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Native American Diabetes Project

Community Partnered Medical Nutrition Intervention for Native Americans Living with Diabetes

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05088616
Acronym
NADP
Enrollment
53
Registered
2021-10-22
Start date
2021-10-28
Completion date
2023-10-31
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

American Indian, Alaska Native, Native American, Education, Wellness program, Meals, Nutrition, Classes, Tribal, Indigenous, Native, Social interaction, Diabetes, Blood sugar, Buddy, Urban Indian, Urban, online classes, virtual classes, Los Angeles, AIAN, Los Angeles County, A1c, blood, clinic, diabetes education, public health, social, social isolation, isolation, behavior, behavioral, culture, cultural connectedness, connection, well-being, population, population health, adults, urban population, race, chronic disease, food, healthy food, patient education, North America, California, Southern California, Pacific States, United States, ethnic and racial minorities, Indians, North American, Indigenous peoples, endocrine system diseases, diabetes mellitus, sugar, diet, meal delivery, early termination of clinical trials, surveys, Zoom, labs, blood test

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.

Interventions

BEHAVIORALVirtual Diabetes Wellness Classes and Medically Tailored Meals

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

Sponsors

Project Angel Food
CollaboratorUNKNOWN
United American Indian Involvement, Inc.
CollaboratorUNKNOWN
University of Southern California
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

All participants receive the same intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Change in A1c (from baseline to 90 days and 180 days)Baseline, 90 days, and 180 days

Secondary

MeasureTime frame
Change in blood pressure (from baseline to 90 days and 180 days)Baseline, 90 days, and 180 days
Change in BMI (using weight and height) (from baseline to 90 days and 180 days)Baseline, 90 days, and 180 days
Change in social isolation (using loneliness measure survey questions) (from baseline to 90 days and 180 days)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)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)Baseline, 90 days, and 180 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026