Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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
The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective.
|
| Experimental: 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 + 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.
|
| Experimental: 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 + 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.
|
| Experimental: 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 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 participants, evaluates and addresses non-medical, health-related social needs.
|
Outcome Measures
Primary Outcome Measures
- Change in Hemoglobin A1c [3 months]
measures average blood sugar levels over the past 3 months
Secondary Outcome Measures
- Change in Hemoglobin A1c [6 months]
measures average blood sugar levels over the past 3 months
- Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale [3 months]
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.
- Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale [6 months]
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.
- Change in food security assessed using the 18-item U.S. Household Food Security Survey Module [3 months]
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
- Change in food security assessed using the 18-item U.S. Household Food Security Survey Module [6 months]
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
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ohio State University
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Joshua Joseph, MD, MPH, Ohio State University
- Principal Investigator: Daniel Walker, PhD, Ohio State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022H0045
- R01DK132403