Dysautonomia International

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

Purpose

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.

Conditions

Diabetes Mellitus, Type 2
Nutrition Poor
Food Deprivation

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The LINK pragmatic randomized controlled trial (pRCT) uses 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 randomized using a 1:1:1:1 stratified randomization scheme built into Research Electronic Data Capture (REDCap) at the participant level.
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
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.	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.
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.	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 + 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.
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.	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.
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.	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.

Recruiting Locations

The Ohio State University Wexner Medical Center
Columbus, Ohio 43210

Contact:
Ashley Mintos, BS, CCRC
614-366-5504
Ashley.Mintos@osumc.edu

More Details

Status: Recruiting
Sponsor: Ohio State University

Study Contact

Luiza Reopell, BS
614-653-8213
luiza.reopell@osumc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.