The Food for Health Study
A Produce Prescription Program Aimed at Reducing Food Insecurity and Type 2 Diabetes Risk Among Native American Older Adults
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
Food for Health tests a program that gives vouchers for fruits, vegetables, and other healthy foods, plus food lessons based on Native culture. It is for Native American adults age 55 or older on Montana’s Flathead Reservation who have trouble getting enough food and meet diabetes-related requirements. The study will check whether the program helps people get enough food and improves blood sugar and weight.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 55 or older.
- Live on the Flathead Reservation.
- Identify as Native American.
- Have trouble getting enough food, based on two questions asked by a health provider.
- Have a diabetes diagnosis.
- Have prediabetes based on an HbA1c result of 5.7–6.4% (a test of average blood sugar), or score 5 or higher on the National Diabetes Prevention Program’s risk check.
Who can't join
- Have end-stage kidney disease, meaning the kidneys no longer work well enough.
- Your health provider says you should not take part.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. * Diabetes diagnosis * Pre-diabetic based on HbA1c lab results of (5.7-6.4%) or scores 5+ on the National Diabetes Prevention Programs screener based on health and history. Exclusion Criteria: * Individuals with end-stage renal disease * Their health provider states they should not participate
Study sites (1)
MT
- Arlee Health Center · Arlee, MT 59821Taylor Steward Clinical Research Coordinator, MPH · Study contact · 9134065334 · taylor.stewart@mso.umt.eduMore trials in Arlee