Clinical trial NCT05088616: Native American Diabetes Project
Official title: Community Partnered Medical Nutrition Intervention for Native Americans Living with Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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
Tribal
Indigenous
Native
Social interaction
Diabetes
Blood sugar
Buddy
Urban Indian
Urban
online classes
virtual classes
Los Angeles
AIAN
Los Angeles County
A1c
blood
clinic
diabetes education
public health
social
social isolation
isolation
behavior
behavioral
culture
cultural connectedness
connection
well-being
population
population health
adults
urban population
race
chronic disease
food
healthy food
patient education
North America
California
Southern California
Pacific States
United States
ethnic and racial minorities
Indians, North American
Indigenous peoples
endocrine system diseases
diabetes mellitus
sugar
diet
meal delivery
early termination of clinical trials
surveys
Zoom
labs
blood test
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Project Angel Food
name: United American Indian Involvement, Inc.
First posted: 2021-10-22
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive the same intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is for American Indian and Alaska Native (AIAN) people with diabetes in Los Angeles County, California. Participants (people who join the study) are signed up for a program that includes healthy meals, online diabetes classes, and social support.

This study aims to answer the following question:

Can this program (the meals, classes, and social support) have health and well-being benefits for participants, like lower blood sugar levels and less social isolation?

Participants are asked to fill out surveys and go to three clinic visits. Participants do not have to pay for the clinic visits or any other parts 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 was originally to reach up to 312 Native Americans with diabetes (later reduced, aiming for 150) 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. Each participant will be part of a 180-day cohort, during which participants will complete surveys and attend three clinic visits.

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 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).

Primary outcomes:
measure: Change in A1c (from baseline to 90 days and 180 days)
timeFrame: Baseline, 90 days, and 180 days
Secondary outcomes:
measure: Change in blood pressure (from baseline to 90 days and 180 days)
timeFrame: Baseline, 90 days, and 180 days
measure: Change in BMI (using weight and height) (from baseline to 90 days and 180 days)
timeFrame: Baseline, 90 days, and 180 days
measure: Change in social isolation (using loneliness measure survey questions) (from baseline to 90 days and 180 days)
timeFrame: Baseline, 90 days, and 180 days
measure: Change in level of diabetes distress (using diabetes distress scale survey responses) (from baseline to 90 days and 180 days)
timeFrame: Baseline, 90 days, and 180 days
measure: 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)
timeFrame: Baseline, 90 days, and 180 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Claradina Soto, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Centers for Disease Control and Prevention. (2020). National diabetes statistics report. https://www.cdc.gov/diabetes/data/statistics-report/index.html
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.
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
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