Recruiting

Diabetes Care

Sponsor:

Ohio State University

Code:

NCT05472441

Conditions

Diabetes Mellitus, Type 2

Nutrition Poor

Food Deprivation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mid-Ohio Food Farmacy

Mid-Ohio Food Farmacy + Cooking for Diabetes

Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub

Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus, Type 2

Nutrition Poor

Food Deprivation

Study ID

NCT05472441

Start date

Feb 6, 2023

Status verified date

Aug, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

568 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

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.

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.

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.

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 measure

  • Change in Hemoglobin A1c [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Luiza Reopell, BS

614-653-8213luiza.reopell@osumc.edu

Daniel Walker, PhD

614-293-2428Daniel.Walker@osumc.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Ashley Mintos, BS, CCRC

(614) 366-5504Ashley.Mintos@osumc.edu

Principal Investigator:

Joshua J Joseph, MD

More Information

Sponsor

Ohio State University

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Keywords

  • Food Insecurity
  • Social Determinants of Health
  • Non-medical, health related social needs
  • Diabetes Self-Management Education and Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-08-11.