Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D (OKCICWCIE+)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Diabetes Nutrition Education Classes; Other: Healthy Food Security Resource

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73127
      • Oklahoma City Indian Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Planned move within the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: What Can I Eat Diabetes Nutrition Education Classes Only; 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).	Other: Diabetes Nutrition Education Classes; Diabetes nutrition education offered by registered dietitian in group-based classes.
Experimental: What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security Resource; 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.	Other: Diabetes Nutrition Education Classes; Diabetes nutrition education offered by registered dietitian in group-based classes.; Other: Healthy Food Security Resource; Participants offered security resource which is a $30.00 Aldi (grocery store) gift card provided weekly for 12 weeks.
Experimental: Healthy Food Security Resource Only; Patients will receive a $30.00 healthy food resource weekly for 12 weeks.	Other: Healthy Food Security Resource; Participants offered security resource which is a $30.00 Aldi (grocery store) gift card provided weekly for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	Participant HbA1c will be collected by point of care fingerstick or electronic medical record	0, 3, 6, 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Participant systolic and diastolic blood pressure measurements collected by arm cuff automated BP read or electronic medical record	0, 3, 6, 9 months
Body weight	Body weight will be measured or collected via electronic medical record	0, 3, 6, 9 months
Food insecurity	Self reported survey: Food insecurity measured by 18 item USDA food security module	0, 3, 6, 9 months
Diabetes distress	Self reported survey: Participant diabetes distress measured by Problem Areas in Diabetes Scale (PAID-5)	0, 3, 6, 9 months
Economic Quality of Life	Self reported survey: 10 item measure assessing the economic quality of life	0, 3, 6, 9 months
Perceived Diabetes Self Management Scale (PDSMS)	Self reported survey: 8 item measure assessing perceived diabetes self management scale	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	0, 3, 6, 9 months
Dietary intake - 24 hour recall	Dietitian proctored 24 hour dietary recall using ASA24	0, 3 months (2 * 24 hour recalls at each timepoint = 4 * 24 hour recalls per participant)

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: University of Colorado, Denver; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Washington State University; University of North Carolina, Chapel Hill; University of California, Irvine; American Diabetes Association; Gretchen Swanson Center for Nutrition; Oklahoma City Indian Clinic
• Investigators: Principal Investigator: Sarah Stotz, PhD, Colorado State University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 4595; 5K01DK128023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No