The project, called Food for Health (F4H), will study a new Produce Prescription Program (PPP) designed for rural Native American older adults. The study is based in the Confederated Salish and Kootenai Tribes (CSKT) of the Flathead Indian Reservation in Montana. In this community, many older adults face food insecurity and higher risk for Type 2 Diabetes (T2D). The tribal health department (THD) and local Food Resource Center (FRC) already provide important health and food support services, and this project builds on these strengths. Produce Prescription Programs (PPPs) is a type of nutrition support intervention that connects healthcare providers with local food programs to help patients access fresh, healthy foods. For example, an individual enrolled in the study will be "prescribe" fruits and vegetables in the form of a vouchers or coupons, which can be used to buy these foods at local food centers. Research shows that this type of program can reduce food insecurity, improve diet, and support better health. PPPs also fit well with tribal community priorities by supporting food sovereignty, culture-based nutrition education, and a stronger local food system. A key part of the study approach is using Community-Based Participatory Research (CBPR). CBPR means that community members, health providers, and researchers work together as equal partners. This way, the program is not just designed "for" the community, but "with" the community. The CSKT THD and community members have been involved in shaping this project from the start, and their priorities-like food security and food sovereignty-are at the center of the work. The investigators will carry out the study in two phases. Phase 1: Investigators will pilot test the acceptability of F4H in a small group of older adults (N=10) to understand the program's acceptability. The results will be used to refine and improve the program before moving to the next phase. Phase 2: Investigators will test the feasibility and impact of the refined F4H program with a larger group of older adults (N=33). Participant food insecurity and T2D risk factors, such as blood sugar and weight, will be measured before and after the program. Investigators expect that participants will have less food insecurity and healthier measures after completing the program. The clinic-to-community model is central to F4H. The THD will provide the prescriptions, and the FRC will be where participants redeem vouchers for fruits, vegetables, and other nutritious foods. The program will also include nutrition education that is grounded in Native culture and values. This model helps strengthen connections between healthcare and community services, creating a more supportive system for older adults. In addition to testing the program, investigators will study how it is carried out. This is called implementation research. It means paying attention to how the program fits into the community setting, what helps it succeed, and what barriers might need to be addressed. Understanding these factors is important so that the program can continue in the future and potentially be expanded to other Native communities. The long-term goal of F4H is to empower Native American communities to improve nutrition and reduce health disparities. By supporting older adults in gaining better access to healthy foods, the aim is to lower diabetes risk, improve quality of life, and strengthen local food systems. If the program is successful, it can serve as a model for other rural communities facing similar challenges.
Study Design - Food for Health (F4H) Type 2 diabetes (T2D) and food insecurity disproportionately affect Native American (NA) populations. These inequities are closely tied to the social determinants of health (SDOH), including limited access to affordable, nutritious foods. Food insecurity among NAs is approximately 20% higher than among non-Hispanic Whites, reflecting structural inequities rooted in the long-term impacts of colonization, forced relocation, and the disruption of traditional food systems. In response, many tribal communities are prioritizing food sovereignty, food security, and culturally relevant health interventions to address these disparities. Produce Prescription Programs (PPPs) represent an evidence-based intervention (EBI) that directly addresses food insecurity by linking higher risk patients with access to healthy foods. Through provider-issued prescriptions, patients receive vouchers redeemable at local food outlets for fruits, vegetables, and other nutritious items. PPPs reduce barriers to healthy eating, improve diet quality, and demonstrate promise in reducing risk for chronic disease. Importantly, PPPs align well with NA community priorities to strengthen local food systems and advance culture-centered nutrition education. However, little research has examined PPP effectiveness among rural NA older adults, a critical gap given their elevated risk for T2D and underrepresentation in nutrition and implementation research. The Food for Health (F4H) intervention aims to fill this gap. F4H is a clinic-to-community PPP designed for rural NA older adults and co-developed with the Confederated Salish and Kootenai Tribes (CSKT) of the Flathead Indian Reservation in Montana. The intervention will connect the tribal health department (THD) with a local Food Resource Center (FRC) to enhance access to fresh produce and strengthen community-based nutrition supports. A unique feature of this study is its community-based participatory research (CBPR) framework, which ensures that the intervention is designed, implemented, and evaluated in collaboration with community partners and responsive to tribal priorities such as food security and sovereignty. The study will be conducted in two phases. Phase 1 (Aim 1): Assess the acceptability of F4H and identify implementation determinants. Ten older adult participants (N=10) will engage in the intervention, and ten key informants (N=10) from the THD and FRC will participate in interviews. Data will provide insight into participant experiences, cultural appropriateness, and organizational readiness. Results will refine the intervention protocol and implementation plan to ensure alignment with community needs and context. Phase 2 (Aim 2): Evaluate the feasibility, implementation strategies, and preliminary effectiveness of the refined F4H intervention in a larger sample of rural NA older adults (N=33). Key outcomes include changes in food insecurity and T2D risk factors (e.g., weight, blood glucose) measured pre- and post-intervention. Investigators hypothesize that participants will experience reduced food insecurity and improved T2D risk indicators immediately following the intervention. The F4H model will be studied using implementation research methods, which prioritize understanding how EBIs can be integrated into real-world public health practice. This includes assessing contextual facilitators and barriers, stakeholder engagement, and sustainability potential. By embedding F4H in existing community and healthcare infrastructure, the project builds capacity for long-term impact and scalability within NA communities. The long-term goal of this research is to empower rural NA communities to strengthen food systems, enhance access to healthy foods, and reduce the disproportionate burden of T2D among older adults. By combining evidence-based intervention strategies with a CBPR framework, this study addresses a significant gap in nutrition and implementation research and provides a foundation for larger-scale trials. If effective, F4H has the potential to serve as a scalable model for addressing food insecurity and chronic disease prevention in tribal communities nationwide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
43
Produce Prescription Programs (PPPs) are an upstream evidence-based intervention (EBI) to reduce food insecurity and improve health. PPPs connect healthcare services (via provider prescriptions) to vouchers for free healthy food at Food Resource Centers (FRC) to enhance access and promote healthy eating among patients. For this study the PPP will be referred to as The Food for Health (F4H) intervention and will use a clinic-to-community model to link a tribal health dept. (THD) to a local FRC through the development of new collaboration and programming. The clinic-to-community model builds local capacity for synergy across healthcare and community-based entities to address unmet health and social needs.
Intervention Feasibility Measure
A brief 5-minute Likert-style survey including items for Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Each scale includes five items and has demonstrated content, discriminant, and structural validity, as well as reliability and responsiveness to change. AIM (Acceptability): Rates the extent to which the intervention is viewed as agreeable or satisfactory (e.g., "F4H meets my approval"). IAM (Appropriateness): Assesses the perceived fit or suitability of the intervention (e.g., "F4H seems suitable"). FIM (Feasibility): Evaluates the extent to which the intervention can be successfully carried out (e.g., "F4H seems doable"). Mean scores are calculated across all items and averaged together for a composite score. Higher values indicating better outcomes, with a score of 3 or higher indicating that participants view the intervention as feasible.
Time frame: Time Frame: Pre (week 0), mid (week 8), post intervention (week 17)
U.S. Household Food Security Survey Module: Six-Item Short Form
Food security will be measured using the U.S. Household Food Security Survey Module: Six-Item Short Form (USDA, 2012). Participants respond to six questions assessing food access and affordability over the past 12 months. Affirmative responses are summed for a total score ranging from 0 to 6, with higher scores indicating greater food insecurity. Scores are categorized as high/marginal (0-1), low (2-4), or very low (5-6) food security and as binary categories, food secure (0-1) and food insecure (2-6). Assessments will occur via REDCap surveys. The binary outcome (secure vs. insecure), investigators will use a logistic model with pairwise comparisons.
Time frame: Pre (week 0), mid (week 8), post intervention (week 17)
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