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Healthy Food Delivery + Lifestyle Intervention for Diabetes (ADELANTE Trial)
N/A
Recruiting
Led By Lisa Goldman Rosas, PhD, MPH
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age at enrollment: 12+ years for household members
Type 2 diabetes indicated in the electronic health record, e.g. as ICD-10 (International Classification of Diseases) diagnosis code or HbA1c value
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months through 12 months post-enrollment
Awards & highlights
ADELANTE Trial Summary
This trial will test if a food delivery and lifestyle intervention can better control diabetes and improve food insecurity in Latino patients.
Who is the study for?
This trial is for Latino individuals with type 2 diabetes who experience food insecurity, live in Alameda or Contra Costa County, and are involved in their household's nutrition. They must have a BMI of 25 or higher, be over 18 years old, not pregnant nor planning pregnancy within a year, and able to give informed consent.Check my eligibility
What is being tested?
ADELANTE is testing if weekly healthy food deliveries combined with an intensive lifestyle intervention (Vida Sana) can better improve blood sugar control compared to usual care among Latinos with diabetes after six months.See study design
What are the potential side effects?
Since the interventions involve dietary changes and lifestyle modifications rather than medications, side effects may include initial discomfort adjusting to new foods or exercise routines but no medical side effects are expected.
ADELANTE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 years old or older.
Select...
I have been diagnosed with Type 2 diabetes.
Select...
I am 18 years old or older.
ADELANTE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months through 12 months post-enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months through 12 months post-enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HgbA1c
Secondary outcome measures
Anxiety
Blood Pressure
Change in Body Mass Index (BMI)
+20 moreADELANTE Trial Design
2Treatment groups
Experimental Treatment
Group I: Waitlist Control GroupExperimental Treatment1 Intervention
The waitlist control will continue usual care with no intervention for 6 months. To balance rigor with ethical considerations, they will receive the healthy food box deliveries after a 6 month waiting period.
Group II: Food and Lifestyle Intervention GroupExperimental Treatment2 Interventions
The Food and Lifestyle Intervention Group will receive weekly household deliveries of healthy food as well as a lifestyle intervention (called Vida Sana) that will be delivered via Zoom and facilitated by a trained bilingual/bicultural health coach.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,340,990 Total Patients Enrolled
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La Clínica de La Raza Inc.OTHER
3 Previous Clinical Trials
785 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is 25 or higher.You plan to move away from the area in the next year.You are currently using drugs or have a mental disorder that would make it hard for you to take part in a group program or complete follow-up check-ups.I am 12 years old or older.You are responsible for buying and preparing food for your household and providing support for healthy eating.You have shown signs of not having enough food to eat based on a short questionnaire.I have been diagnosed with Type 2 diabetes.I am 18 years old or older.I am unable to understand or sign the consent form.You are getting medical care at a community health center that works with our organization.
Research Study Groups:
This trial has the following groups:- Group 1: Food and Lifestyle Intervention Group
- Group 2: Waitlist Control Group
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.
Is this trial enrolling participants at the present time?
"The records hosted on clinicaltrials.gov demonstrate that this particular study, which was originally published on June 1st 2023 and last updated on the 8th of June, is no longer enrolling patients. However, there are over two thousand other trials nationwide actively seeking candidates at present."
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