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Native American Diabetes Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05088616
Recruitment Status : Recruiting
First Posted : October 22, 2021
Last Update Posted : May 26, 2022
Sponsor:
Collaborators:
Project Angel Food
United American Indian Involvement, Inc.
Information provided by (Responsible Party):
Claradina Soto, University of Southern California

Brief Summary:

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

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).

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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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in A1c (from baseline to 90 days and 180 days) [ Time Frame: Baseline, 90 days, and 180 days ]

Secondary Outcome Measures :
  1. Change in blood pressure (from baseline to 90 days and 180 days) [ Time Frame: Baseline, 90 days, and 180 days ]
  2. Change in BMI (using weight and height) (from baseline to 90 days and 180 days) [ Time Frame: Baseline, 90 days, and 180 days ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Contacts
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Contact: Angelica Al Janabi, MPH 213-764-4550 nativedm@usc.edu

Locations
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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   
Sponsors and Collaborators
University of Southern California
Project Angel Food
United American Indian Involvement, Inc.
Investigators
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Principal Investigator: Claradina Soto, PhD, MPH University of Southern California
Publications:
Centers for Disease Control and Prevention. (2020). National diabetes statistics report. https://www.cdc.gov/diabetes/data/statistics-report/index.html
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
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

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claradina Soto, University of Southern California:
American Indian
Native American
Urban Indian
Alaska Native
Education
Wellness program
Meals
Nutrition
Classes
Virtual
Remote
Tribal
Indigenous
Native
Social interaction
Diabetes
Blood sugar
Buddy
Los Angeles
Urban
Additional relevant MeSH terms:
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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