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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Nutrition Poor; Food Deprivation
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 568
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luiza Reopell, BS; Phone Number: 614-653-8213; Email: luiza.reopell@osumc.edu
• Study Contact Backup: Name: Daniel Walker, PhD; Phone Number: 614-293-2428; Email: daniel.walker@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Principal Investigator: Joshua J Joseph, MD
      • Contact: Ashley Mintos, BS, CCRC; Phone Number: (614) 366-5504; Email: Ashley.Mintos@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c	measures average blood sugar levels over the past 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c	measures average blood sugar levels over the past 3 months	6 months
Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale	Diabetes self-efficacy measured via the diabetes self-efficacy scale. The Diabetes Self-Efficacy Scale has a minimum score of 10 and a maximum score of 80. A higher score indicates higher diabetes self-efficacy.	3 months
Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale	Diabetes self-efficacy measured via the diabetes self-efficacy scale. The Diabetes Self-Efficacy Scale has a minimum score of 10 and a maximum score of 80. A higher score indicates higher diabetes self-efficacy.	6 months
Change in food security assessed using the 18-item U.S. Household Food Security Survey Module	Food security will be assessed using the 18-item U.S. Household Food Security Survey Module. For households with one or more children: Raw score zero-High food security; Raw score 1-2-Marginal food security; Raw score 3-7-Low food security; Raw score 8-18-Very low food security For households with no child present: Raw score zero-High food security; Raw score 1-2-Marginal food security; Raw score 3-5-Low food security; Raw score 6-10-Very low food security	3 months
Change in food security assessed using the 18-item U.S. Household Food Security Survey Module	Food security will be assessed using the 18-item U.S. Household Food Security Survey Module. For households with one or more children: Raw score zero-High food security; Raw score 1-2-Marginal food security; Raw score 3-7-Low food security; Raw score 8-18-Very low food security For households with no child present: Raw score zero-High food security; Raw score 1-2-Marginal food security; Raw score 3-5-Low food security; Raw score 6-10-Very low food security	6 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Joshua Joseph, MD, MPH, Ohio State University; Principal Investigator: Daniel Walker, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Social Determinants of Health; Food Insecurity; Non-medical, health related social needs; Diabetes Self-Management Education and Support
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Glucose Metabolism Disorders; Malnutrition; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2022H0045; R01DK132403 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available to the public as immediately and broadly as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. All research data will be shared as requested in accordance with federal regulations, the Freedom of Information Act (FOIA). Requests from researchers will be reviewed by the project investigators, and we will provide the requesting researcher with the minimum necessary data; the shared data will not have any individual participant identifiers or specific clinic identifiers.
• IPD Sharing Time Frame: Data will be made available to the public as immediately and broadly as possible while safeguarding the privacy of participants and protecting confidential and proprietary data.

IPD Sharing Access Criteria

Requests will be reviewed by the project investigators (PI). In accordance with NIH policies and procedures regarding data use and data sharing, user registration will be required to access the files. Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistributions of the data to third parties, and proper acknowledgement of the data resource. Any presentations, abstracts, or publications must include an acknowledgement/reference of the LINK research team.

The requesting researcher(s) will be notified that they may only use the data for the purposes for which the data were requested and only by the individuals listed in the request. The requesting researcher(s) will be responsible for notifying the PI upon completion of analysis indicating the way the data were destroyed.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No