Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Experimental | Participants receive diabetes nutrition education classes immediately. |
|
| Wait list intervention | Experimental | Participants wait listed (control) for 3 months and then receive the diabetes nutrition education classes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| American Indian and Alaska Native What Can I Eat? | Behavioral | 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 |
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kelly R Moore, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakeport Tribal Health Consortium | Lakeport | California | 95453 | United States | ||
| Cherokee Indian Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Cherokee |
| North Carolina |
| 28719 |
| United States |
| Indian Health Care Resource Center of Tulsa | Tulsa | Oklahoma | 74120 | United States |
| D004700 | Endocrine System Diseases |