Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D

NCT06077162 | Active Not Recruiting

• 2 other identifiers: 45955K01DK128023
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Participant HbA1c will be collected by point of care fingerstick or electronic medical record

  0, 3, 6, 9 months

Secondary Outcomes (8)

• Blood pressure

  0, 3, 6, 9 months

• Body weight

  0, 3, 6, 9 months

• Food insecurity

  0, 3, 6, 9 months

• Diabetes distress

  0, 3, 6, 9 months

• Economic Quality of Life

  0, 3, 6, 9 months

Study Arms (3)

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).

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.

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.

Other: Healthy Food Security Resource

Interventions

Diabetes Nutrition Education Classes OTHER

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

What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security Resource; What Can I Eat Diabetes Nutrition Education Classes Only

Healthy Food Security Resource OTHER

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

Healthy Food Security Resource Only; What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security Resource

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Planned move within the study period

Sponsors & Collaborators

• Colorado State University: lead
• American Diabetes Association: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Colorado, Denver: collaborator
• Washington State University: collaborator
• Oklahoma City Indian Clinic: collaborator
• Gretchen Swanson Center for Nutrition: collaborator
• University of North Carolina, Chapel Hill: collaborator
• University of California, Irvine: collaborator

Study Sites (1)

Oklahoma City Indian Clinic

Oklahoma City, Oklahoma, 73127, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sarah Stotz, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 arm RCT (nutrition education classes only, nutrition education classes + healthy food resource, healthy food resource only) - randomized at pt level, no stratification

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)