Studies
| Study First Submitted Date | 2021-10-08 |
| Study First Posted Date | 2021-10-22 |
| Last Update Posted Date | 2022-05-26 |
| Start Month Year | October 28, 2021 |
| Primary Completion Month Year | October 28, 2023 |
| Verification Month Year | May 2022 |
| Verification Date | 2022-05-31 |
| Last Update Posted Date | 2022-05-26 |
Detailed Descriptions
| Sequence: | 20752757 |
| 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). |
Facilities
| Sequence: | 200368386 |
| Status | Recruiting |
| Name | University of Southern California |
| City | Los Angeles |
| State | California |
| Zip | 90032 |
| Country | United States |
Facility Contacts
| Sequence: | 28143654 |
| Facility Id | 200368386 |
| Contact Type | primary |
| Name | Angelica Al Janabi, MPH |
| [email protected] | |
| Phone | 213-764-4550 |
Conditions
| Sequence: | 52250644 | Sequence: | 52250645 | Sequence: | 52250646 | Sequence: | 52250647 | Sequence: | 52250648 | Sequence: | 52250649 |
| Name | Diabetes | Name | Diabete Type 2 | Name | Diabetes Mellitus, Type 1 | Name | Diabetes Mellitus, Type 2 | Name | Diabetes Type 1 | Name | Diabetes Mellitus |
| Downcase Name | diabetes | Downcase Name | diabete type 2 | Downcase Name | diabetes mellitus, type 1 | Downcase Name | diabetes mellitus, type 2 | Downcase Name | diabetes type 1 | Downcase Name | diabetes mellitus |
Id Information
| Sequence: | 40216659 |
| Id Source | org_study_id |
| Id Value | UP-20-01441 |
Countries
| Sequence: | 42631567 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55682363 |
| Group Type | Experimental |
| Title | Virtual Diabetes Wellness Classes and Medically Tailored Meals |
| 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. |
Interventions
| Sequence: | 52563673 |
| Intervention Type | Behavioral |
| Name | Virtual Diabetes Wellness Classes and Medically Tailored Meals |
| Description | Four weeks of virtual diabetes wellness classes and 12 weeks of medically tailored meals. |
Keywords
| Sequence: | 79981463 | Sequence: | 79981464 | Sequence: | 79981465 | Sequence: | 79981466 | Sequence: | 79981467 | Sequence: | 79981468 | Sequence: | 79981469 | Sequence: | 79981470 | Sequence: | 79981471 | Sequence: | 79981472 | Sequence: | 79981473 | Sequence: | 79981474 | Sequence: | 79981475 | Sequence: | 79981476 | Sequence: | 79981477 | Sequence: | 79981478 | Sequence: | 79981479 | Sequence: | 79981480 | Sequence: | 79981481 | Sequence: | 79981482 |
| Name | American Indian | Name | Alaska Native | Name | Native American | Name | Education | Name | Wellness program | Name | Meals | Name | Nutrition | Name | Classes | Name | Virtual | Name | Remote | Name | Tribal | Name | Indigenous | Name | Native | Name | Social interaction | Name | Diabetes | Name | Blood sugar | Name | Buddy | Name | Los Angeles | Name | Urban Indian | Name | Urban |
| Downcase Name | american indian | Downcase Name | alaska native | Downcase Name | native american | Downcase Name | education | Downcase Name | wellness program | Downcase Name | meals | Downcase Name | nutrition | Downcase Name | classes | Downcase Name | virtual | Downcase Name | remote | Downcase Name | tribal | Downcase Name | indigenous | Downcase Name | native | Downcase Name | social interaction | Downcase Name | diabetes | Downcase Name | blood sugar | Downcase Name | buddy | Downcase Name | los angeles | Downcase Name | urban indian | Downcase Name | urban |
Design Outcomes
| Sequence: | 177669823 | Sequence: | 177669824 | Sequence: | 177669825 | Sequence: | 177669826 | Sequence: | 177669827 | Sequence: | 177669828 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Change in A1c (from baseline to 90 days and 180 days) | Measure | Change in blood pressure (from baseline to 90 days and 180 days) | Measure | Change in BMI (using weight and height) (from baseline to 90 days and 180 days) | Measure | Change in social isolation (using loneliness measure survey questions) (from baseline to 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) | 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) |
| Time Frame | Baseline, 90 days, and 180 days | Time Frame | Baseline, 90 days, and 180 days | Time Frame | Baseline, 90 days, and 180 days | Time Frame | Baseline, 90 days, and 180 days | Time Frame | Baseline, 90 days, and 180 days | Time Frame | Baseline, 90 days, and 180 days |
Browse Conditions
| Sequence: | 193790930 | Sequence: | 193790931 | Sequence: | 193790932 | Sequence: | 193790933 | Sequence: | 193790934 | Sequence: | 193790935 | Sequence: | 193790936 | Sequence: | 193790937 |
| Mesh Term | Diabetes Mellitus | Mesh Term | Diabetes Mellitus, Type 2 | Mesh Term | Diabetes Mellitus, Type 1 | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases | Mesh Term | Endocrine System Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases |
| Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | diabetes mellitus, type 2 | Downcase Mesh Term | diabetes mellitus, type 1 | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | endocrine system diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48393977 | Sequence: | 48393978 | Sequence: | 48393979 |
| Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
| Name | University of Southern California | Name | Project Angel Food | Name | United American Indian Involvement, Inc. |
Overall Officials
| Sequence: | 29328631 |
| Role | Principal Investigator |
| Name | Claradina Soto, PhD, MPH |
| Affiliation | University of Southern California |
Central Contacts
| Sequence: | 12027243 |
| Contact Type | primary |
| Name | Angelica Al Janabi, MPH |
| Phone | 213-764-4550 |
| [email protected] | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68256523 |
| Design Group Id | 55682363 |
| Intervention Id | 52563673 |
Eligibilities
| Sequence: | 30811770 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| 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). |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254046587 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 5 |
Designs
| Sequence: | 30557745 |
| Allocation | N/A |
| Intervention Model | Single Group Assignment |
| Observational Model | |
| Primary Purpose | Supportive Care |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 28924134 |
| Responsible Party Type | Principal Investigator |
| Name | Claradina Soto |
| Title | Assistant Professor |
| Affiliation | University of Southern California |
Study References
| Sequence: | 52150074 | Sequence: | 52150075 | Sequence: | 52150076 | Sequence: | 52150077 |
| Pmid | 31161137 | ||||||
| Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
| 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-Datatopic-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 |