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Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D

Diabetes Nutrition Education (What Can I Eat? [WCIE]) and Healthy Food Resource for American Indians and Alaska Natives With T2D

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06077162
Acronym
OKCICWCIE+
Enrollment
67
Registered
2023-10-11
Start date
2023-09-01
Completion date
2026-01-01
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief 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. 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

Interventions

OTHERDiabetes Nutrition Education Classes

Diabetes nutrition education offered by registered dietitian in group-based classes.

OTHERHealthy Food Security Resource

Participants offered security resource which is a $30.00 Aldi (grocery store) gift card provided weekly for 12 weeks.

Sponsors

American Diabetes Association
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Colorado, Denver
CollaboratorOTHER
Washington State University
CollaboratorOTHER
Oklahoma City Indian Clinic
CollaboratorUNKNOWN
Gretchen Swanson Center for Nutrition
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
University of California, Irvine
CollaboratorOTHER
Colorado State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Dx type 2 diabetes; American Indian or Alaska Native; fluent in English

Exclusion criteria

* Planned move within the study period

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin A1c0, 3, 6, 9 monthsParticipant HbA1c will be collected by point of care fingerstick or electronic medical record

Secondary

MeasureTime frameDescription
Body weight0, 3, 6, 9 monthsBody weight will be measured or collected via electronic medical record
Food insecurity0, 3, 6, 9 monthsSelf reported survey: Food insecurity measured by 18 item USDA food security module
Diabetes distress0, 3, 6, 9 monthsSelf reported survey: Participant diabetes distress measured by Problem Areas in Diabetes Scale (PAID-5)
Blood pressure0, 3, 6, 9 monthsParticipant systolic and diastolic blood pressure measurements collected by arm cuff automated BP read or electronic medical record
Perceived Diabetes Self Management Scale (PDSMS)0, 3, 6, 9 monthsSelf reported survey: 8 item measure assessing perceived diabetes self management scale
What Can I Eat? Impact Survey0, 3, 6, 9 monthsSelf reported survey: 30 item measure assessing knowledge, self efficacy, and behavior from participating in What Can I Eat? diabetes nutrition education
Dietary intake - 24 hour recall0, 3 months (2 * 24 hour recalls at each timepoint = 4 * 24 hour recalls per participant)Dietitian proctored 24 hour dietary recall using ASA24
Economic Quality of Life0, 3, 6, 9 monthsSelf reported survey: 10 item measure assessing the economic quality of life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026