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Education and Produce Provision for Diabetes

N/A

Recruiting

Led By Daniel Walker, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 2 Diabetes based on American Diabetes Association Criteria

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if giving food, teaching about diabetes, and connecting to resources can improve diabetes control in people with limited food access.

Who is the study for?

This trial is for people with type 2 diabetes who also struggle to get enough food (food insecurity) and have high blood sugar levels, as shown by a hemoglobin A1c of 7.5% or more. Participants must be willing to share their information with the Mid-Ohio Food Collective.

What is being tested?

The LINK trial is testing whether giving out fresh produce, teaching about cooking for diabetes, and connecting participants to community resources can help lower blood sugar levels in those facing both diabetes and food shortages.

What are the potential side effects?

Since this study involves dietary changes and education rather than medication, side effects are minimal but may include discomfort from lifestyle adjustments or allergic reactions to new foods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Type 2 Diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Hemoglobin A1c

Secondary study objectives

Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale

Change in food security assessed using the 18-item U.S. Household Food Security Survey Module

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways HubExperimental Treatment1 Intervention

The Food Farmacy + Health Impact Ohio Pathways Hub Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and has social needs address through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs.

Group II: Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways HubExperimental Treatment1 Intervention

The Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub Arm receives all 3 interventions. Participants receive weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective, Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention and has social needs addressed through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs.

Group III: Mid-Ohio Food Farmacy + Cooking for DiabetesExperimental Treatment1 Intervention

The Food Farmacy + Cooking for Diabetes Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention.

Group IV: Mid Ohio Food FarmacyActive Control1 Intervention

The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective.

0 / 1Eligibility criteria met