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

Not Applicable

Recruiting

• Conditions: Nutrition Poor; Food Deprivation; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Mid-Ohio Food Farmacy + Cooking for Diabetes; Behavioral: Mid-Ohio Food Farmacy; Behavioral: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub; Behavioral: Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub

• Registration Number: NCT05472441
• Lead Sponsor: Ohio State University

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.

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 Timeline

• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Study Start: 2023-02-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2026-07-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 568

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Mid-Ohio Food Farmacy + Cooking for Diabetes	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	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 + Health Impact Ohio Pathways Hub	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	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.

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c	3 months	measures average blood sugar levels over the past 3 months

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c	6 months	measures average blood sugar levels over the past 3 months
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
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.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States