Native American Diabetes Project

NCT05088616 | Terminated

• 1 other identifier: UP-20-01441
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in A1c (from baseline to 90 days and 180 days)

  Baseline, 90 days, and 180 days

Secondary Outcomes (5)

• Change in blood pressure (from baseline to 90 days and 180 days)

  Baseline, 90 days, and 180 days

• Change in BMI (using weight and height) (from baseline to 90 days and 180 days)

  Baseline, 90 days, and 180 days

• Change in social isolation (using loneliness measure survey questions) (from baseline to 90 days and 180 days)

  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)

  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)

  Baseline, 90 days, and 180 days

Study Arms (1)

Virtual Diabetes Wellness Classes and Medically Tailored Meals

EXPERIMENTAL

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

Interventions

Virtual Diabetes Wellness Classes and Medically Tailored Meals BEHAVIORAL

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

Virtual Diabetes Wellness Classes and Medically Tailored Meals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reside in Los Angeles County,
• 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.

You may not qualify if:

• Pregnancy,
• Food allergies,
• Serious non-allergic reactions to foods, and
• Unable or unwilling to eat study meals (considering the limited accommodations available).

Sponsors & Collaborators

• University of Southern California: lead
• Project Angel Food: collaborator
• United American Indian Involvement, Inc.: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90032, United States

Location

Related Publications (4)

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

  BACKGROUND

• 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.

  PMID: 31161137 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Social Isolation; Behavior; Chronic Disease; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Social Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claradina Soto, PhD, MPH

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants receive the same intervention.

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 22, 2021
• Study Start: October 28, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)