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NCT05472441NARecruiting

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

Ohio State University

Start Date

2/6/2023

Completion Date

10/1/2026

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.

Detailed Description

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

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Mid-Ohio Food Farmacy

BEHAVIORAL

Mid-Ohio Food Farmacy + Cooking for Diabetes

BEHAVIORAL

Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub

BEHAVIORAL

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

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Conditions

Diabetes Mellitus, Type 2Nutrition PoorFood Deprivation

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States