Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D

NCT06077162 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-11-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • American Diabetes Association

    collaborator OTHER
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • University of Colorado, Denver

    collaborator OTHER
  • Washington State University

    collaborator OTHER
  • Oklahoma City Indian Clinic

    collaborator UNKNOWN
  • Gretchen Swanson Center for Nutrition

    collaborator OTHER
  • University of North Carolina, Chapel Hill

    collaborator OTHER
  • University of California, Irvine

    collaborator OTHER
  • Colorado State University

    lead OTHER

Principal Investigators

  • Sarah Stotz, PhD · Colorado State University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2026-01-01
Completion
2026-01-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06077162 on ClinicalTrials.gov