Environmental Context and Resources Communication and Recruitment Preferences for receiving information and effective recruitment methods. Automatic Motivation Language Importance and challenges of receiving information in preferred languages. Physical Opportunity – Environmental Context and Resources Barriers to Participation Potential barriers to participating in the grocery box delivery program. Psychological Capacity – Behavioral Regulation Delivery and Pickup Preferences for home delivery versus central pickup locations. Automatic Motivation The FOODBOX Pilot Implementation . Instacart Care Carts will be used for the FOODBOX pilot in which researchers order and deliver groceries on behalf of participants. Although participants are not able to modify the order, they can select when and where they want the grocery box delivered via Instacart app and receive notifications ( Figure 2 ). The content of the grocery box will be informed by findings from the formative research in conjunction with registered dietitians and nutritionists. Participants will receive fruits, vegetables, and legumes (fresh, frozen, and/or low-sodium low-sugar can), healthy starches, and grains for their household. The grocery boxes will be worth $25 each and delivered to the address that is most convenient to each participant for 12 weeks. Outcomes Primary Outcome : Feasibility. A benchmark (i.e., minimum acceptable values) was set a priori to indicate whether the pilot trial will be feasible and acceptable. Feasibility will be assessed as the ability of the research team to conduct a subsequent fully powered trial in terms of recruitment, intervention fidelity, and retention rates(16) ( Table 2 ). Acceptability will be assessed as participant satisfaction with the intervention materials via a post-intervention online survey among all participants with Likert-scale and multiple-choice questions. We will monitor intervention fidelity (i.e., extent the intervention-as-delivered matched the intervention-as-planned). This includes fidelity of the intervention protocol (recruitment, consistency with which the grocery boxes were delivered, and retention) and adaptations made to the initial protocol. Data will be collected systematically throughout the implementation of the intervention by trained research assistants. During the 12-week trial, we will conduct weekly meetings with staff to document barriers and facilitators of implementation; implement mid-course corrections of any deviations to the protocol; and systematically document any adaptations. Table 2 . Study measures in terms of feasibility and acceptability of the medically tailored online grocery box pilot to improve fruit and vegetable intake and food security among households of low-income with young children. Feasibility Measures Benchmark Recruitment # screened per week 10 # enrolled per week (completion of online survey + in-person Veggie Meter assessment) 5 Fidelity Proportion of the selected grocery (planned by the study team) delivered to participants (by Instacart shopper) 90% Number of grocery boxes delivered per week 30 Retention Adherence rate 80% Acceptability Text messaging Participants’ satisfaction with frequency and content Medium-High Grocery content Participants’ satisfaction with frequency, content, medium Medium-High Assessment Duration of online survey assessment < 20 min Secondary Outcomes: The two candidate primary outcomes for a full-scale trial (i.e., food security measures and fruit and vegetable intake) will be assessed via an online Qualtrics survey available in English and Spanish and in-person, respectively at baseline and immediately after the 12-week intervention. Household Food Security will be assessed using the 18-item Household Food Security Survey (USDA)(23) embedded in the Qualtrics survey, including the severity of food insecurity among adults (10 items; household-referenced dimension) and children (8 items; child-referenced dimension). This self-reported survey assesses worry about accessing food in terms of quantity, quality, and variety experienced by the caregiver, or another adult or child in the household in the past 12 months, answered by the primary caregiver. Household food security will be coded using recommended cut-points for household-referenced questions, ranging from 0 to 18 points: very low (eight or more affirmatives); low (three to seven); marginal (two to one); high (none). Fruit and Vegetable Intake will be estimated objectively as skin carotenoid via The Veggie Meter ® (VM) by Longevity Link Corporation, USA, which is a valid, objective, and noninvasive tool that estimates skin carotenoids in adults, using pressure-mediated reflection spectroscopy.(24) Carotenoids, predominantly found in fruit and vegetable, are readily deposited into body tissues, including the skin, making VM an innovative and reliable method for assessing change in fruit and vegetable intake in population-based research.(25-28) It is a repeatable, low race variability, long-term marker of fruit and vegetable intake, highly correlated with plasma carotenoid levels,(29, 30) and FFQ-estimated consumption in heterogeneous populations.(31) At least three finger scans will be conducted in-person with the adult caregiver by a study research staff at baseline and immediately after the 12-week intervention. The non-invasive nature and portability make it a particularly useful tool in community-based and real-world intervention studies targeting underserved populations. Data Analysis The research team will process quantitative data in Excel and Stata SE 16.1 and will analyze them using descriptive statistics (e.g., means, medians, standard deviations, frequencies and percentages). Guided by the SPIRIT Action Framework, feasibility and acceptability will be evaluated across multiple implementation domains; specifically, recruitment, retention, and intervention fidelity, and text messaging, grocery content, and assessment—using benchmarks established a priori ( Table 2 ). Each domain reflects a key indicator of the intervention’s implementation readiness. Feasibility and acceptability will each be categorized as high, medium, or low based on the average proportion of benchmarks met across all indicators. A high level (≥100% of benchmarks met) indicates strong readiness for scale-up; medium (50% to <100%) suggests partial feasibility or acceptability requiring refinement; and low (<50%) indicates limited feasibility or acceptability in the current form. While not all benchmarks must be met individually, the average across domains will inform judgments about the potential to proceed to a fully powered trial and the need for adaptation. Appropriate descriptive statistics will be used to summarize baseline participant socio-demographic data, the extent and pattern of missing data for behavioral outcomes (food insecurity and fruit and vegetable intake) at baseline and post-intervention, questionnaire completion rates (i.e. the number of individual items completed), variability in the responses across participants and floor/ceiling effects. As this is a feasibility study, no formal statistical tests comparing change over time will be conducted. No model-based imputation (e.g. multiple imputation) of missing data items will be attempted; missing data items will assume the mean value of all completed items on that measure for a particular individual (assuming that sufficient items have been completed). Qualitative feedback from open-ended survey questions and focus group transcripts will be analyzed thematically to explore participant experiences and inform future program improvements. Dissemination Findings will be shared with BHR community partners and the leadership and providers of Institute for Family Health, WIC, Instacart, policymakers at the NYC Mayor’s Office for Food Policy, and with participants in a summary report form and publicly in a community setting. In addition, it will also be shared at relevant academic conferences and published in peer-reviewed journal(s). DISCUSSION The current study aims to gather relevant information to plan, implement, and evaluate a subsequent full-scale and fully powered randomized controlled trial that will test the effectiveness of a medically tailored online grocery delivery program to households of low-income with children. This study is novel in its de-centralization of a Food is Medicine approach, from healthcare settings to community-based health clinics, as it addresses a barriers of low healthcare access among vulnerable populations related to lack of insurance, financial resources, and transportation. By integrating Instacart Care Carts with health center partnerships and allowing participants flexibility in delivery preferences, the intervention aims to demonstrate how technology and culturally tailored design can help to reduce barriers to access. The findings of this research have high likelihood of being translated into policy and applied to practice, given that some states are using Section 1115 waivers to cover nutrition services under Medicaid, particularly targeting chronic disease management and food insecurity. Another strength is the establishment of a partnership with a community-based coalition (Bronx Health REACH leadership) and engagement with community members to design the pilot to ensure the program is culturally acceptable. We have also identified several challenges and ways to address them. First, recruitment is often a challenge in community-based interventions targeted at underserved populations. Our experience recruiting underrepresented groups from community organizations and programs is a result of our strong, long-standing ties with those community-based organizations and enhances our ability to meet recruitment targets. This highlights the importance of trust-building strategies, such as multilingual materials and recruitment through familiar community sites, particularly for immigrant and Spanish-speaking households. Cultural tailoring efforts, guided by the Ecological Validity Model, also plays a critical role in enhancing the program’s relevance and acceptability. Participant feedback will inform the selection of grocery box contents and shape communication strategies, with an emphasis on familiar foods, convenience, and culturally resonant messaging. These lessons will provide important guidance for adapting FIM interventions to diverse, underserved populations and improving equity in access to nutritious foods. Despite these strengths, several implementation challenges may be anticipated. Enrollment will likely require sustained follow-up, particularly for families with limited digital access, variable schedules, or language barriers. While Instacart is expected to enhance convenience, potential issues such as item substitutions, missed deliveries, or limited product availability may require real-time troubleshooting by the research team. Additionally, challenges related to delivery coordination, such as participants not being home during scheduled windows or difficulties accessing certain buildings, could influence intervention fidelity. Food quality concerns, seasonal availability, and participant dissatisfaction with substitutions also require attention. To address these concerns, the study will implement proactive communication strategies, flexible scheduling options, and tracking procedures to support participant engagement and ensure consistent delivery of the intervention as intended. In conclusion, we anticipate that the current study, and our wider program of work, will contribute to the evidence base that will inform future FIM strategies. Our work can directly support policy recommendations for welfare programs, like Medicaid that have broad implications for the over 47 million people, including seven million children, experiencing food insecurity. This study also aligns with broader efforts to integrate non-clinical nutrition supports into Medicaid-managed care, WIC programming, and primary care settings. Findings from this pilot may inform policy models that support the inclusion of medically-tailored grocery interventions as reimbursable services within social and health safety nets. Our approach is significant and novel as it leverages existing and scalable technology to improve neighborhood food access among populations with low income. Abbreviations • BHR Bronx Health REACH • FFQ Food Frequency Questionnaire • FIM Food Is Medicine • FQHC Federally Qualified Health Center • HFSM Household Food Security Model • IFH The Institute for Family Health • NCI FV National Cancer Institute’s Fruit and Vegetable Screener • NYC New York City • NYS New York State • SNAP Supplemental Nutrition Assistance Program • USDA United States Department of Agriculture • VM Veggie Meter® • WIC Women, Infant, Child Nutrition Assistance Program Declarations Ethics approval and consent to participate : The study was approved by the Cornell University Institute of Review Board number IRB0010546 and by the New York University Institute of Review Board number IRB-FY2024-9113. Voluntary written informed consent will be obtained from participants prior to participation in the participant’s preferred language. Consent for publication : Not applicable. Availability of data and materials: The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request. Competing interests : The authors declare that they have no competing interests Funding: This study was funded in part by the Federal Capacity Funds, the National Institute of Food and Agriculture, US Department of Agriculture (2021−22−211). The funding agency was not involved in the conceptualization and implementation of the research study. Authors' contributions : ACBT and RF conceived the original idea and outline of the study, and ROP, RI, and KE, contributed to designing the study. ACBT, ROP, RI, KE, CR and RF wrote the study protocol. All authors discussed and commented on draft versions and approved the final version. Acknowledgements: We would like to thank Bronx Health Reach and the WIC clinics for their collaboration and efforts that informed the design of this study. 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A non-invasive assessment of skin carotenoid status through reflection spectroscopy is a feasible, reliable and potentially valid measure of fruit and vegetable consumption in a diverse community sample. Public Health Nutr. 2018;21(9):1664-70. Supplementary Files SupplementalFile1SPIRITChecklistFOODBOX.doc SupplementalFile2FoodboxRecruitmentScreeningScript.docx SupplementalFile3FOODBOXFeasibilityIRBconsent.pdf Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 22 Oct, 2025 Reviewers invited by journal 24 Jun, 2025 Editor assigned by journal 18 Jun, 2025 First submitted to journal 17 Jun, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6805911","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":475834961,"identity":"5fcc6a72-0416-4190-805c-0c065d9f144b","order_by":0,"name":"Angela Trude","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA5klEQVRIiWNgGAWjYLCCBxDKgOEDjEEQJDAwSIBUMs4gWQszDzFa+Ge3X3yQUMNQZz4jeeNj2x2HExvYm7dJ4NMicedMsUHCMQYJmRtpxca5Z4BaeI6V4dXCcCMnTSKBjUFCQiLHTDq3DagFyMCrRf5GTvqPhH9gLea/LUFa5N/g12JwI/0YQ2IbxBZmRrAtPPi1GN7IYZZI7JOQnMHzrFiyty3duI0nrdgCnxa5G+kPP3z4ZsMvwZ688cPPNmvZfvbDG2/g08LAwAOKBbhLmhnY8CsHAfYHyLw6whpGwSgYBaNgxAEAMi5G6yVTivEAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-2881-1089","institution":"New York University Steinhardt School of Culture Education and Human Development","correspondingAuthor":true,"prefix":"","firstName":"Angela","middleName":"","lastName":"Trude","suffix":""},{"id":475834962,"identity":"c9cb7890-f28a-4a0e-b77c-97e2b4449b30","order_by":1,"name":"Rasheed Perry","email":"","orcid":"","institution":"NYU Steinhardt: New York University Steinhardt School of Culture Education and Human Development","correspondingAuthor":false,"prefix":"","firstName":"Rasheed","middleName":"","lastName":"Perry","suffix":""},{"id":475834963,"identity":"1f9f78cc-fa6a-459c-a155-29e5b008c504","order_by":2,"name":"Rachel Ingram","email":"","orcid":"","institution":"The Institute for Family Health","correspondingAuthor":false,"prefix":"","firstName":"Rachel","middleName":"","lastName":"Ingram","suffix":""},{"id":475834964,"identity":"e6a09359-ffec-467d-9230-121610e8f3cf","order_by":3,"name":"Kenny Escobar","email":"","orcid":"","institution":"The Institute for Family Health","correspondingAuthor":false,"prefix":"","firstName":"Kenny","middleName":"","lastName":"Escobar","suffix":""},{"id":475834965,"identity":"e5dcf349-dfb2-47e0-b2f5-ed285a260869","order_by":4,"name":"Charmaine Ruddock","email":"","orcid":"","institution":"The Institute for Family Health","correspondingAuthor":false,"prefix":"","firstName":"Charmaine","middleName":"","lastName":"Ruddock","suffix":""},{"id":475834966,"identity":"3c0c6a33-e608-4974-b6e4-f940545ae29c","order_by":5,"name":"Roger Figueroa","email":"","orcid":"https://orcid.org/0000-0002-2549-7741","institution":"Cornell University Division of Nutritional Sciences","correspondingAuthor":false,"prefix":"","firstName":"Roger","middleName":"","lastName":"Figueroa","suffix":""}],"badges":[],"createdAt":"2025-06-03 01:52:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6805911/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6805911/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":85649010,"identity":"4ae2c7ba-3853-44c2-81f1-240ea9cf951b","added_by":"auto","created_at":"2025-06-30 08:54:41","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":93118,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6805911/v1/c7c44dd95bafb7029725fed8.png"},{"id":85648997,"identity":"59b0cab6-6b07-44ec-a884-e9b4e5ba4b40","added_by":"auto","created_at":"2025-06-30 08:54:39","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":90304,"visible":true,"origin":"","legend":"\u003cp\u003eFOODBOX pilot via Instacart Care Carts (participant interface).\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-6805911/v1/e213070ff3b417d84214085e.png"},{"id":86797179,"identity":"abaa8fe5-5421-426a-a3f0-15866f1ab144","added_by":"auto","created_at":"2025-07-15 15:56:01","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":896160,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6805911/v1/012e7837-91f2-4ea9-beaa-a8003246453f.pdf"},{"id":85648982,"identity":"f8b48e5c-5c40-488b-86db-aa0aa86cdf21","added_by":"auto","created_at":"2025-06-30 08:54:35","extension":"doc","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":124928,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementalFile1SPIRITChecklistFOODBOX.doc","url":"https://assets-eu.researchsquare.com/files/rs-6805911/v1/fa49488932b71050782de293.doc"},{"id":85649012,"identity":"a5e4ca04-88c6-4642-961f-5bf92510bb91","added_by":"auto","created_at":"2025-06-30 08:54:42","extension":"docx","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":2821549,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementalFile2FoodboxRecruitmentScreeningScript.docx","url":"https://assets-eu.researchsquare.com/files/rs-6805911/v1/87913c6322258df83fc04f8f.docx"},{"id":85649020,"identity":"6299c7da-36ea-492f-be34-a20a5f6fad83","added_by":"auto","created_at":"2025-06-30 08:54:43","extension":"pdf","order_by":6,"title":"","display":"","copyAsset":false,"role":"supplement","size":126533,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementalFile3FOODBOXFeasibilityIRBconsent.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6805911/v1/a589470d8b560e40ad98f86c.pdf"}],"financialInterests":"","formattedTitle":"Feasibility of an Online-supported Delivery Program Bringing Nutritious Groceries to Households with Children at Risk for Food Insecurity (FOODBOX): A Study Protocol","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003eFood insecurity, that is, the lack of consistent access to sufficient food for a healthy life,(1) is experienced by 13.5% of the U.S. population, with a higher prevalence among households with children (17.9%).\u003csup\u003e(2-4)\u003c/sup\u003e Families with children deserve special attention as growing up in a food insecure home can have a profound impact on morbidity and mortality,(5, 6)\u0026nbsp;including increased cardiovascular disease risk later in life(7)\u0026nbsp;potentially mediated through poor diet.(8)\u0026nbsp;Racial and ethnic disparities in food insecurity persist, with Black (29%) and Hispanic (32%) households having the highest rates of food insecurity in the country.(4)\u0026nbsp;Federal programs, like the Supplemental Nutrition Assistance Program (SNAP), which reaches over 41 million low-income families, provide grocery funds to alleviate the household budget.(9)\u0026nbsp;Yet, many families still do not have consistent and equitable access to foods that promote optimal health, in other words, they experience nutrition insecurity. Low physical access to food retailers, higher prices for nutritious foods, and limited time for shopping and cooking have been identified as possible causal mechanisms explaining food and nutrition security inequities across ethnic and socio-economic groups.(10)\u003c/p\u003e\n\u003cp\u003eTo address these inequities in health, food-based strategies embedded into healthcare systems and population health have shown promise to reduce food insecurity and improve dietary intake and mental health.(11) These interventions are conceptualized through the Food Is Medicine (FIM) initiatives, and include medically tailored meals, medically tailored groceries, and produce prescription programs, among others. Despite promising improvements in nutrition security and cardiometabolic equity for these interventions (11), the literature on medically tailored groceries is still emerging, and robust evidence still lacking.(12) Challenges of FIM implementation may hinder their effectiveness,(13) including i) overburdening of physicians and healthcare staff due to enrollment through the healthcare system, ii) challenges for families with low income to connect with the healthcare system, and iii) low number of physicians and healthcare sites participating in medically tailored groceries programs.\u003c/p\u003e\n\u003cp\u003eWe will design, implement, and evaluate a pilot intervention of medically tailored grocery based in a community setting that serves primarily ethnically diverse families with low-income at risk for food insecurity. The proposed project, called FOODBOX is timely, aligning with policy momentum, such as the Medicaid 1115 waiver (14), and responding to the National Institutes of Health''s call for FIM research opportunities. Medicaid Section 1115 waiver\u0026nbsp;allows states to test innovative approaches in Medicaid that differ from federal rules, such as support for food. Notably, this research addresses structural barriers by proposing a decentralized FIM pilot based in a community setting. Additionally, it incorporates existing technology in collaboration with Instacart, offering a contemporary and practical approach to bridge gaps in access to nutritious foods. The results of this pilot study have the potential to inform larger-scale interventions and contribute to the growing field of FIM research by incorporating implementation science measures (15).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOBJECTIVES\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary objective of this study is to examine the feasibility of delivering nutritious grocery boxes via Instacart through community-based health organizations. Feasibility will be assessed against three a priori criteria defining acceptable levels, following guidelines for designing and evaluating feasibility trials (16): \u0026nbsp;(i) receipt of the boxes, (ii) utilization of grocery items, and (iii) participant satisfaction. Secondary objectives are to examine participant recruitment, barriers to recruitment, the suitability of two candidate primary outcomes for a full-scale trial (i.e., food and nutrition security measures and fruit and vegetable intake estimated via skin carotenoid using Veggie Meter). More specifically, we aim to: 1) conduct formative research with a community engagement process to inform the intervention design and ensure foods are culturally appropriate; 2) apply implementation science approaches to evaluate the extent to which the intervention can be implemented in the intended setting exactly as evaluated; and 3) compare preliminary effectiveness in terms of household food security and fruit and vegetable intake. \u0026nbsp;\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDesign\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e.\u0026nbsp;\u003c/strong\u003eThis feasibility behavioral intervention will use a single-group, open label pre-post design implemented for 12 weeks targeting 30 households of low-income with children age 10 or younger at risk for food insecurity. The adapted SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist for reporting the protocol of a pilot study has been included as \u003cstrong\u003eSupplemental File 1\u003c/strong\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthical Approval\u003c/em\u003e\u003c/strong\u003e. The study was approved by the Cornell University Institute of Review Board number IRB0010546 and by the New York University Institute of Review Board number IRB-FY2024-9113.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSetting\u003c/em\u003e\u003c/strong\u003e. The study will be conducted in low-income, diverse neighborhoods of New York City, specifically in the South Bronx. Selection was based on the highest poverty rates, obesity prevalence, and racial and ethnic diversity.(17)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eParticipants\u003c/em\u003e\u003c/strong\u003e. The study aims to recruit 30 participants. The sample size for the FOODBOX feasibility trial was determined based on budgetary constraints and participant flow. A total of 30 participants or less is acceptable in a feasibility studies focused on recruitment, adherence, and acceptability.(16)\u0026nbsp;A conventional power calculation is not necessary since evaluating intervention effectiveness is not the aim of a pilot feasibility trial. The proposed sample size is sufficient to assess feasibility outcomes (e.g. utilization and satisfaction) and to estimate key parameters (e.g. the standard deviation of candidate behavioral outcomes)(18). The criteria for the recruitment and retention feasibility are 50% (95% Clopper Pearson Exact CI for one proportion, 31%, 68%) and 80% (95% CI, 61%, 92%), respectively. The criterion for fidelity is 90% (95% CI, 73%, 97%).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eInclusion Criteria\u003c/em\u003e\u003c/strong\u003e. To be eligible for the study, adult caregivers must: (i) reside the majority of the time with at least one child (\u003cu\u003e\u0026lt;\u003c/u\u003e age 10); (ii) have low-income defined as living at or below 130% of the 2025 federal poverty level or participation in the Supplemental Nutrition Assistance Program (SNAP) in the past 12 months; (iii) at risk for food insecurity as defined by the 18-item U.S. Household Food Security Model (HFSM) from the USDA or utilize emergency food services such as food pantries, soup kitchens, of food shelves often in the previous 12 months. Use of emergency food services were included as an option to capture risk for food insecurity to address limitations of the HFSM questionnaire and capture cultural variations in the experience of food insecurity.(19) All participants must speak either English or Spanish and have access to a smartphone or computer to engage in the intervention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRecruitment\u003c/em\u003e\u003c/strong\u003e. Recruitment will be conducted in collaboration with the Institute for Family Health/Bronx Health REACH. The Institute for Family Health (IFH) is one of the\u003c/p\u003e\n\u003cp\u003elargest federally-qualified health center (FQHC) networks in New York State (NYS) operating 27 health centers that provide primary care, behavioral health care, dental care and social support services to about 102,000 diverse residents of all ages annually, regardless of insurance status or ability to pay. The Institute leads the Center for Disease Control (CDC)-funded Bronx Health REACH (BHR) Coalition. Since 1999, BHR has engaged thousands of Bronx residents in a community-driven effort to eliminate entrenched health disparities in chronic disease and related risk factors among Black and Latin American residents of the South Bronx. The BHR Coalition now comprises over 80 organizations and agencies. Recruitment will take place at two community-based health centers in the Mount Hope area of the Bronx (in zip code 10453) and in the Soundview area of the Bronx (in zip code 10473) and at a WIC clinic within IFH (in zip code 10453). During the recruitment calls, BHR staff will read through the project\u0026rsquo;s recruitment script and will describe the intervention, eligibility, and instruct interested individuals to connect with the research team via text or email (\u003cstrong\u003eSupplemental File 2\u003c/strong\u003e). The BHR database will not be shared with the study team to maintain individual\u0026rsquo;s data confidentiality agreements. At the WIC clinic, prospective participants will be recruited during the virtual breastfeeding support groups led by a lactation consultant. Once connected with a research assistant staff, prospective participants will receive a Qualtrics survey link with informed consent to verify eligibility and collect baseline demographic and contact information (\u003cstrong\u003eSupplemental File 3\u003c/strong\u003e). Eligible participants will then meet with the research team in-person at a time that is convenient to them at one of the IFH health centers and the WIC clinic for assessment of dietary intake through the National Cancer Institute\u0026rsquo;s Fruit and Vegetable (NCI FV) Screener, psychosocial factors that may influence household food utilization (i.e., cooking skills and self-efficacy for healthy eating), and a \u003cem\u003eVeggie Meter\u003c/em\u003e\u003csup\u003e\u0026Ograve;\u003c/sup\u003e. Participants unable to attend during standard hours will be offered alternative options as needed. In the in-person meeting, participants will receive additional information and instructions for the program and will be able to ask questions. Intervention materials including flyers, consent forms, survey questionnaires, and tailored SMS will be delivered in the participant\u0026rsquo;s preferred language.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFOOD BOX Pilot Intervention\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConceptual Model.\u0026nbsp;\u003c/em\u003eThis study is guided by a conceptual model adapted from Seligman et al. (2023) for exploring food and nutrition security(20) and is presented in \u003cstrong\u003eFigure 1\u003c/strong\u003e. The framework recognizes that food and nutrition security is influenced by the social determinants of health, represented by the broadest three orange-shaded boxes framing food security. It also acknowledges that the social determinants of health can impact household nutrition security directly or indirectly via food security and in turn, both food and nutrition security influence health. The Food Is Medicine strategy adopted in this pilot aims to address systems, policies, and environmental factors that influence food and nutrition security by improving household choice and resources.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFormative Research\u003c/em\u003e. The formative research plan for the pilot study includes the incorporation of two focus groups prior to the implementation of the program, each comprising a minimum of 6 participants. Focus groups will be conducted at IFH health centers and will last for about one hour. Participants will receive a $20 gift card for participating in the focus groups. The main goal of the focus group discussions is to inform the intervention design and ensure the foods offered are culturally acceptable and appropriate. To ensure cultural adaptation, this qualitative phase will be guided by the Ecological Validity Model, in which we will employ six of the eight areas of attention when delivering evidence-based intervention to diverse cultural groups, as well as domains of the Behavior Change Wheel(21) and the Theoretical Domains Framework(22): i) Language \u0026ndash; we will seek feedback on materials used in the intervention, including appropriate literacy level of written materials in English and Spanish; ii) Persons \u0026ndash; garner the level of comfort in being recruited for the study by students versus community members and explore points of \u0026ldquo;buy in\u0026rdquo;; iii) Metaphors - explore symbols and sayings that will resonate with participants; iv) Content \u0026ndash; investigate types of grocery items needed and wanted to mitigate food and nutrition insecurity, as well as identify culturally appropriate items; v) Methods \u0026ndash; gather feedback on the delivery of the communication (text message), measurements (online), and intervention (online); and vi) Context \u0026ndash; explore barriers to participation and intervention adherence (\u003cstrong\u003eTable 1\u003c/strong\u003e).\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"731\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 731px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable 1. Cultural elements included in the focus group guide to inform the design of the pilot intervention.\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCultural Element\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDescription\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 334px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eBehavior Change Wheel\u003c/strong\u003e\u003cstrong\u003e(21)\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;and the Theoretical Domains Framework\u003c/strong\u003e\u003cstrong\u003e(22)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFood Access\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003eExploring current methods and challenges of accessing groceries.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 334px;\"\u003e\n \u003cp\u003ePhysical Opportunity \u0026ndash; \u003cem\u003eEnvironmental Context and Resources\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eReflective Motivation \u0026ndash; \u003cem\u003eBeliefs about Capabilities\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePersons\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003eRoles and responsibilities for grocery shopping and meal planning within the household.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 334px;\"\u003e\n \u003cp\u003eSocial Opportunity \u0026ndash; \u003cem\u003eSocial Influence\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMetaphors\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003eExploring cultural sayings and concepts related to food and nutrition.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 334px;\"\u003e\n \u003cp\u003eReflective Motivation \u0026ndash; \u003cem\u003eSocial Role \u0026amp; Identity\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eConcepts\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003eGathering perceptions on the idea of home delivery of grocery boxes.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 334px;\"\u003e\n \u003cp\u003eReflective Motivation \u0026ndash; \u003cem\u003eBelief about Consequences\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eContent\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003eIdentifying important food items and suggestions for grocery boxes.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 334px;\"\u003e\n \u003cp\u003ePhysical Opportunity \u0026ndash; \u003cem\u003eEnvironmental Context and Resources\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eContext\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003eInfluence of cultural, social, and economic contexts on grocery shopping and nutrition.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 334px;\"\u003e\n \u003cp\u003ePhysical Opportunity \u0026ndash; Environmental Context and Resources\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCommunication and Recruitment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003ePreferences for receiving information and effective recruitment methods.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 334px;\"\u003e\n \u003cp\u003eAutomatic Motivation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eLanguage\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003eImportance and challenges of receiving information in preferred languages.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 334px;\"\u003e\n \u003cp\u003ePhysical Opportunity \u0026ndash; \u003cem\u003eEnvironmental Context and Resources\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eBarriers to Participation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003ePotential barriers to participating in the grocery box delivery program.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 334px;\"\u003e\n \u003cp\u003ePsychological Capacity \u0026ndash; \u003cem\u003eBehavioral Regulation\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDelivery and Pickup\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 282px;\"\u003e\n \u003cp\u003ePreferences for home delivery versus central pickup locations.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 334px;\"\u003e\n \u003cp\u003eAutomatic Motivation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003cem\u003eThe FOODBOX Pilot Implementation\u003c/em\u003e. Instacart Care Carts will be used for the FOODBOX pilot in which researchers order and deliver groceries on behalf of participants. Although participants are not able to modify the order, they can select when and where they want the grocery box delivered via Instacart app and receive notifications (\u003cstrong\u003eFigure 2\u003c/strong\u003e). The content of the grocery box will be informed by findings from the formative research in conjunction with registered dietitians and nutritionists. Participants will receive fruits, vegetables, and legumes (fresh, frozen, and/or low-sodium low-sugar can), healthy starches, and grains for their household. The grocery boxes will be worth $25 each and delivered to the address that is most convenient to each participant for 12 weeks.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ePrimary Outcome\u003c/em\u003e: \u003cstrong\u003eFeasibility.\u003c/strong\u003e A benchmark (i.e., minimum acceptable values) was set a priori to indicate whether the pilot trial will be feasible and acceptable. Feasibility will be assessed as the ability of the research team to conduct a subsequent fully powered trial in terms of recruitment, intervention fidelity, and retention rates(16) (\u003cstrong\u003eTable 2\u003c/strong\u003e).\u0026nbsp;\u003cstrong\u003eAcceptability\u0026nbsp;\u003c/strong\u003ewill be assessed as participant satisfaction with the intervention materials via a post-intervention online survey among all participants with Likert-scale and multiple-choice questions. We will monitor intervention fidelity (i.e., extent the intervention-as-delivered matched the intervention-as-planned). This includes fidelity of the intervention protocol (recruitment, consistency with which the grocery boxes were delivered, and retention) and adaptations made to the initial protocol. Data will be collected systematically throughout the implementation of the intervention by trained research assistants. During the 12-week trial, we will conduct weekly meetings with staff to document barriers and facilitators of implementation; implement mid-course corrections of any deviations to the protocol; and systematically document any\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eadaptations.\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"691\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"3\" style=\"width: 691px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable 2\u003c/strong\u003e. Study measures in terms of feasibility and acceptability of the medically tailored online grocery box pilot to improve fruit and vegetable intake and food security among households of low-income with young children.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFeasibility\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 402px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMeasures\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 109px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eBenchmark\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eRecruitment\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 402px;\"\u003e\n \u003cp\u003e# screened per week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 109px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 402px;\"\u003e\n \u003cp\u003e# enrolled per week (completion of online survey + in-person Veggie Meter assessment)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 109px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eFidelity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 402px;\"\u003e\n \u003cp\u003eProportion of the selected grocery (planned by the study team) delivered to participants (by Instacart shopper)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 109px;\"\u003e\n \u003cp\u003e90%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 402px;\"\u003e\n \u003cp\u003eNumber of grocery boxes delivered per week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 109px;\"\u003e\n \u003cp\u003e30\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eRetention\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 402px;\"\u003e\n \u003cp\u003eAdherence rate\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 109px;\"\u003e\n \u003cp\u003e80%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAcceptability\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 402px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 109px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eText messaging\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 402px;\"\u003e\n \u003cp\u003eParticipants\u0026rsquo; satisfaction with frequency and content\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 109px;\"\u003e\n \u003cp\u003eMedium-High\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eGrocery content\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 402px;\"\u003e\n \u003cp\u003eParticipants\u0026rsquo; satisfaction with frequency, content, medium\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 109px;\"\u003e\n \u003cp\u003eMedium-High\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eAssessment\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 402px;\"\u003e\n \u003cp\u003eDuration of online survey assessment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 109px;\"\u003e\n \u003cp\u003e\u003cu\u003e\u0026lt;\u003c/u\u003e 20 min\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cem\u003eSecondary Outcomes:\u0026nbsp;\u003c/em\u003eThe two candidate primary outcomes for a full-scale trial (i.e., food security measures and fruit and vegetable intake) will be assessed via an online Qualtrics survey available in English and Spanish and in-person, respectively at baseline and immediately after the 12-week intervention. \u003cstrong\u003eHousehold Food Security\u003c/strong\u003e will be assessed using the 18-item Household Food Security Survey (USDA)(23) embedded in the Qualtrics survey, including the severity of food insecurity among adults (10 items; household-referenced dimension) and children (8 items; child-referenced dimension). This self-reported survey assesses worry about accessing food in terms of quantity, quality, and variety experienced by the caregiver, or another adult or child in the household in the past 12 months, answered by the primary caregiver. Household food security will be coded using recommended cut-points for household-referenced questions, ranging from 0 to 18 points: very low (eight or more affirmatives); low (three to seven); marginal (two to one); high (none). \u003cstrong\u003eFruit and Vegetable Intake\u003c/strong\u003e will be estimated objectively as skin carotenoid via The \u003cem\u003eVeggie Meter\u003c/em\u003e\u003csup\u003e\u0026reg;\u003c/sup\u003e\u003cem\u003e\u0026nbsp;(VM)\u003c/em\u003e by Longevity Link Corporation, USA, which is a valid, objective, and noninvasive tool that estimates skin carotenoids in adults, using pressure-mediated reflection spectroscopy.(24) Carotenoids, predominantly found in fruit and vegetable, are readily deposited into body tissues, including the skin, making VM an innovative and reliable method for assessing change in fruit and vegetable intake in population-based research.(25-28) It is a repeatable, low race variability, long-term marker of fruit and vegetable intake, highly correlated with plasma carotenoid levels,(29, 30) and FFQ-estimated consumption in heterogeneous populations.(31) At least three finger scans will be conducted in-person with the adult caregiver by a study research staff at baseline and immediately after the 12-week intervention. The non-invasive nature and portability make it a particularly useful tool in community-based and real-world intervention studies targeting underserved populations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe research team will process quantitative data in Excel and Stata SE 16.1 and will analyze them using descriptive statistics (e.g., means, medians, standard deviations, frequencies and percentages). Guided by the SPIRIT Action Framework, feasibility and acceptability will be evaluated across multiple implementation domains; specifically, recruitment, retention, and intervention fidelity, and text messaging, grocery content, and assessment\u0026mdash;using benchmarks established \u003cem\u003ea priori\u0026nbsp;\u003c/em\u003e(\u003cstrong\u003eTable 2\u003c/strong\u003e). Each domain reflects a key indicator of the intervention\u0026rsquo;s implementation readiness. Feasibility and acceptability will each be categorized as high, medium, or low based on the average proportion of benchmarks met across all indicators. A high level (\u0026ge;100% of benchmarks met) indicates strong readiness for scale-up; medium (50% to \u0026lt;100%) suggests partial feasibility or acceptability requiring refinement; and low (\u0026lt;50%) indicates limited feasibility or acceptability in the current form. While not all benchmarks must be met individually, the average across domains will inform judgments about the potential to proceed to a fully powered trial and the need for adaptation.\u003c/p\u003e\n\u003cp\u003eAppropriate descriptive statistics will be used to summarize baseline participant socio-demographic data, the extent and pattern of missing data for behavioral outcomes (food insecurity and fruit and vegetable intake) at baseline and post-intervention, questionnaire completion rates (i.e. the number of individual items completed), variability in the responses across participants and floor/ceiling effects. As this is a feasibility study, no formal statistical tests comparing change over time will be conducted. No model-based imputation (e.g. multiple imputation) of missing data items will be attempted; missing data items will assume the mean value of all completed items on that measure for a particular individual (assuming that sufficient items have been completed). Qualitative feedback from open-ended survey questions and focus group transcripts will be analyzed thematically to explore participant experiences and inform future program improvements.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFindings will be shared with BHR community partners and the leadership and providers of Institute for Family Health, WIC, Instacart, policymakers at the NYC Mayor\u0026rsquo;s Office for Food Policy, and with participants in a summary report form and publicly in a community setting. In addition, it will also be shared at relevant academic conferences and published in peer-reviewed journal(s).\u0026nbsp;\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThe current study aims to gather relevant information to plan, implement, and evaluate a subsequent full-scale and fully powered randomized controlled trial that will test the effectiveness of a medically tailored online grocery delivery program to households of low-income with children. This study is novel in its de-centralization of a Food is Medicine approach, from healthcare settings to community-based health clinics, as it addresses a barriers of low healthcare access among vulnerable populations related to lack of insurance, financial resources, and transportation. By integrating Instacart Care Carts with health center partnerships and allowing participants flexibility in delivery preferences, the intervention aims to demonstrate how technology and culturally tailored design can help to reduce barriers to access. The findings of this research have high likelihood of being translated into policy and applied to practice, given that some states are using Section 1115 waivers to cover nutrition services under Medicaid, particularly targeting chronic disease management and food insecurity.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAnother strength is the establishment of a partnership with a community-based coalition (Bronx Health REACH leadership) and engagement with community members to design the pilot to ensure the program is culturally acceptable. We have also identified several challenges and ways to address them. First, recruitment is often a challenge in community-based interventions targeted at underserved populations. Our experience recruiting underrepresented groups from community organizations and programs is a result of our strong, long-standing ties with those community-based organizations and enhances our ability to meet recruitment targets. This highlights the importance of trust-building strategies, such as multilingual materials and recruitment through familiar community sites, particularly for immigrant and Spanish-speaking households.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCultural tailoring efforts, guided by the Ecological Validity Model, also plays a critical role in enhancing the program’s relevance and acceptability. Participant feedback will inform the selection of grocery box contents and shape communication strategies, with an emphasis on familiar foods, convenience, and culturally resonant messaging. These lessons will provide important guidance for adapting FIM interventions to diverse, underserved populations and improving equity in access to nutritious foods.\u003c/p\u003e\n\u003cp\u003eDespite these strengths, several implementation challenges may be anticipated. Enrollment will likely require sustained follow-up, particularly for families with limited digital access, variable schedules, or language barriers. While Instacart is expected to enhance convenience, potential issues such as item substitutions, missed deliveries, or limited product availability may require real-time troubleshooting by the research team. Additionally, challenges related to delivery coordination, such as participants not being home during scheduled windows or difficulties accessing certain buildings, could influence intervention fidelity. Food quality concerns, seasonal availability, and participant dissatisfaction with substitutions also require attention. To address these concerns, the study will implement proactive communication strategies, flexible scheduling options, and tracking procedures to support participant engagement and ensure consistent delivery of the intervention as intended.\u003c/p\u003e\n\u003cp\u003eIn conclusion, we anticipate that the current study, and our wider program of work, will contribute to the evidence base that will inform future FIM strategies. Our work can directly support policy recommendations for welfare programs, like Medicaid that have broad implications for the over 47 million people, including seven million children, experiencing food insecurity. This study also aligns with broader efforts to integrate non-clinical nutrition supports into Medicaid-managed care, WIC programming, and primary care settings. Findings from this pilot may inform policy models that support the inclusion of medically-tailored grocery interventions as reimbursable services within social and health safety nets. Our approach is significant and novel as it leverages existing and scalable technology to improve neighborhood food access among populations with low income.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eBHR\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBronx Health REACH\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eFFQ\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFood Frequency Questionnaire\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eFIM\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFood Is Medicine\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eFQHC\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFederally Qualified Health Center\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eHFSM\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHousehold Food Security Model\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eIFH\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eThe Institute for Family Health\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eNCI FV\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNational Cancer Institute\u0026rsquo;s Fruit and Vegetable Screener\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eNYC\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNew York City\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eNYS\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNew York State\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eSNAP\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSupplemental Nutrition Assistance Program\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eUSDA\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eUnited States Department of Agriculture\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eVM\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eVeggie Meter\u0026reg;\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u0026bull; \u003cb\u003eWIC\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eWomen, Infant, Child Nutrition Assistance Program\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e:\u0026nbsp;The study was approved by the Cornell University Institute of Review Board number IRB0010546 and by the New York University Institute of Review Board number IRB-FY2024-9113. Voluntary written informed consent will be obtained from participants prior to participation in the participant’s preferred language.\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eConsent for publication\u003c/em\u003e: Not applicable.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eAvailability of data and materials:\u003c/em\u003e The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eCompeting interests\u003c/em\u003e: The authors declare that they have no competing interests\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eFunding:\u003c/em\u003e This study was funded in part by the Federal Capacity Funds, the National Institute of Food and Agriculture, US Department of Agriculture (2021−22−211). The funding agency was not involved in the conceptualization and implementation of the research study.\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eAuthors' contributions\u003c/em\u003e:\u0026nbsp;ACBT and RF conceived the original idea and outline of the study, and ROP, RI, and KE, contributed to designing the study. ACBT, ROP, RI, KE, CR and RF wrote the study protocol. All authors discussed and commented on draft versions and approved the final version.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eAcknowledgements: We would like to thank Bronx Health Reach and the WIC clinics for their collaboration and efforts that informed the design of this study.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eUnited States Department of Agriculture. Definitions of food security 2022 [Available from: https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-u-s/definitions-of-food-security/.\u003c/li\u003e\n \u003cli\u003eUSDA ERS. Key Statistics \u0026amp; Demographics [Internet] 2021 [Available from: https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-us/key-statistics-graphics.aspx#children.\u003c/li\u003e\n \u003cli\u003eBlumberg SJ, Bialostosky K, Hamilton WL, Briefel RR. The effectiveness of a short form of the Household Food Security Scale. American journal of public health. 1999;89(8):1231-4.\u003c/li\u003e\n \u003cli\u003eUrban Institute. Food Insecurity Trended Upward in Midst of High Inflation and Fewer Supports. Washington, DC: Urban Institute; 2022.\u003c/li\u003e\n \u003cli\u003eHayman LL, Worel JN. Reducing Disparities in Cardiovascular Health: Social Determinants Matter. J Cardiovasc Nurs. 2016;31(4):288-90.\u003c/li\u003e\n \u003cli\u003eSun Y, Liu B, Rong S, Du Y, Xu G, Snetselaar LG, et al. Food Insecurity Is Associated With Cardiovascular and All-Cause Mortality Among Adults in the United States. J Am Heart Assoc. 2020;9(19):e014629.\u003c/li\u003e\n \u003cli\u003eVercammen KA, Moran AJ, McClain AC, Thorndike AN, Fulay AP, Rimm EB. Food Security and 10-Year Cardiovascular Disease Risk Among U.S. Adults. American Journal of Preventive Medicine. 2019;56(5):689-97.\u003c/li\u003e\n \u003cli\u003ePalakshappa D, Ip EH, Berkowitz SA, Bertoni AG, Foley KL, Miller DP, et al. Pathways by Which Food Insecurity Is Associated With Atherosclerotic Cardiovascular Disease Risk. Journal of the American Heart Association. 2021;10(22):e021901.\u003c/li\u003e\n \u003cli\u003eUSDA. Supplemental Nutrition Assistance Program: Number of Persons Participating. 2021.\u003c/li\u003e\n \u003cli\u003eDarmon N, Drewnowski A. Does social class predict diet quality? The American Journal of Clinical Nutrition. 2008;87(5):1107-17.\u003c/li\u003e\n \u003cli\u003eMozaffarian D, Aspry KE, Garfield K, Kris-Etherton P, Seligman H, Velarde GP, et al. \u0026quot;Food Is Medicine\u0026quot; Strategies for Nutrition Security and Cardiometabolic Health Equity: JACC State-of-the-Art Review. J Am Coll Cardiol. 2024;83(8):843-64.\u003c/li\u003e\n \u003cli\u003eVolpp KG, Berkowitz SA, Sharma SV, Anderson CAM, Brewer LC, Elkind MSV, et al. Food Is Medicine: A Presidential Advisory From the American Heart Association. Circulation. 2023;148(18):1417-39.\u003c/li\u003e\n \u003cli\u003eMoran AJ, Roberto CA. A \u0026quot;Food Is Medicine\u0026quot; Approach to Disease Prevention: Limitations and Alternatives. JAMA. 2023;330(23):2243-4.\u003c/li\u003e\n \u003cli\u003eSociety of Behavioral Medicine. Federal Food is Medicine Funding. 2025.\u003c/li\u003e\n \u003cli\u003eFigueroa R, Houghtaling B. Food is Medicine and implementation science: A recipe for health equity. Transl Behav Med. 2024;14(4):234-40.\u003c/li\u003e\n \u003cli\u003eTeresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022;60(1):95-103.\u003c/li\u003e\n \u003cli\u003eDescribing the Food Environment in the South Bronx Neighborhood of Crotona-Tremont. New York City Department of Health and Mental Hygiene; 2014. Contract No.: No. 44.\u003c/li\u003e\n \u003cli\u003eIn J. Introduction of a pilot study. Korean J Anesthesiol. 2017;70(6):601-5.\u003c/li\u003e\n \u003cli\u003eNieves C, Dannefer R, Zamula A, Sacks R, Ballesteros Gonzalez D, Zhao F. \u0026quot;Come with us for a week, for a month, and see how much food lasts for you:\u0026quot; A Qualitative Exploration of Food Insecurity in East Harlem, New York City. J Acad Nutr Diet. 2022;122(3):555-64.\u003c/li\u003e\n \u003cli\u003eSeligman HK, Levi R, Adebiyi VO, Coleman-Jensen A, Guthrie JF, Frongillo EA. Assessing and Monitoring Nutrition Security to Promote Healthy Dietary Intake and Outcomes in the United States. Annual Review of Nutrition. 2023;43(1):409-29.\u003c/li\u003e\n \u003cli\u003eMichie S, van Stralen MM, West R. The behaviour change wheel: A new method for characterising and designing behaviour change interventions. Implementation Science. 2011;6(1):42.\u003c/li\u003e\n \u003cli\u003eAtkins L, Francis J, Islam R, O\u0026rsquo;Connor D, Patey A, Ivers N, et al. A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems. Implementation Science. 2017;12(1):77.\u003c/li\u003e\n \u003cli\u003eUS Department of Agriculture Economic Research Service. US household food security survey module 2012 [cited 2022 February 11]. Available from: https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-u-s/survey-tools/#household.\u003c/li\u003e\n \u003cli\u003eRadtke MD, Poe M, Stookey J, Jilcott Pitts S, Moran NE, Landry MJ, et al. Recommendations for the Use of the Veggie Meter\u0026reg; for Spectroscopy-Based Skin Carotenoid Measurements in the Research Setting. Current Developments in Nutrition. 2021;5(8):nzab104.\u003c/li\u003e\n \u003cli\u003eRadtke MD, Pitts SJ, Jahns L, Firnhaber GC, Loofbourrow BM, Zeng A, et al. Criterion-Related Validity of Spectroscopy-Based Skin Carotenoid Measurements as a Proxy for Fruit and Vegetable Intake: A Systematic Review. Advances in Nutrition. 2020;11(5):1282-99.\u003c/li\u003e\n \u003cli\u003eErmakov IV, Gellermann W. Optical detection methods for carotenoids in human skin. Arch Biochem Biophys. 2015;572:101-11.\u003c/li\u003e\n \u003cli\u003eNguyen LM, Scherr RE, Linnell JD, Ermakov IV, Gellermann W, Jahns L, et al. Evaluating the relationship between plasma and skin carotenoids and reported dietary intake in elementary school children to assess fruit and vegetable intake. Archives of Biochemistry and Biophysics. 2015;572:73-80.\u003c/li\u003e\n \u003cli\u003eScherr RE, Laugero KD, Graham DJ, Cunningham BT, Jahns L, Lora KR, et al. Innovative Techniques for Evaluating Behavioral Nutrition Interventions. Advances in Nutrition. 2017;8(1):113-25.\u003c/li\u003e\n \u003cli\u003eJahns L, Johnson LK, Mayne ST, Cartmel B, Picklo MJ, Sr., Ermakov IV, et al. Skin and plasma carotenoid response to a provided intervention diet high in vegetables and fruit: uptake and depletion kinetics. The American Journal of Clinical Nutrition. 2014;100(3):930-7.\u003c/li\u003e\n \u003cli\u003eStahl W, Heinrich U, Jungmann H, von Laar J, Schietzel M, Sies H, et al. Increased dermal carotenoid levels assessed by noninvasive reflection spectrophotometry correlate with serum levels in women ingesting Betatene. J Nutr. 1998;128(5):903-7.\u003c/li\u003e\n \u003cli\u003eJilcott Pitts SB, Jahns L, Wu Q, Moran NE, Bell RA, Truesdale KP, et al. A non-invasive assessment of skin carotenoid status through reflection spectroscopy is a feasible, reliable and potentially valid measure of fruit and vegetable consumption in a diverse community sample. Public Health Nutr. 2018;21(9):1664-70.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Food Is Medicine, Food security, Nutrition security, Online grocery, Study Protocol","lastPublishedDoi":"10.21203/rs.3.rs-6805911/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6805911/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: In 2023, one in five U.S. households with children experienced food insecurity, with Black and Hispanic households disproportionally affected. While programs like the Supplemental Nutrition Assistance Program (SNAP) provide grocery funds, many families still lack consistent access to nutritious foods due to structural barriers. To address these inequities, FOODBOX proposes an intervention informed by Food Is Medicine (FIM) to improve food and nutrition security among households of low-income with children. Leveraging existing online grocery technology (Instacart), the project will pilot a medically tailored grocery box delivery program in diverse New York City (NYC) neighborhoods.\u0026nbsp;This paper describes the study protocol to assess the feasibility of delivering grocery boxes via community-based Federally Qualified Health Center Network (FQHCN) and Women, Infants, and Children (WIC) clinic.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: Formative research will be guided by the\u0026nbsp;Ecological Validity Model to ensure culturally appropriate intervention design.\u0026nbsp;Implementation science approaches will inform the evaluation of intervention fidelity and acceptability (primary feasibility outcomes), and preliminary effectiveness (secondary feasibility outcome) will be assessed though changes in household food security (USDA module) and fruit and vegetable intake (measured by skin carotenoid via Veggie Meter).\u0026nbsp;Fidelity will be assessed by adherence to the intervention protocol in terms of recruitment, retention and compared to benchmarks set a priori. Acceptability will be evaluated through a post-intervention survey assessing satisfaction using Likert-scale and multiple-choice questions. We will enroll 30 households with young children at risk for food insecurity, collaborating with a FQHCN and a WIC clinic. Eligibility includes primary household shoppers with low income (i.e., Medicaid recipients, uninsured, SNAP participants, or those living below 130% of the federal poverty level), living with at least one child \u0026lt; age 10, screened positive for food insecurity, and with access to smartphones or computers for online orders.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e: This project, timely in its alignment with the current policy momentum, seeks to decentralize FIM approaches from healthcare systems and incorporate existing technology like Instacart to improve access to nutritious foods. By piloting innovative FIM interventions in community settings, the project seeks to inform evidence-based approaches and pave the way for a subsequent larger-scale intervention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Registration\u003c/strong\u003e: clinicaltrials.gov ID: NCT06870526. Registered 11 March 2025, https://clinicaltrials.gov/study/NCT06870526\u003c/p\u003e","manuscriptTitle":"Feasibility of an Online-supported Delivery Program Bringing Nutritious Groceries to Households with Children at Risk for Food Insecurity (FOODBOX): A Study Protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-06-30 08:53:26","doi":"10.21203/rs.3.rs-6805911/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-10-22T15:45:58+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-06-24T14:50:53+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-06-18T12:58:56+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pilot and Feasibility Studies","date":"2025-06-17T16:58:38+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"c0cc35c3-9c7d-4a92-8236-8dc0d9666eee","owner":[],"postedDate":"June 30th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-07-15T15:48:14+00:00","versionOfRecord":[],"versionCreatedAt":"2025-06-30 08:53:26","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6805911","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6805911","identity":"rs-6805911","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}