Clinical Trial

Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D

Study acronym: OKCICWCIE+
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated November 14, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-10-05; most recent amendment 2025-11-13.
Status change: Recruiting → Active, Not Recruiting 2024-06-26
Trial Details
NCT Number NCT06077162
Lead Sponsor Colorado State University
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
Conditions Type 2 Diabetes
Enrollment 67 participants
Start Date 2023-09-01
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-14