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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

No Placebo-Only Group

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:

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I cannot speak or read English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3- and 6 months (post-intervention), and 12 months (follow-up)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability Aim 1

Adaptation

Demand

+4 more

Secondary study objectives

Body Mass Index

Body weight

Demographics and Social Determinants of Health

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met