Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mid-Ohio Food Farmacy, Mid-Ohio Food Farmacy + Cooking for Diabetes, Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub, Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Nutrition Poor, Food Deprivation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 p
Primary outcome measures
- Change in Hemoglobin A1c [Time frame: 3 months]
Secondary outcome measures (5)
- Change in Hemoglobin A1c [Time frame: 6 months]
- Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale [Time frame: 3 months]
- Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale [Time frame: 6 months]
- Change in food security assessed using the 18-item U.S. Household Food Security Survey Module [Time frame: 3 months]
- Change in food security assessed using the 18-item U.S. Household Food Security Survey Module [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The Ohio State University Wexner Medical Center — Columbus
Publications
- Gilmore D, Bunger A, Garrity K, Bose-Brill S, Scheck McAlearney A, Hefner JL, Seiber E, Garner JA, Headings A, Joseph JJ, Walker DM. Defining the Social Needs Service Cascade: Evidence From A Multistakeholder Qualitative Study. Med Care Res Rev. 2026 Apr 29:10775587261439173. doi: 10.1177/10775587261439173. Online ahead of print. PMID 42052990
- Walker DM, Garner JA, Hefner JL, Headings A, Jonas DE, Clark A, Bose-Brill S, Nawaz S, Seiber E, McAlearney AS, Brock G, Zhao S, Reopell L, Coovert N, Shrodes JC, Spees CK, Sieck CJ, Di Tosto G, DePuccio MJ, Williams A, Hoseus J, Baker C, Brown MM, Joseph JJ. Rationale and design of the linking education, produce provision, and community referrals to improve diabetes care (LINK) study. Contemp Cli PMID 37121390
Identifiers
NCT: NCT05472441 · 2022H0045 · R01DK132403