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Active, Not Recruiting

NCT Number: NCT06077162

Diabetes Nutrition Education and Healthy Food Resource for AIANs 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma City Indian Clinic

Oklahoma City, Oklahoma, 73127, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Planned move within the study period

Treatment and study plan

Diabetes Nutrition Education Classes

Other

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

Healthy Food Security Resource

Other

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

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 0, 3, 6, 9 months

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

Secondary outcomes

  1. Blood pressure

    Time frame: 0, 3, 6, 9 months

    Participant systolic and diastolic blood pressure measurements collected by arm cuff automated BP read or electronic medical record

  2. Body weight

    Time frame: 0, 3, 6, 9 months

    Body weight will be measured or collected via electronic medical record

  3. Food insecurity

    Time frame: 0, 3, 6, 9 months

    Self reported survey: Food insecurity measured by 18 item USDA food security module

  4. Diabetes distress

    Time frame: 0, 3, 6, 9 months

    Self reported survey: Participant diabetes distress measured by Problem Areas in Diabetes Scale (PAID-5)

  5. Economic Quality of Life

    Time frame: 0, 3, 6, 9 months

    Self reported survey: 10 item measure assessing the economic quality of life

  6. Perceived Diabetes Self Management Scale (PDSMS)

    Time frame: 0, 3, 6, 9 months

    Self reported survey: 8 item measure assessing perceived diabetes self management scale

  7. What Can I Eat? Impact Survey

    Time frame: 0, 3, 6, 9 months

    Self reported survey: 30 item measure assessing knowledge, self efficacy, and behavior from participating in "What Can I Eat?" diabetes nutrition education

  8. Dietary intake - 24 hour recall

    Time frame: 0, 3 months (2 * 24 hour recalls at each timepoint = 4 * 24 hour recalls per participant)

    Dietitian proctored 24 hour dietary recall using ASA24

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

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

Registry information

Official study title

Diabetes Nutrition Education (What Can I Eat? [WCIE]) and Healthy Food Resource for American Indians and Alaska Natives With T2D

Acronym: OKCICWCIE+

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2023
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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