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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472441
• Other study ID #: 2022H0045
• Secondary ID: R01DK132403
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: Luiza Reopell, BS
• Phone: 614-653-8213
• Email: luiza.reopell[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 568
• Est. completion date: October 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Food Deprivation
• Malnutrition
• Nutrition Poor

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c	measures average blood sugar levels over the past 3 months	3 months
Secondary	Change in Hemoglobin A1c	measures average blood sugar levels over the past 3 months	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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