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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Nutrition Poor, Food Deprivation

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mid Ohio Food Farmacy<br>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<br>* The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective.<br>|
| Experimental: Mid-Ohio Food Farmacy + Cooking for Diabetes<br>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<br>* 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.<br>|
| Experimental: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub<br>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<br>* 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.<br>|
| Experimental: Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Insecurity, Social Determinants of Health, Non-medical, health related social needs, Diabetes Self-Management Education and Support