Recruiting

Produce Prescription Program

Sponsor:

University of Montana

Code:

NCT07254689

Conditions

Type 2 Diabetes

Food Insecurity

Rural Health

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Produce Prescription Program

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

Food Insecurity

Rural Health

Study ID

NCT07254689

Start date

Apr 1, 2026

Status verified date

Oct, 2025

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Feb 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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 Design

Enrollment

43 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Food for Health Healthy Food Prescription Intervention Arm

Interventions

Produce Prescription Program

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.

Primary outcome measure

  • Intervention Feasibility Measure [ Time Frame: Time Frame: Pre (week 0), mid (week 8), post intervention (week 17) ]

Central Contacts and Locations

Central contacts

Locations

Arlee Health Center

Recruiting

Arlee, Montana, United States, 59821

Contacts

Taylor Steward Clinical Research Coordinator, MPH

9134065334taylor.stewart@mso.umt.edu

More Information

Sponsor

University of Montana

Last update posted

Apr 3, 2026

Last verified

Oct, 2025

Keywords

  • produce prescription program
  • Native American

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Montana on 2026-04-03.