Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK132403 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mid Ohio Food Farmacy | Active Comparator | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | measures average blood sugar levels over the past 3 months | 3 months |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luiza Reopell, BS | Contact | 614-653-8213 | luiza.reopell@osumc.edu | |
| Daniel Walker, PhD | Contact | 614-293-2428 | Daniel.Walker@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Joseph, MD, MPH | Ohio State University | Principal Investigator |
| Daniel Walker, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42052990 | Derived | 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. | |
| 37121390 | Derived | 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. |
Not provided
Not provided
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.
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.
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.
Not provided
Not provided
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.
Not provided
Not provided
Not provided
|
| 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. |
|
| 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:
For households with no child present:
| 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:
For households with no child present:
| 6 months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D003296 | Cooking |
| ID | Term |
|---|---|
| D005511 | Food Handling |
| D019649 | Food Industry |
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided