Food and Resources Expanded to Support Health and Type 2 Diabetes

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT06211270
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FRESH — BEHAVIORAL
    FRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration

Study Details

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.

Key Dates

Start date
Sep 13, 2023
Status verified
Dec 2024
Primary completion
Oct 24, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    FRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration
  • Other: Wait-Listed Control
    Standard of Care for El Rio Community Health Center persons with type 2 diabetes.

Primary Outcome Measure

Acceptability Aim 1 [ Time Frame: 6 months (post-intervention) ]

Locations (1)

FacilityCityStateZIPSite coordinators
El Rio Community Health CenterTucsonArizona85701-

Find similar trials in Tucson, AZ

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
El Rio Community Health Center· Tucson, AZ

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