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

The Ohio State University

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2; Food Deprivation; Nutrition Poor

Treatments: Behavioral: Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub; Behavioral: Mid-Ohio Food Farmacy; Behavioral: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub; Behavioral: Mid-Ohio Food Farmacy + Cooking for Diabetes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05472441

R01DK132403 (U.S. NIH Grant/Contract)

2022H0045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 568 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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568 participants in 4 patient groups

Mid Ohio Food Farmacy

Active Comparator group

Description:

The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective.

Treatment:

Behavioral: Mid-Ohio Food Farmacy

Mid-Ohio Food Farmacy + Cooking for Diabetes

Experimental group

Description:

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.

Treatment:

Behavioral: Mid-Ohio Food Farmacy + Cooking for Diabetes

Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub

Experimental group

Description:

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.

Treatment:

Behavioral: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub

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

Experimental group

Description:

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.

Treatment:

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