Diabetes Nutrition Education for American Indian and Alaska Native Communities

Study Overview
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Brief Summary
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This study involves pilot testing a newly developed diabetes nutrition education program for American Indian and Alaska Native adults with T2D. The first phase of this study (COMIRB Protocol 18-006) included a qualitative needs assessment to inform the development of this program. The Study Aims include: piloting the newly adapted program at 6 AI/AN collaborating sites to gain feedback on satisfaction, likability, usability and clinical outcomes such as HgA1C (measure of blood sugar control), blood pressure, and body mass index (BMI).

Detailed Description
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This study involves pilot testing a newly developed diabetes nutrition education program for American Indian and Alaska Native adults with T2D. The first phase of this study (COMIRB Protocol 18-006) included a qualitative needs assessment to inform the development of this program. The second phase involves pilot testing the study at 6 collaborating AI/AN sites across the US. The Study Aims include: piloting the newly adapted program at 6 AI/AN collaborating sites to gain feedback on satisfaction, likability, usability and clinical outcomes such as HgA1C (measure of blood sugar control), blood pressure, and body mass index (BMI).

Official Title
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Test of a Culturally Tailored Diabetes Nutrition Education Program for Tribal and Urban American Indian and Alaska Native (AIAN) Communities

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: American Indian and Alaska Native What Can I Eat?


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AI/AN status (self-reported) age > 18 years fluent in English a current diagnosis of T2DM. Exclusion Criteria: a major medical issue that may interfere with participation (e.g., prior cardio- or cerebrovascular disease including a recent myocardial infarction or major stroke; cancer not in remission; dialysis; active alcohol and/or substance abuse.) a planned move from the area within the 3 to 6 month data collection time period that would not allow completion of all the study visits

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention<br>Participants receive diabetes nutrition education classes immediately. | Behavioral: American Indian and Alaska Native What Can I Eat?<br>* Participants will engage in 5  90 minute diabetes nutrition education classes. They will learn about healthy eating for type 2 diabetes management. Classes include didactic lesson, hands on learning activity, sharing session, mindful nutrition practice, and physical activity<br>|
| Experimental: Wait list intervention<br>Participants wait listed (control) for 3 months and then receive the diabetes nutrition education classes. | Behavioral: American Indian and Alaska Native What Can I Eat?<br>* Participants will engage in 5  90 minute diabetes nutrition education classes. They will learn about healthy eating for type 2 diabetes management. Classes include didactic lesson, hands on learning activity, sharing session, mindful nutrition practice, and physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate diabetes nutrition education program impact on HgA1C | Participants will have 2 A1C checks for Immediate intervention and 3 for wait list control. Immediate will have A1C tested at baseline and after the 5th class (at 3 months from baseline). Wait list will have A1C checked baseline, immediately before class #1 (3 months after baseline) and after class #5 (6 months after baseline). A1C will be checked per standard of care at the clinical site | 3 months for immediate intervention group 6 months for wait list control group | 
| Evaluate diabetes nutrition education program impact on blood pressure | Participants will have 3 BP checks for Immediate intervention and 5 for wait list control. Immediate will have BP tested at baseline, after the 4th class, and after the 5th class (at 3 months from baseline). Wait list will have BP checked baseline, immediately before class #1 (3 months after baseline), 1 month after baseline, after class #4, and after class #5 (6 months after baseline). Blood pressure will be checked per standard of care at the clinical site. | 3 months for immediate intervention group 6 months for wait list control group | 
| Evaluate diabetes nutrition education program impact on weight | Participants will have 3 weight checks for Immediate intervention and 5 for wait list control. Immediate will have weight tested at baseline, after the 4th class, and after the 5th class (at 3 months from baseline). Wait list will have weight checked baseline, at one month of wait list, immediately before class #1 (3 months after baseline), after class #4, and after class #5 (6 months after baseline). Weight will be checked per standard of care at the clinical site. | 3 months for immediate intervention group 6 months for wait list control group | 
| Evaluate diabetes nutrition education program impact on eating behavior | Participants will take a self-reported survey measuring their dietary habits using a food frequency table at several timepoints. Immediate intervention participants will take the survey 3 times (baseline, after class 4, after class 5). Wait list control participants will take the survey 5 times (baseline, at 1 month after baseline wait list, immediately before class #1, after class #4, after class #5) | 3 months for immediate intervention group 6 months for wait list control group | 
| Evaluate diabetes nutrition education program impact on nutrition knowledge | Participants will take a self-reported survey measuring their nutrition knowledge using a food frequency table at several timepoints. Immediate intervention participants will take the survey 3 times (baseline, after class 4, after class 5). Wait list control participants will take the survey 5 times (baseline, at 1 month after baseline wait list, immediately before class #1, after class #4, after class #5) | 3 months for immediate intervention group 6 months for wait list control group | 
| Evaluate diabetes nutrition education program impact on self efficacy for healthful eating | Participants will take a self-reported survey measuring their self efficacy for healthy eating using a food frequency table at several timepoints. Immediate intervention participants will take the survey 3 times (baseline, after class 4, after class 5). Wait list control participants will take the survey 5 times (baseline, at 1 month after baseline wait list, immediately before class #1, after class #4, after class #5) | 3 months for immediate intervention group 6 months for wait list control group |