Native American Diabetes Project

• ClinicalTrials.gov Identifier: NCT05088616
• Recruitment Status: Recruiting
• First Posted: October 22, 2021
• Last Update Posted: January 28, 2022
• Sponsor: University of Southern California
• Collaborators: Project Angel Food; United American Indian Involvement, Inc.
• Information provided by (Responsible Party): Claradina Soto, University of Southern California

Tracking Information

• First Submitted Date: October 8, 2021
• First Posted Date: October 22, 2021
• Last Update Posted Date: January 28, 2022
• Actual Study Start Date: October 28, 2021
• Estimated Primary Completion Date: October 28, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 20, 2021): Change in A1c (from baseline to 90 days and 180 days) [ Time Frame: Baseline, 90 days, and 180 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 20, 2021)

• Change in blood pressure (from baseline to 90 days and 180 days) [ Time Frame: 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 ]
• 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 ]
• 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 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Native American Diabetes Project
• Official Title: Community Partnered Medical Nutrition Intervention for Native Americans Living With Diabetes

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 final check-in meeting after the classes end, and up to three additional follow-up meetings. 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.

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. The virtual diabetes wellness classes use a culturally tailored four-week curriculum. 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. The classes will be implemented by United American Indian Involvement (UAII) staff. 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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

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

Intervention

Behavioral: Virtual Diabetes Wellness Classes and Medically Tailored Meals

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

Study Arms

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, although participants can opt out of having a "buddy" and still participate in the rest of the study.

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

Publications *

• Centers for Disease Control and Prevention. (2020). National diabetes statistics report. https://www.cdc.gov/diabetes/data/statistics-report/index.html
• Garcia AN, Castro MC, Sánchez 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.
• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 20, 2021): 312
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 28, 2023
• Estimated Primary Completion Date: October 28, 2023 (Final data collection date for primary outcome measure)

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 through the internet or calling in by phone,
7. Ability to complete electronic surveys distributed by email or text, and
8. Ability to commit to attending at least five of the six initial classes and meetings, and
9. Ability to commit to making personal arrangements to attend three study clinic visits during weekday, daytime hours.

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05088616
• Other Study ID Numbers: UP-20-01441
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Claradina Soto, University of Southern California
• 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

• PRS Account: University of Southern California
• Verification Date: January 2022