Native American Diabetes Project (NCT05088616) | Clinical Trial Compass
TerminatedNot Applicable
Native American Diabetes Project
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.
United States53 participantsStarted 2021-10-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,
Exclusion criteria
✕. Pregnancy,
✕. Food allergies,
✕. Serious non-allergic reactions to foods, and
✕
What they're measuring
1
Change in A1c (from baseline to 90 days and 180 days)