Improving diabetes care through education and food support
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
This study is testing if giving fresh fruits and vegetables, diabetes education, and community support can help people with type 2 diabetes who struggle with food insecurity manage their blood sugar better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 568 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05472441 on ClinicalTrials.gov |
What this trial studies
This pragmatic randomized controlled trial aims to evaluate the impact of providing fresh produce, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes facing food insecurity. Participants will be enrolled into one of four groups, each receiving different combinations of interventions over a 6-month period. The study employs a 2x2 factorial design and utilizes stratified randomization to ensure balanced groups. Outcomes will be assessed at baseline, 3 months, and 6 months to determine the effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with type 2 diabetes, with a hemoglobin A1c of 7.5% or higher, who also screen positive for food insecurity.
Not a fit: Patients who do not have type 2 diabetes or those who are unwilling to release information to the Mid-Ohio Food Collective may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve diabetes management and health outcomes for patients experiencing food insecurity.
How similar studies have performed: Other studies have shown promising results with similar interventions addressing food insecurity and diabetes management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Joseph, MD, MPH — Ohio State University
- Study coordinator: Luiza Reopell, BS
- Email: luiza.reopell@osumc.edu
- Phone: 614-653-8213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.