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FRESH for Type 2 Diabetes (FRESH Trial)

N/A
Waitlist Available
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult (ages 18+)
Physician diagnosis of T2DM
Must not have
Not able to speak and read English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3- and 6 months (post-intervention), and 12 months (follow-up)
Awards & highlights

Summary

This trial is focused on addressing the impact of food insecurity, poor nutrition, and economic disadvantage on type 2 diabetes. The goal is to gather data on recruitment, retention, adherence, and cost for

Who is the study for?
This trial is for adults with type 2 diabetes who struggle to get enough food and have a poor diet, which can make their condition worse. It's especially aimed at those facing economic hardships that affect their ability to manage diabetes.
What is being tested?
The FRESH program is being tested in this study. It aims to improve the health of people with type 2 diabetes by providing better access to nutritious food and resources, potentially leading to a new model of care.
What are the potential side effects?
Since this intervention involves dietary changes rather than medication, side effects may include adjustments in blood sugar levels as diet improves. Participants will be monitored for any negative reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with type 2 diabetes by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot speak or read English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3- and 6 months (post-intervention), and 12 months (follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3- and 6 months (post-intervention), and 12 months (follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability Aim 1
Adaptation
Demand
+4 more
Secondary outcome measures
Body Mass Index
Body weight
Demographics and Social Determinants of Health
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Wait-Listed ControlExperimental Treatment1 Intervention
Standard of Care for El Rio Community Health Center persons with type 2 diabetes.
Group II: InterventionExperimental Treatment1 Intervention
FRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
518 Previous Clinical Trials
148,659 Total Patients Enrolled
El Rio Community Health CenterOTHER
3 Previous Clinical Trials
857 Total Patients Enrolled
Arizona State UniversityOTHER
288 Previous Clinical Trials
109,261 Total Patients Enrolled
~17 spots leftby Mar 2025
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