Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
2 other identifiers
interventional
568
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Feb 2023
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedStudy Start
First participant enrolled
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
August 11, 2025
August 1, 2025
3.4 years
July 21, 2022
August 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hemoglobin A1c
measures average blood sugar levels over the past 3 months
3 months
Secondary Outcomes (5)
Change in Hemoglobin A1c
6 months
Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
3 months
Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
6 months
Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
3 months
Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
6 months
Study Arms (4)
Mid Ohio Food Farmacy
ACTIVE COMPARATORThe 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
EXPERIMENTALThe 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
EXPERIMENTALThe 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
EXPERIMENTALThe 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.
Interventions
The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes based on American Diabetes Association Criteria
- Hemoglobin A1c ≥ 7.5%
- Screen Positive on 2-item Food Security Screener
You may not qualify if:
- Unwilling to Attest to Release of Information to Mid-Ohio Food Collective
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Related Publications (1)
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 Clin Trials. 2023 Jul;130:107212. doi: 10.1016/j.cct.2023.107212. Epub 2023 Apr 28.
PMID: 37121390DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Joseph, MD, MPH
Ohio State University
- PRINCIPAL INVESTIGATOR
Daniel Walker, PhD
Ohio State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
July 21, 2022
First Posted
July 25, 2022
Study Start
February 6, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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.
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.