Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT05472441
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Mid-Ohio Food Farmacy — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 6, 2023
Status verified
Aug 2025
Primary completion
Jul 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
568 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change in Hemoglobin A1c [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical CenterColumbusOhio43210
Ashley Mintos, BS, CCRC
[email protected]
(614) 366-5504
Joshua J Joseph, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
The Ohio State University Wexner Medical Center· Columbus, OH

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