Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077162
• Other study ID #: OKCIC WCIE+
• Secondary ID: 5K01DK128023
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: November 15, 2025

Study information

• Verified date: October 2023
• Source: Colorado State University
• Contact: Sarah A Stotz, PhD
• Phone: 858-232-3545
• Email: sarah.stotz[@]colostate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 15, 2025
• Est. primary completion date: November 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Planned move within the study period

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Other:
• Diabetes Nutrition Education Classes
Diabetes nutrition education offered by registered dietitian in group-based classes.
• Healthy Food Security Resource
Participants offered security resource which is a $30.00 Aldi (grocery store) gift card provided weekly for 12 weeks.

Locations

Country	Name	City	State
United States	Oklahoma City Indian Clinic	Oklahoma City	Oklahoma

Sponsors (9)

Lead Sponsor	Collaborator
Colorado State University	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Participant HbA1c will be collected by point of care fingerstick or electronic medical record	0, 3, 6, 9 months
Secondary	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
Secondary	Body weight	Body weight will be measured or collected via electronic medical record	0, 3, 6, 9 months
Secondary	Food insecurity	Self reported survey: Food insecurity measured by 18 item USDA food security module	0, 3, 6, 9 months
Secondary	Diabetes distress	Self reported survey: Participant diabetes distress measured by Problem Areas in Diabetes Scale (PAID-5)	0, 3, 6, 9 months
Secondary	Economic Quality of Life	Self reported survey: 10 item measure assessing the economic quality of life	0, 3, 6, 9 months
Secondary	Perceived Diabetes Self Management Scale (PDSMS)	Self reported survey: 8 item measure assessing perceived diabetes self management scale	0, 3, 6, 9 months
Secondary	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
Secondary	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)