Type 2 DiabetesF4HNCT07254689
The Food for Health Study
A study testing Produce Prescription Program in people with Type 2 Diabetes and Food Insecurity, run by University of Montana at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Food Insecurity, Rural Health
- What is being tested?
- Produce Prescription Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals with end-stage renal disease
- Their health provider states they should not participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Arlee Health Center
Arlee, Montana, 59821
Taylor Steward Clinical Research Coordinator, MPH, 9134065334, taylor.stewart@mso.umt.edu
About this study
Official title: A Produce Prescription Program Aimed at Reducing Food Insecurity and Type 2 Diabetes Risk Among Native American Older Adults
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes, Food Insecurity, Rural Health
- Being tested
- Produce Prescription Program
- Keywords
- produce prescription program, Native American
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce Prescription ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Food for Health Healthy Food Prescription Intervention Arm | Experimental | Not described Receives: Behavioral: Produce Prescription Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: Pre (week 0), mid (week 8), post intervention (week 17)
Secondary outcomes (1)
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.
Measured: Pre (week 0), mid (week 8), post intervention (week 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Apr 2026
- Primary completion15 Feb 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Maja Pedersen, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254689
- Sponsor's protocol ID
- 58394712
- Other IDs
- P20GM130418
- Acronym
- F4H
- Status last verified
- Oct 2025
- First submitted
- 24 Sep 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will be shared based on the data sovereignty protocol developed by the Confederated Salish and Kootenai Tribes Research Review Board.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Produce Prescription Program Aimed at Reducing Food Insecurity and Type 2 Diabetes Risk Among Native American Older Adults
- ClinicalTrials.gov ID
- NCT07254689
- Acronym / sponsor ID
- F4H / 58394712
- Conditions
- Type 2 Diabetes, Food Insecurity, Rural Health
- Keywords
- produce prescription program, Native American
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food for Health Healthy Food Prescription Intervention Arm | Experimental | Behavioral: Produce Prescription Program |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Individuals with end-stage renal disease
- Their health provider states they should not participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Produce Prescription ProgramProduce 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. | Behavioural | Food for Health Healthy Food Prescription Intervention Arm |
Primary outcome
Intervention Feasibility Measure
Time frame: Time Frame: Pre (week 0), mid (week 8), post intervention (week 17)
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.
1 secondary outcome
U.S. Household Food Security Survey Module: Six-Item Short Form
Time frame: Pre (week 0), mid (week 8), post intervention (week 17)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. The IPD will be shared based on the data sovereignty protocol developed by the Confederated Salish and Kootenai Tribes Research Review Board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce Prescription Program in people with Type 2 Diabetes and Food Insecurity, run by University of Montana at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maja Pedersen, PhD (907-590-9694, maja.pedersen@mso.umt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility Measure (time frame: Time Frame: Pre (week 0), mid (week 8), post intervention (week 17)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.