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NCT Number: NCT05472441

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.

Recruiting

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Food Deprivation Glucose Metabolism Disorders Malnutrition Metabolic Diseases Nutrition Disorders Nutrition Poor Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Ashley Mintos, BS, CCRC

CONTACT

[email protected]

(614) 366-5504

Joshua J Joseph, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mid-Ohio Food Farmacy

Behavioral

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

Mid-Ohio Food Farmacy + Cooking for Diabetes

Behavioral

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.

Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub

Behavioral

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.

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

Behavioral

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.

Primary outcomes

  1. Change in Hemoglobin A1c

    Time frame: 3 months

    measures average blood sugar levels over the past 3 months

Secondary outcomes

  1. Change in Hemoglobin A1c

    Time frame: 6 months

    measures average blood sugar levels over the past 3 months

  2. Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale

    Time frame: 3 months

    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. Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale

    Time frame: 6 months

    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.

  4. Change in food security assessed using the 18-item U.S. Household Food Security Survey Module

    Time frame: 3 months

    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

  5. Change in food security assessed using the 18-item U.S. Household Food Security Survey Module

    Time frame: 6 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Walker, PhD

CONTACT

[email protected]

614-293-2428

Luiza Reopell, BS

CONTACT

[email protected]

614-653-8213

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2022
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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