Native American Diabetes Project
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| ClinicalTrials.gov Identifier: NCT05088616 |
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Recruitment Status :
Recruiting
First Posted : October 22, 2021
Last Update Posted : May 26, 2022
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Diabetes in the American Indian and Alaska Native (AIAN) population is a public health crisis that is best addressed using a holistic approach.
Given the disproportionate rates of diabetes and diabetes-related outcomes among AIANs, this is the perfect opportunity to provide a culturally tailored health promotion intervention among the largest urban AIAN population in the U.S.; approximately 171,163 AIANs reside in Los Angeles County. It is imperative to develop culturally tailored interventions with a community-based participatory research approach. Particularly given a legacy of historical mistrust, development of trusted and mutually beneficial partnerships is imperative.
The goal of this pilot study is to reach up to 312 Native Americans with diabetes to participate in an intervention to lower blood sugar and feelings of social isolation. The intervention will include 12 weeks of diabetes-friendly, medically tailored meals, and four weeks of virtual diabetes wellness classes. Participants will also attend an initial meet-and-greet before the classes start, a check-in meeting after the classes end, and up to three additional follow-up meetings. There may also be an in-person meeting near the end of the study. Partners for these activities include Project Angel Food and United American Indian Involvement (UAII). Each of the four virtual classes will be held for 90-minutes through the Zoom platform. Each participant will be part of a 180-day cohort. Participants will complete surveys and attend three clinic visits as part of the study.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Diabete Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Type 1 Diabetes Mellitus | Behavioral: Virtual Diabetes Wellness Classes and Medically Tailored Meals | Not Applicable |
Diabetes in the American Indian and Alaska Native (AIAN) population is a public health crisis. AIAN have the highest diabetes prevalence rates when compared to other racial and ethnic populations in the United States. According to the Centers for Disease Control and Prevention, 14.7% of AIAN adults compared to 7.5% of non-Hispanic Whites have been diagnosed with diabetes. In California (CA), those who self-identify as having CA Tribal heritage are twice as likely than individuals from tribes outside of CA to be diagnosed with diabetes (31% versus 16%). Significant disparities also exist in diabetes-related outcomes. Compared to the general population, AIANs are 2.3 times more likely to die from diabetes, and the incidence of diabetes-related kidney failure among AIANs is 2.0 times higher. Cardiovascular disease among AIANs with diabetes may be 3-8 times higher than those AIAN without diabetes.
The diabetes crisis among AIAN is best addressed using a holistic approach. Aside from addressing the impact of diabetes on several physical health outcomes, best practices also include addressing the impact of trauma and mental and emotional health, providing robust patient education, and addressing structural barriers such as food insecurity, lack of access to healthy food, living in poverty, limited social support, and lack of access to health care, especially that which is culturally responsive.
Given the disproportionate rates of diabetes and diabetes-related outcomes among AIANs, this is the perfect opportunity to provide a culturally tailored health promotion intervention among the largest urban AIAN population in the U.S.; approximately 171,163 AIANs reside in Los Angeles County.
The goal of this pilot study is to reach up to 312 Native Americans with diabetes to participate in an intervention to lower blood sugar and feelings of social isolation. The intervention will include 12 weeks of diabetes-friendly, medically tailored meals, and four weeks of virtual diabetes wellness classes. The meals are pre-made and frozen by Project Angel Food, a meal preparation and delivery company located in Los Angeles, CA. Fourteen meals (7 days x 2 meals per day: lunch/dinner) will be provided weekly for 12 weeks. Participants will also attend an initial meet-and-greet before the classes start and a final check-in meeting after the classes end. Up to three additional follow-up meetings may be held after the final check-in. There may also be an in-person meeting near the end of the study. Each of the four virtual class sessions will be held for 90-minutes through the Zoom platform. Participants will begin the 4-week curriculum approximately the same week they start receiving the medically tailored meals. After the four weeks of classes are completed, participants will continue to receive meals for the remaining (approximate) 8 weeks. Each participant will be part of a 180-day cohort, during which participants will complete surveys and attend three clinic visits (where their blood pressure, weight, height, and A1c levels--via finger stick--will be measured).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 312 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Community Partnered Medical Nutrition Intervention for Native Americans Living With Diabetes |
| Actual Study Start Date : | October 28, 2021 |
| Estimated Primary Completion Date : | October 28, 2023 |
| Estimated Study Completion Date : | October 28, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Virtual Diabetes Wellness Classes and Medically Tailored Meals
All participants will receive the same intervention: four weeks of virtual diabetes wellness classes and 12 weeks of medically tailored meals. Additionally, participants will be paired with one to two "buddies" to provide support to each other.
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Behavioral: Virtual Diabetes Wellness Classes and Medically Tailored Meals
Four weeks of virtual diabetes wellness classes and 12 weeks of medically tailored meals. |
- Change in A1c (from baseline to 90 days and 180 days) [ Time Frame: Baseline, 90 days, and 180 days ]
- Change in blood pressure (from baseline to 90 days and 180 days) [ Time Frame: Baseline, 90 days, and 180 days ]
- Change in BMI (using weight and height) (from baseline to 90 days and 180 days) [ Time Frame: Baseline, 90 days, and 180 days ]
- Change in social isolation (using loneliness measure survey questions) (from baseline to 90 days and 180 days) [ Time Frame: Baseline, 90 days, and 180 days ]
- Change in level of diabetes distress (using diabetes distress scale survey responses) (from baseline to 90 days and 180 days) [ Time Frame: Baseline, 90 days, and 180 days ]
- Change in identity and level of cultural connectedness (using part of Multigroup Ethnic Identity Measure survey questions) (from baseline to 90 days and 180 days) [ Time Frame: Baseline, 90 days, and 180 days ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Reside in Los Angeles County,
- 18 years and older,
- Diabetic
- Identify as American Indian or Alaska Native,
- Have freezer space for 14 meals (about the size of two shoe boxes),
- Ability to attend virtual classes via Zoom,
- Ability to complete electronic surveys distributed by email,
- Ability to commit to attending at least five of the six initial classes and meetings,
- Ability to commit to making personal arrangements to attend three study clinic visits during weekday, daytime hours, and
- Ability to consent to study activities, attend classes, and complete surveys all in English.
Exclusion Criteria:
- Pregnancy,
- Food allergies,
- Serious non-allergic reactions to foods, and
- Unable or unwilling to eat study meals (considering the limited accommodations available).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05088616
| Contact: Angelica Al Janabi, MPH | 213-764-4550 | nativedm@usc.edu |
| United States, California | |
| University of Southern California | Recruiting |
| Los Angeles, California, United States, 90032 | |
| Contact: Angelica Al Janabi, MPH 213-764-4550 nativedm@usc.edu | |
| Principal Investigator: | Claradina Soto, PhD, MPH | University of Southern California |
| Responsible Party: | Claradina Soto, Assistant Professor, University of Southern California |
| ClinicalTrials.gov Identifier: | NCT05088616 |
| Other Study ID Numbers: |
UP-20-01441 |
| First Posted: | October 22, 2021 Key Record Dates |
| Last Update Posted: | May 26, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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American Indian Alaska Native Native American Education Wellness program Meals Nutrition Classes Virtual Remote |
Tribal Indigenous Native Social interaction Diabetes Blood sugar Buddy Los Angeles Urban Indian Urban |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |