Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : January 28, 2022
Sponsor:
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  ICMJE October 8, 2021
First Posted Date  ICMJE October 22, 2021
Last Update Posted Date January 28, 2022
Actual Study Start Date  ICMJE October 28, 2021
Estimated Primary Completion Date October 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Native American Diabetes Project
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Diabetes
  • Diabete Type 2
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Diabetes Type 1
  • Diabetes Mellitus
Intervention  ICMJE 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  ICMJE 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 20, 2021)
312
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 28, 2023
Estimated Primary Completion Date October 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angelica Al Janabi, MPH 213-764-4550 nativedm@usc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05088616
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Claradina Soto, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE
  • Project Angel Food
  • United American Indian Involvement, Inc.
Investigators  ICMJE
Principal Investigator: Claradina Soto, PhD, MPH University of Southern California
PRS Account University of Southern California
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP