About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 55 years or older
Live on the Flathead Reservation
Self-identify as Native American (NA)
Food insecurity, as determined using Hunger Vital Sign™, a two question screener asked by providers.
Disqualifiers
Individuals with end-stage renal disease
Their health provider states they should not participate
Trial design
Single group
Treatments tested in this trial
Produce Prescription Program
BehavioralProduce 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Other outcomes
Glycated Hemoglobin (HbA1c)
Eligibility Criteria: Type 2 Diabetes (T2D) Diagnosis, or at-Risk for T2D (HbA1c or National DPP Screener) Eligible individuals must be classified as at risk for Type 2 Diabetes (T2D) based on one of the following criteria: Glycated Hemoglobin (HbA1c): A laboratory-measured HbA1c value between 5.7% and 6.4%, indicating prediabetes risk according to American Diabetes Association guidelines. National Diabetes Prevention Program (DPP) Screener: A score of 5 or higher on the CDC's National DPP Risk Test, based on self-reported health and lifestyle history. Glycated Hemoglobin (HbA1c): HbA1c will be measured using standardized laboratory procedures. HbA1c is reported as a percentage, scores range from normal (\<5.7%), prediabetes (5.7-6.4%), to diabetes (≥6.5%). Lower scores indicate better glycemic control. Continuous HbA1c values will be analyzed using a repeated measures ANOVA to examine within-participant changes across three time points (pre, mid, post) for one treatment group.
NCI Dietary Screener Questionnaire for Fruit & Vegetable Intake
Self-reported fruit and vegetable (F\&V) consumption will be collected using the NCI Dietary Screener Questionnaire, and will be administered via REDCap. This 10-item survey uses a 30-day reference period, converted to daily cup equivalent estimates of F\&V intake Scores are treated as a continuous variable, with higher values indicating greater intake and, therefore, a more favorable dietary outcome. Changes across time points will be analyzed using a repeated measures ANOVA for within-subject comparisons across the three assessment periods.
Sponsors and contacts
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University of Montana
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator