Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D

Study Overview
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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

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Diabetes Nutrition Education Classes
* Other: Healthy Food Security Resource


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 arm RCT (nutrition education classes only, nutrition education classes + healthy food resource, healthy food resource only) - randomized at pt level, no stratification
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: What Can I Eat Diabetes Nutrition Education Classes Only<br>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<br>* Diabetes nutrition education offered by registered dietitian in group-based classes.<br>|
| Experimental: What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security Resource<br>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<br>* Diabetes nutrition education offered by registered dietitian in group-based classes.<br>Other: Healthy Food Security Resource<br>* Participants offered security resource which is a $30.00 Aldi (grocery store) gift card provided weekly for 12 weeks.<br>|
| Experimental: Healthy Food Security Resource Only<br>Patients will receive a $30.00 healthy food resource weekly for 12 weeks. | Other: Healthy Food Security Resource<br>* Participants offered security resource which is a $30.00 Aldi (grocery store) gift card provided weekly for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Participant HbA1c will be collected by point of care fingerstick or electronic medical record | 0, 3, 6, 9 months | 

Secondary Outcome Measures

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