NCT05472441 · Ohio State University
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
What this study is about
This is a pragmatic randomly assigned controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity.
View original scientific description
This is a pragmatic randomized controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity.
Interventions
BEHAVIORAL
Mid-Ohio Food Farmacy
The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective.
BEHAVIORAL
Mid-Ohio Food Farmacy + Cooking for Diabetes
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.
BEHAVIORAL
Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub
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.
BEHAVIORAL
Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub
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.
Primary outcome measures
Change in Hemoglobin A1c
Time frame: 3 months
measures average blood sugar levels over the past 3 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Type 2 Diabetes based on American Diabetes Association Criteria
- Hemoglobin A1c ≥ 7.5%
- Screen Positive on 2-item Food Security Screener
Exclusion criteria
- Unwilling to Attest to Release of Information to Mid-Ohio Food Collective
Where
- Columbus, Ohio
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 11, 2025 · Source of record for eligibility and locations