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Recruiting

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

NCT05472441 · Ohio State University
In plain English

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About this study
LINK (Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care is a 6-month pragmatic randomized controlled trial (pRCT) using a 2x2 factorial design to prospectively enroll study participants with type 2 diabetes and food insecurity into one of four study arms. The four study arms are: 1) Mid-Ohio Farmacy (receiving weekly produce through a consortium of local food banks); 2) Mid-Ohio Farmacy + Cooking for Diabetes (Cooking for Diabetes is a 6-week diabetes and culinary education intervention); 3) Mid-Ohio Farmacy + Health Impact Ohio Pathways Hub (The Pathways Hub uses a community health worker model to meet with participants, evaluate and address non-medical, health-related social needs); and 4) Mid-Ohio Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub). Participants will be enter Participants will be randomized using a 1:1:1:1 stratified randomization scheme built into Research Electronic Data Capture (REDCap) at the participant level. Primary and secondary outcomes will be collected at baseline, 3 and 6 months.
Eligibility criteria
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 target: 568 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-02-06
Estimated completion: 2026-10-01
Last updated: 2025-08-11
Interventions
Behavioral: Mid-Ohio Food FarmacyBehavioral: Mid-Ohio Food Farmacy + Cooking for DiabetesBehavioral: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways HubBehavioral: Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub
Primary outcomes
  • Change in Hemoglobin A1c (3 months)
Sponsor
Ohio State University · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactLuiza Reopell, BS · contact · luiza.reopell@osumc.edu · 614-653-8213
ContactDaniel Walker, PhD · contact · Daniel.Walker@osumc.edu · 614-293-2428
InvestigatorJoshua Joseph, MD, MPH · principal_investigator, Ohio State University
InvestigatorDaniel Walker, PhD · principal_investigator, Ohio State University
All locations (1)
The Ohio State University Wexner Medical CenterRecruiting
Columbus, Ohio, United States
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK) · TrialPath