DiabetesNADPNCT05088616
Native American Diabetes Project
A study testing Virtual Diabetes Wellness Classes and Medically Tailored Meals in people with Diabetes and Diabete Type 2, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabete Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- Virtual Diabetes Wellness Classes and Medically Tailored Meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- Pregnancy,
- Food allergies,
- Serious non-allergic reactions to foods, and
- Unable or unwilling to eat study meals (considering the limited accommodations available).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90032
About this study
Official title: Community Partnered Medical Nutrition Intervention for Native Americans Living with Diabetes
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.
Read the 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.
- Conditions
- Diabetes, Diabete Type 2, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Type 1, Diabetes Mellitus
- Being tested
- Virtual Diabetes Wellness Classes and Medically Tailored Meals
- 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
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Social Isolation, Behavior, Chronic Disease, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Diabetes Wellness Classes and Medically Tailored MealsBehavioural
Four weeks of virtual diabetes wellness classes and 12 weeks of medically tailored meals.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual Diabetes Wellness Classes and Medically Tailored Meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1c (from baseline to 90 days and 180 days)
Measured: Baseline, 90 days, and 180 days
Secondary outcomes (5)
Change in blood pressure (from baseline to 90 days and 180 days)
Measured: Baseline, 90 days, and 180 days
Change in BMI (using weight and height) (from baseline to 90 days and 180 days)
Measured: Baseline, 90 days, and 180 days
Change in social isolation (using loneliness measure survey questions) (from baseline to 90 days and 180 days)
Measured: 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)
Measured: 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)
Measured: Baseline, 90 days, and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start28 Oct 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Why it stopped: The study was stopped primarily due to challenges recruiting and retaining participants. The investigators repeatedly tried to address this issue but still faced major challenges. Follow-up research was done to explore this challenge further.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Project Angel Food, United American Indian Involvement, Inc.
- Responsible party
- Principal investigator, Claradina Soto, University of Southern California
- Investigators
- Claradina Soto, PhD, MPH, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088616
- Sponsor's protocol ID
- UP-20-01441
- Acronym
- NADP
- Status last verified
- Jan 2025
- First submitted
- 8 Oct 2021
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: While we understand the value of data sharing, research with Native American communities is particularly sensitive due to data sovereignty and past abuses, including the use of Native people's data for purposes the people didn't know about or agree to, sometimes causing harm to the community. Our informed consent states that even deidentified participant data will not be used or distributed for further studies. We made this choice out of respect for the data considerations here and also to ensure potential participants feel as comfortable as possible when participating, as recruitment can already be challenging.
Publications
Centers for Disease Control and Prevention. (2020). National diabetes statistics report. https://www.cdc.gov/diabetes/data/statistics-report/index.html
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.
PubMed 31161137Office 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
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Partnered Medical Nutrition Intervention for Native Americans Living with Diabetes
- ClinicalTrials.gov ID
- NCT05088616
- Acronym / sponsor ID
- NADP / UP-20-01441
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped primarily due to challenges recruiting and retaining participants. The investigators repeatedly tried to address this issue but still faced major challenges. Follow-up research was done to explore this challenge further.
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Project Angel Food, United American Indian Involvement, Inc.
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Virtual Diabetes Wellness Classes and Medically Tailored Meals | Experimental | Behavioral: Virtual Diabetes Wellness Classes and Medically Tailored MealsAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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),
Key exclusion criteria (4 listed)
- Pregnancy,
- Food allergies,
- Serious non-allergic reactions to foods, and
- Unable or unwilling to eat study meals (considering the limited accommodations available).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Diabetes Wellness Classes and Medically Tailored MealsFour weeks of virtual diabetes wellness classes and 12 weeks of medically tailored meals. | Behavioural | Virtual Diabetes Wellness Classes and Medically Tailored Meals |
Primary outcome
Change in A1c (from baseline to 90 days and 180 days)
Time frame: Baseline, 90 days, and 180 days
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: The study was stopped primarily due to challenges recruiting and retaining participants. The investigators repeatedly tried to address this issue but still faced major challenges. Follow-up research was done to explore this challenge further.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- BackgroundCenters for Disease Control and Prevention. (2020). National diabetes statistics report. https://www.cdc.gov/diabetes/data/statistics-report/index.html
- Background: PubMed 31161137Garcia 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.
- BackgroundOffice 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
- BackgroundUCLA 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
- Individual participant dataSharing planned: No. While we understand the value of data sharing, research with Native American communities is particularly sensitive due to data sovereignty and past abuses, including the use of Native people's data for purposes the people didn't know about or agree to, sometimes causing harm to the community. Our informed consent states that even deidentified participant data will not be used or distributed for further studies. We made this choice out of respect for the data considerations here and also to ensure potential participants feel as comfortable as possible when participating, as recruitment can already be challenging.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claradina Soto, PhD, MPH principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Diabetes Wellness Classes and Medically Tailored Meals in people with Diabetes and Diabete Type 2, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped primarily due to challenges recruiting and retaining participants. The investigators repeatedly tried to address this issue but still faced major challenges. Follow-up research was done to explore this challenge further.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in A1c (from baseline to 90 days and 180 days) (time frame: Baseline, 90 days, and 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05088616, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.