Native American Diabetes Project

December 14, 2023 updated by: Claradina Soto, University of Southern California

Community Partnered Medical Nutrition Intervention for Native Americans Living With Diabetes

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 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

Enrollment (Estimated)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90032
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Virtual Diabetes Wellness Classes and Medically Tailored Meals
Four weeks of virtual diabetes wellness classes and 12 weeks of medically tailored meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in A1c (from baseline to 90 days and 180 days)
Time Frame: Baseline, 90 days, and 180 days
Baseline, 90 days, and 180 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in blood pressure (from baseline to 90 days and 180 days)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 90 days, and 180 days
Baseline, 90 days, and 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

Project Angel Food
United American Indian Involvement, Inc.

Investigators

  • Principal Investigator: Claradina Soto, PhD, MPH, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP-20-01441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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