Native American Diabetes Project
Primary Purpose
Diabetes, Diabete Type 2, Diabetes Mellitus, Type 1
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Diabetes Wellness Classes and Medically Tailored Meals
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes focused on measuring American Indian, Alaska Native, Native American, Education, Wellness program, Meals, Nutrition, Classes, Virtual, Remote, Tribal, Indigenous, Native, Social interaction, Diabetes, Blood sugar, Buddy, Los Angeles, Urban Indian, Urban
Eligibility Criteria
Inclusion Criteria:
- Reside in Los Angeles County,
- 18 years and older,
- Diabetic
- Identify as American Indian or Alaska Native,
- Have freezer space for 14 meals (about the size of two shoe boxes),
- Ability to attend virtual classes via Zoom,
- Ability to complete electronic surveys distributed by email,
- Ability to commit to attending at least five of the six initial classes and meetings,
- Ability to commit to making personal arrangements to attend three study clinic visits during weekday, daytime hours, and
- Ability to consent to study activities, attend classes, and complete surveys all in English.
Exclusion Criteria:
- Pregnancy,
- Food allergies,
- Serious non-allergic reactions to foods, and
- Unable or unwilling to eat study meals (considering the limited accommodations available).
Sites / Locations
- University of Southern CaliforniaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual Diabetes Wellness Classes and Medically Tailored Meals
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in A1c (from baseline to 90 days and 180 days)
Secondary Outcome Measures
Change in blood pressure (from baseline to 90 days and 180 days)
Change in BMI (using weight and height) (from baseline to 90 days and 180 days)
Change in social isolation (using loneliness measure survey questions) (from baseline to 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)
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)
Full Information
NCT ID
NCT05088616
First Posted
October 8, 2021
Last Updated
May 22, 2022
Sponsor
University of Southern California
Collaborators
Project Angel Food, United American Indian Involvement, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05088616
Brief Title
Native American Diabetes Project
Official Title
Community Partnered Medical Nutrition Intervention for Native Americans Living With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
October 28, 2023 (Anticipated)
Study Completion Date
October 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Project Angel Food, United American Indian Involvement, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabete Type 2, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Type 1, Diabetes Mellitus
Keywords
American Indian, Alaska Native, Native American, Education, Wellness program, Meals, Nutrition, Classes, Virtual, Remote, Tribal, Indigenous, Native, Social interaction, Diabetes, Blood sugar, Buddy, Los Angeles, Urban Indian, Urban
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
312 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Diabetes Wellness Classes and Medically Tailored Meals
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Diabetes Wellness Classes and Medically Tailored Meals
Intervention Description
Four weeks of virtual diabetes wellness classes and 12 weeks of medically tailored meals.
Primary Outcome Measure Information:
Title
Change in A1c (from baseline to 90 days and 180 days)
Time Frame
Baseline, 90 days, and 180 days
Secondary Outcome Measure Information:
Title
Change in blood pressure (from baseline to 90 days and 180 days)
Time Frame
Baseline, 90 days, and 180 days
Title
Change in BMI (using weight and height) (from baseline to 90 days and 180 days)
Time Frame
Baseline, 90 days, and 180 days
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Reside in Los Angeles County,
18 years and older,
Diabetic
Identify as American Indian or Alaska Native,
Have freezer space for 14 meals (about the size of two shoe boxes),
Ability to attend virtual classes via Zoom,
Ability to complete electronic surveys distributed by email,
Ability to commit to attending at least five of the six initial classes and meetings,
Ability to commit to making personal arrangements to attend three study clinic visits during weekday, daytime hours, and
Ability to consent to study activities, attend classes, and complete surveys all in English.
Exclusion Criteria:
Pregnancy,
Food allergies,
Serious non-allergic reactions to foods, and
Unable or unwilling to eat study meals (considering the limited accommodations available).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angelica Al Janabi, MPH
Phone
213-764-4550
Email
nativedm@usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claradina Soto, PhD, MPH
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelica Al Janabi, MPH
Phone
213-764-4550
Email
nativedm@usc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Centers for Disease Control and Prevention. (2020). National diabetes statistics report. https://www.cdc.gov/diabetes/data/statistics-report/index.html
Results Reference
background
PubMed Identifier
31161137
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
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Native American Diabetes Project
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