NCT05472441

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 568 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2
• Nutrition Poor
• Food Deprivation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-06
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2022-07-25
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States