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Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D

NCT ID: NCT06077162

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-01-01

Brief Summary

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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

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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

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 arm RCT (nutrition education classes only, nutrition education classes + healthy food resource, healthy food resource only) - randomized at pt level, no stratification
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Diabetes Nutrition Education Classes

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Diabetes Nutrition Education Classes

Intervention Type OTHER

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

Healthy Food Security Resource

Intervention Type 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

Patients will receive a $30.00 healthy food resource weekly for 12 weeks.

Group Type EXPERIMENTAL

Healthy Food Security Resource

Intervention Type OTHER

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

Interventions

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Diabetes Nutrition Education Classes

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

Intervention Type OTHER

Healthy Food Security Resource

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Planned move within the study period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Diabetes Association

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

Washington State University

OTHER

Sponsor Role collaborator

Oklahoma City Indian Clinic

UNKNOWN

Sponsor Role collaborator

Gretchen Swanson Center for Nutrition

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role collaborator

Colorado State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Stotz, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

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Oklahoma City Indian Clinic

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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5K01DK128023

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4595

Identifier Type: -

Identifier Source: org_study_id