Native American Diabetes Project

NCT ID: NCT05088616

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-28
• Study Completion Date: 2023-10-31

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Diabetes Wellness Classes and Medically Tailored Meals

Intervention Type: BEHAVIORAL

Four weeks of virtual diabetes wellness classes and 12 weeks of medically tailored meals.

Interventions

Virtual Diabetes Wellness Classes and Medically Tailored Meals

Four weeks of virtual diabetes wellness classes and 12 weeks of medically tailored meals.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Project Angel Food

UNKNOWN

Sponsor Role: collaborator

United American Indian Involvement, Inc.

UNKNOWN

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Claradina Soto

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claradina Soto, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

References

Centers for Disease Control and Prevention. (2020). National diabetes statistics report. https://www.cdc.gov/diabetes/data/statistics-report/index.html

Reference Type: BACKGROUND

Garcia AN, Castro MC, Sanchez JP. Social and Structural Determinants of Urban American Indian and Alaska Native Health: A Case Study in Los Angeles. MedEdPORTAL. 2019 May 15;15:10825. doi: 10.15766/mep_2374-8265.10825.

Reference Type: BACKGROUND

PMID: 31161137 (View on PubMed)

Office of Disease Prevention and Health Promotion, n.d. Diabetes. Healthy people 2020. U.S. Department of Health and Human Services. https://www.healthypeople.gov/2020/data-search/Search-the-Data?topic-area=3514

Reference Type: BACKGROUND

UCLA Center for Health Policy Research. (2017). American Indian and Alaska Native diabetes: critical information for researchers and policy-makers [Fact sheet]. https://healthpolicy.ucla.edu/publications/Documents/PDF/AIANDiabetesmay2012.pdf

Reference Type: BACKGROUND

Other Identifiers

UP-20-01441

Identifier Type: -

Identifier Source: org_study_id