Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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 |
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