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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
568
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 Ohio State University Wexner Medical Center
Columbus, Ohio, United States
RECRUITINGChange in Hemoglobin A1c
measures average blood sugar levels over the past 3 months
Time frame: 3 months
Change in Hemoglobin A1c
measures average blood sugar levels over the past 3 months
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
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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.
Time frame: 6 months