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Virtual Diabetes Wellness Classes and Medically 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 90 days, and 180 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 90 days, and 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 90 days, and 180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in A1c (from baseline to 90 days and 180 days)
Secondary outcome measures
Change in BMI (using weight and height) (from baseline to 90 days and 180 days)
Change in blood pressure (from baseline to 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)
+2 moreTrial 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
905 Previous Clinical Trials
1,596,006 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the intake capacity for this research project?
"Affirmative. According to clinicaltrials.gov, the medical trial that was first made public on October 28th 2021 is still actively recruiting participants. 312 individuals are required from one location in order for this project to be successful."
Answered by AI
Is registration currently available for this experiment?
"Clinicaltrials.gov confirms that this medical trial, which was initially posted on October 28th 2021, is still accepting participants and has been updated as recently as May 22nd 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
University of Southern California
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am on 4 -Type 2 Diabetes medications and still coming up over 7.0% HBA1C. I'm not suffering from any long term diabetes complications like neuropathy, retinopathy, kidney failure and need for dialysis. However, I'm concerned that if my HBA1C continues to be high that I will progress in that directions, which I'm trying to avoid.
I'm open to try anything that will help the accomplishment of those goals for me as well as provide research to help others.
PatientReceived 1 prior treatment
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