Native American Diabetes Project (NADP)

University of Southern California

Status: Terminated

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus; Diabetes Type 1; Diabetes Mellitus, Type 2; Diabete Type 2

Treatments: Behavioral: Virtual Diabetes Wellness Classes and Medically Tailored Meals

Study type: Interventional

Funder types: Other

Identifiers

NCT05088616

UP-20-01441

Details and patient eligibility

About

This research study is for American Indian and Alaska Native (AIAN) people with diabetes in Los Angeles County, California. Participants (people who join the study) are signed up for a program that includes healthy meals, online diabetes classes, and social support.

This study aims to answer the following question:

Can this program (the meals, classes, and social support) have health and well-being benefits for participants, like lower blood sugar levels and less social isolation?

Participants are asked to fill out surveys and go to three clinic visits. Participants do not have to pay for the clinic visits or any other parts of the study.

Full description

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 was originally to reach up to 312 Native Americans with diabetes (later reduced, aiming for 150) 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. Each participant will be part of a 180-day cohort, during which participants will complete surveys and attend three clinic visits.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Reside in Los Angeles County,
2. 18 years and older,
3. Diabetic
4. Identify as American Indian or Alaska Native,
5. Have freezer space for 14 meals (about the size of two shoe boxes),
6. Ability to attend virtual classes via Zoom,
7. Ability to complete electronic surveys distributed by email,
8. Ability to commit to attending at least five of the six initial classes and meetings,
9. Ability to commit to making personal arrangements to attend three study clinic visits during weekday, daytime hours, and
10. Ability to consent to study activities, attend classes, and complete surveys all in English.

Exclusion criteria

1. Pregnancy,
2. Food allergies,
3. Serious non-allergic reactions to foods, and
4. Unable or unwilling to eat study meals (considering the limited accommodations available).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Virtual Diabetes Wellness Classes and Medically Tailored Meals

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Diabetes Wellness Classes and Medically Tailored Meals