Type 2 DiabetesOKCICWCIE+NCT06077162
Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D
A study testing Diabetes Nutrition Education Classes and Healthy Food Security Resource in people with Type 2 Diabetes, run by Colorado State University at 1 site in United States.
Trial summary
Healthy nutrition habits are key to managing type 2 diabetes (T2D). However, American Indian and Alaska Natives (AI/ANs) often lack access to culturally relevant nutrition education and they disproportionately experience food insecurity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diabetes Nutrition Education Classes and Healthy Food Security Resource
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dx type 2 diabetes; American Indian or Alaska Native; fluent in English
Who cannot join
- Planned move within the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma City Indian Clinic
Oklahoma City, Oklahoma, 73127
About this study
Official title: Diabetes Nutrition Education (What Can I Eat? [WCIE]) and Healthy Food Resource for American Indians and Alaska Natives With T2D
Healthy nutrition habits are key to managing type 2 diabetes (T2D). However, American Indian and Alaska Natives (AI/ANs) often lack access to culturally relevant nutrition education and they disproportionately experience food insecurity. Food insecurity, defined as lack of consistent access to enough food for an active, healthy life, negatively impacts one's ability to engage in diabetes self-management and care. The purpose of this study is to evaluate if diabetes nutrition education and an added food security resource, such as farmers market vouchers for fruits and vegetables, can improve diabetes self-management for AI/ANs with T2D. Researchers will work with collaborators at the Oklahoma City Indian Clinic in Oklahoma City, OK, and an American Indian community advisory board (CAB) throughout the study to ensure the nutrition education and food security resources are designed to meet the needs of the community and clinic. With the guidance of the CAB, researchers will recruit adults with T2D to participate in a 3-month intervention. Participants will be randomized into one of 3 groups. Some people will have diabetes nutrition education and the food security resource, some will have only the diabetes nutrition education, and some will receive only the food security resource. Outcomes such as food security status and clinical diabetes health indicators will be measured at 5 timepoints. This intervention is significant to diabetes because AI/ANs experience diabetes health disparities and the combination of diabetes nutrition education plus an added food security resource could help decrease T2D complications and improve quality of life for AI/ANs.
Read the detailed description
Background: Healthy nutrition is key to T2D self-care and management. Culturally relevant nutrition education for American Indian and Alaska Natives (AI/Ans) is limited, contributing to diabetes health disparities, and disproportionate rates of food insecurity exacerbates these disparities.
Hypothesis: AI/ANs with T2D who receive both culturally relevant diabetes nutrition education and food security resources will have more improved outcomes (e.g., dietary intake, HbA1c) than AI/ANs with T2D who receive only diabetes nutrition education or a food security resource.
Supporting Rationale: Nutrition education improves T2D outcomes and reducing food insecurity can decrease diabetes health disparities.
Specific Aims: Aim #1: Engage an AI/AN community advisory board to support rigorous and equitable community based participatory research; Aim #2: Implement and evaluate a diabetes nutrition education and food security resource intervention in collaboration with the Oklahoma City Indian Clinic in Oklahoma City, OK.
Research Design: Three arm randomized controlled trial with: intervention group (diabetes nutrition education + food security resource); diabetes nutrition education group only; food security resource group only. Three month intervention with diabetes nutrition education and food security resource with 5 data collection timepoints: baseline, 1, 3, 6, 9 months. Outcomes include: HbA1c, blood pressure, dietary intake, diabetes distress, and food security.
Relevance to a cure, prevention and/or treatment of diabetes: Treatment of T2D among AI/ANs requires multi-level approaches to decrease health disparities related to social determinants of health such as lack of access to healthful foods. Providing both nutrition education and a food security resource could synergistically improve T2D self-management for AI/ANs
- Conditions
- Type 2 Diabetes
- Being tested
- Diabetes Nutrition Education Classes, Healthy Food Security Resource
- 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.
Diabetes Nutrition Education ClassesOther
Diabetes nutrition education offered by registered dietitian in group-based classes.
Healthy Food Security ResourceOther
Participants offered security resource which is a $30.00 Aldi (grocery store) gift card provided weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| What Can I Eat Diabetes Nutrition Education Classes Only | Experimental | Participants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 * 90 min in person classes weekly for a month, with 5th class at 3 months from baseline). Receives: Other: Diabetes Nutrition Education Classes |
| What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security Resource | Experimental | Participants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 * 90 min in person classes weekly for a month, with 5th class at 3 months from baseline). Additionally, patients will receive a $30.00 healthy food resource weekly for 12 weeks. Receives: Other: Diabetes Nutrition Education Classes; Other: Healthy Food Security Resource |
| Healthy Food Security Resource Only | Experimental | Patients will receive a $30.00 healthy food resource weekly for 12 weeks. Receives: Other: Healthy Food Security Resource |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Participant HbA1c will be collected by point of care fingerstick or electronic medical record
Measured: 0, 3, 6, 9 months
Secondary outcomes (8)
Blood pressure
Participant systolic and diastolic blood pressure measurements collected by arm cuff automated BP read or electronic medical record
Measured: 0, 3, 6, 9 months
Body weight
Body weight will be measured or collected via electronic medical record
Measured: 0, 3, 6, 9 months
Food insecurity
Self reported survey: Food insecurity measured by 18 item USDA food security module
Measured: 0, 3, 6, 9 months
Diabetes distress
Self reported survey: Participant diabetes distress measured by Problem Areas in Diabetes Scale (PAID-5)
Measured: 0, 3, 6, 9 months
Economic Quality of Life
Self reported survey: 10 item measure assessing the economic quality of life
Measured: 0, 3, 6, 9 months
Perceived Diabetes Self Management Scale (PDSMS)
Self reported survey: 8 item measure assessing perceived diabetes self management scale
Measured: 0, 3, 6, 9 months
What Can I Eat? Impact Survey
Self reported survey: 30 item measure assessing knowledge, self efficacy, and behavior from participating in "What Can I Eat?" diabetes nutrition education
Measured: 0, 3, 6, 9 months
Dietary intake - 24 hour recall
Dietitian proctored 24 hour dietary recall using ASA24
Measured: 0, 3 months (2 * 24 hour recalls at each timepoint = 4 * 24 hour recalls per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Sep 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arm RCT (nutrition education classes only, nutrition education classes + healthy food resource, healthy food resource only) - randomized at pt level, no stratification
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver, Washington State University, Oklahoma City Indian Clinic, Gretchen Swanson Center for Nutrition, University of North Carolina, Chapel Hill, University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Sarah Stotz, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077162
- Sponsor's protocol ID
- 4595
- Other IDs
- 5K01DK128023
- Acronym
- OKCICWCIE+
- Status last verified
- Nov 2025
- First submitted
- 5 Oct 2023
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Tribes are sovereign Indian Nations that have a unique government-to-government relationship with the Federal government. Many discussions, publications, and treatises have addressed how this relationship affects the ownership and sharing of data. The growing consensus on the part of Tribal communities is that the Indian Nations have an inherent right to at least an equal say in the fate of raw data. More recently, these same rights have been exercised by community organizations and agencies serving Native peoples. Decisions about sharing of data cannot be made without full discussion and agreement by the participating tribes or agencies. Each Tribe involved must approve all provisions laid down in such policies prior to the release of data to any outside investigator or entity. This includes seeking approval for abstracts and manuscripts to be presented and submitted to academic or scientific conferences and journals.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Nutrition Education (What Can I Eat? [WCIE]) and Healthy Food Resource for American Indians and Alaska Natives With T2D
- ClinicalTrials.gov ID
- NCT06077162
- Acronym / sponsor ID
- OKCICWCIE+ / 4595
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver, Washington State University, Oklahoma City Indian Clinic, Gretchen Swanson Center for Nutrition, University of North Carolina, Chapel Hill, University of California, Irvine
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 11 Oct 2023 (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.
Healthy nutrition habits are key to managing type 2 diabetes (T2D). However, American Indian and Alaska Natives (AI/ANs) often lack access to culturally relevant nutrition education and they disproportionately experience food insecurity. Food insecurity, defined as lack of consistent access to enough food for an active, healthy life, negatively impacts one's ability to engage in diabetes self-management and care. The purpose of this study is to evaluate if diabetes nutrition education and an added food security resource, such as farmers market vouchers for fruits and vegetables, can improve diabetes self-management for AI/ANs with T2D. Researchers will work with collaborators at the Oklahoma City Indian Clinic in Oklahoma City, OK, and an American Indian community advisory board (CAB) throughout the study to ensure the nutrition education and food security resources are designed to meet the needs of the community and clinic. With the guidance of the CAB, researchers will recruit adults with T2D to participate in a 3-month intervention. Participants will be randomized into one of 3 groups. Some people will have diabetes nutrition education and the food security resource, some will have only the diabetes nutrition education, and some will receive only the food security resource. Outcomes such as food security status and clinical diabetes health indicators will be measured at 5 timepoints. This intervention is significant to diabetes because AI/ANs experience diabetes health disparities and the combination of diabetes nutrition education plus an added food security resource could help decrease T2D complications and improve quality of life for AI/ANs.
Detailed description
Background: Healthy nutrition is key to T2D self-care and management. Culturally relevant nutrition education for American Indian and Alaska Natives (AI/Ans) is limited, contributing to diabetes health disparities, and disproportionate rates of food insecurity exacerbates these disparities.
Hypothesis: AI/ANs with T2D who receive both culturally relevant diabetes nutrition education and food security resources will have more improved outcomes (e.g., dietary intake, HbA1c) than AI/ANs with T2D who receive only diabetes nutrition education or a food security resource.
Supporting Rationale: Nutrition education improves T2D outcomes and reducing food insecurity can decrease diabetes health disparities.
Specific Aims: Aim #1: Engage an AI/AN community advisory board to support rigorous and equitable community based participatory research; Aim #2: Implement and evaluate a diabetes nutrition education and food security resource intervention in collaboration with the Oklahoma City Indian Clinic in Oklahoma City, OK.
Research Design: Three arm randomized controlled trial with: intervention group (diabetes nutrition education + food security resource); diabetes nutrition education group only; food security resource group only. Three month intervention with diabetes nutrition education and food security resource with 5 data collection timepoints: baseline, 1, 3, 6, 9 months. Outcomes include: HbA1c, blood pressure, dietary intake, diabetes distress, and food security.
Relevance to a cure, prevention and/or treatment of diabetes: Treatment of T2D among AI/ANs requires multi-level approaches to decrease health disparities related to social determinants of health such as lack of access to healthful foods. Providing both nutrition education and a food security resource could synergistically improve T2D self-management for AI/ANs
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 arm RCT (nutrition education classes only, nutrition education classes + healthy food resource, healthy food resource only) - randomized at pt level, no stratification
| Arm | Type | Receives |
|---|---|---|
| What Can I Eat Diabetes Nutrition Education Classes Only | Experimental | Other: Diabetes Nutrition Education ClassesParticipants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 * 90 min in person classes weekly for a month, with 5th class at 3 months from baseline). |
| What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security Resource | Experimental | Other: Diabetes Nutrition Education Classes, Other: Healthy Food Security ResourceParticipants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 * 90 min in person classes weekly for a month, with 5th class at 3 months from baseline). Additionally, patients will receive a $30.00 healthy food resource weekly for 12 weeks. |
| Healthy Food Security Resource Only | Experimental | Other: Healthy Food Security ResourcePatients will receive a $30.00 healthy food resource weekly for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dx type 2 diabetes; American Indian or Alaska Native; fluent in English
Key exclusion criteria (1 listed)
- Planned move within the study period
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 |
|---|---|---|
| Diabetes Nutrition Education ClassesDiabetes nutrition education offered by registered dietitian in group-based classes. | Other | What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security Resource, What Can I Eat Diabetes Nutrition Education Classes Only |
| Healthy Food Security ResourceParticipants offered security resource which is a $30.00 Aldi (grocery store) gift card provided weekly for 12 weeks. | Other | Healthy Food Security Resource Only, What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security Resource |
Primary outcome
Hemoglobin A1c
Time frame: 0, 3, 6, 9 months
Participant HbA1c will be collected by point of care fingerstick or electronic medical record
8 secondary outcomes
Blood pressure
Time frame: 0, 3, 6, 9 months
Body weight
Time frame: 0, 3, 6, 9 months
Food insecurity
Time frame: 0, 3, 6, 9 months
Diabetes distress
Time frame: 0, 3, 6, 9 months
Economic Quality of Life
Time frame: 0, 3, 6, 9 months
Perceived Diabetes Self Management Scale (PDSMS)
Time frame: 0, 3, 6, 9 months
What Can I Eat? Impact Survey
Time frame: 0, 3, 6, 9 months
Dietary intake - 24 hour recall
Time frame: 0, 3 months (2 * 24 hour recalls at each timepoint = 4 * 24 hour recalls per participant)
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 14 Nov 2025.
- Individual participant dataSharing planned: No. Tribes are sovereign Indian Nations that have a unique government-to-government relationship with the Federal government. Many discussions, publications, and treatises have addressed how this relationship affects the ownership and sharing of data. The growing consensus on the part of Tribal communities is that the Indian Nations have an inherent right to at least an equal say in the fate of raw data. More recently, these same rights have been exercised by community organizations and agencies serving Native peoples. Decisions about sharing of data cannot be made without full discussion and agreement by the participating tribes or agencies. Each Tribe involved must approve all provisions laid down in such policies prior to the release of data to any outside investigator or entity. This includes seeking approval for abstracts and manuscripts to be presented and submitted to academic or scientific conferences and journals.
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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. This study is not recruiting at the moment.
Sarah Stotz, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Nutrition Education Classes and Healthy Food Security Resource in people with Type 2 Diabetes, run by Colorado State University 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: 0, 3, 6, 9 months). 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 14 Nov 2025.