Clinical trial NCT05472441: Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Official title: Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Nutrition Poor
Food Deprivation
Keywords: Food Insecurity
Social Determinants of Health
Non-medical, health related social needs
Diabetes Self-Management Education and Support
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-07-25
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: 3 months
Secondary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: 6 months
measure: Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
timeFrame: 3 months
measure: Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
timeFrame: 6 months
measure: Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
timeFrame: 3 months
measure: Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
timeFrame: 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Joshua Joseph, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Daniel Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References: