FRESH for Type 2 Diabetes
(FRESH Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Arizona

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?Food insecurity, poor nutrition, and economic disadvantage are critical social determinants of health that contribute to disparities in type 2 diabetes mellitus (T2DM), a serious diet-sensitive chronic disease affecting more than 20% of food insecure adults. There is a demonstrable need for food-focused interventions to address the diet quality of persons with, or at risk of, T2DM. Completion of the pilot study will produce recruitment, retention, adherence, and cost data for a future definitive randomized controlled clinical trial, bringing us closer to the long-term goal of a tested, efficacious model of diabetes care coordinated across Federally Qualified Health Centers and food bank networks.

Eligibility Criteria

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.

Inclusion Criteria

Willingness to participate in all study activities (Section C.6) for the duration of the study (12 months on study, including 6 months of intervention)

I am 18 years old or older.

I have been diagnosed with type 2 diabetes by a doctor.

+5 more

Exclusion Criteria

Inability to read and write

No home phone or home address

I cannot speak or read English or Spanish.

+2 more

Participant Groups

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.

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