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Procedure
Wellness Classes + Tailored Meals for Diabetes
N/A
Waitlist Available
Led By Claradina Soto, PhD, MPH
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years and older
Be older than 18 years old
Must not have
Unable or unwilling to eat study meals (considering the limited accommodations available)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the feasibility of a diabetes intervention for AIAN people that includes culturally tailored meals and virtual diabetes wellness classes.
Who is the study for?
This trial is for Native Americans in Los Angeles County, aged 18 or older with diabetes, who can attend virtual classes and clinic visits during weekdays. Participants must speak English, complete surveys via email, have freezer space for meals, and commit to attending most of the initial sessions.
What is being tested?
The study tests a holistic approach to improve health among Native Americans with diabetes by providing medically tailored meals for 12 weeks and hosting four weekly virtual wellness classes aimed at reducing blood sugar levels and social isolation.
What are the potential side effects?
There are no direct medical side effects listed from participating in this trial as it involves educational classes and meal plans rather than medication. However, participants may experience changes in diet or lifestyle adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot or do not want to follow the diet required by the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Virtual Diabetes Wellness Classes and Medically Tailored MealsExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Project Angel FoodUNKNOWN
United American Indian Involvement, Inc.UNKNOWN
University of Southern CaliforniaLead Sponsor
942 Previous Clinical Trials
1,604,244 Total Patients Enrolled
4 Trials studying Diabetes
895 Patients Enrolled for Diabetes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend classes online using Zoom.I am 18 years old or older.I cannot or do not want to follow the diet required by the study.I have enough freezer space for 14 meals.I can attend at least five of the first six classes/meetings.I can complete surveys sent to me via email.I have diabetes.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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