Education and Produce Provision for Diabetes

Overseen By Joshua J Joseph, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Unwilling to release information

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

568 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how fresh produce delivery, diabetes education, and community support can help manage blood sugar levels in people with type 2 diabetes who face food insecurity. Participants will be divided into groups to receive a combination of fresh produce, diabetes management classes, and personalized support from community health workers. The trial includes the Mid-Ohio Food Farmacy program, which provides access to fresh produce and education. It suits individuals with type 2 diabetes, a hemoglobin A1c level of 7.5% or higher, and difficulty accessing enough food regularly. As an unphased trial, this study offers a unique opportunity to explore innovative approaches to diabetes management and improve access to essential resources.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this trial are generally safe and well-tolerated. The Mid-Ohio Food Farmacy program has demonstrated positive health effects without major safety concerns. Specifically, a study found that participants experienced health improvements, making it a safe choice for those with diabetes and food insecurity.

For the Cooking for Diabetes part of the study, results suggest it helps improve diet and self-care. This program is practical and effective, with no reported safety issues.

The Health Impact Ohio Pathways Hub employs community health workers to address social needs, supporting participants without known safety problems.

Overall, the trial treatments focus on providing food, education, and community support. These are non-invasive and aim to improve health without adding new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they incorporate innovative approaches to managing diabetes beyond standard medication and lifestyle advice. Unlike typical diabetes care that focuses primarily on medication and diet plans, these treatments offer a comprehensive strategy by providing fresh produce, hands-on cooking education, and addressing social determinants of health through community support. The Mid-Ohio Food Farmacy provides consistent access to fresh produce, while the addition of Cooking for Diabetes delivers practical culinary skills and diabetes management education. The Health Impact Ohio Pathways Hub further enriches these interventions by addressing non-medical, health-related social needs with the help of community health workers. This holistic approach could empower individuals with diabetes to achieve better health outcomes by integrating nutritional support, education, and personalized social care.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research shows that the Mid-Ohio Food Farmacy program, which provides access to healthy food, aids in managing type 2 diabetes. Participants in this trial may join the arm receiving only the Food Farmacy intervention. People in similar programs have experienced better health outcomes, such as improved blood sugar control.

Another trial arm combines the Food Farmacy with the Cooking for Diabetes program. Studies suggest this combination enhances dietary management and quality of life, particularly for those facing food insecurity.

Additionally, some participants will join an arm that includes the Health Impact Ohio Pathways Hub, offering community support to address social needs and potentially further improve health outcomes.

Overall, these programs aim to help people with type 2 diabetes manage their condition more effectively by providing fresh produce, education, and community support. ^{1 6 7 8 9}

Who Is on the Research Team?

Joshua Joseph, MD, MPH

Principal Investigator

Ohio State University

Daniel Walker, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for people with type 2 diabetes who also struggle to get enough food (food insecurity) and have high blood sugar levels, as shown by a hemoglobin A1c of 7.5% or more. Participants must be willing to share their information with the Mid-Ohio Food Collective.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes.

Your hemoglobin A1c level is 7.5% or higher.

You do not have enough food at home.

Exclusion Criteria

Unwilling to Attest to Release of Information to Mid-Ohio Food Collective

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in one of four study arms involving produce provision, diabetes education, and community referrals

6 months

Weekly visits for produce provision

Follow-up

Participants are monitored for changes in diabetes self-efficacy, food security, and Hemoglobin A1c levels

6 months

Visits at baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mid-Ohio Food Farmacy
• Mid-Ohio Food Farmacy + Cooking for Diabetes
• Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub
• Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub

Trial Overview The LINK trial is testing whether giving out fresh produce, teaching about cooking for diabetes, and connecting participants to community resources can help lower blood sugar levels in those facing both diabetes and food shortages.

How Is the Trial Designed?

Group I: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub Experimental Treatment 1 Intervention

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.

Group II: Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub Experimental Treatment 1 Intervention

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.

Group III: Mid-Ohio Food Farmacy + Cooking for Diabetes Experimental Treatment 1 Intervention

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.

Group IV: Mid Ohio Food Farmacy Active Control 1 Intervention

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 is already approved in United States for the following indications:

Approved in United States as Mid-Ohio Farmacy for:

• Food insecurity management
• Diabetes management

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A community project in Kentucky successfully increased fruit and vegetable intake among residents, with average servings rising from 2.71 to 2.94 for fruits and from 2.54 to 2.72 for vegetables over one year.

While moderate physical activity levels did not change, residents reported improved concern about physical activity resources, indicating that community involvement can enhance perceptions and support for obesity prevention initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Wide Efforts to Improve the Consumer Food Environment and Physical Activity Resources in Rural Kentucky. Gustafson, A., McGladrey, M., Stephenson, T., et al.[2020]

A multidisciplinary cooking program at a health center significantly improved participants' cooking self-efficacy and diet-related self-management strategies, with 44% reporting increased vegetable consumption after attending the classes.

Participants felt a strong sense of community, with 100% feeling valued in their cooking group, highlighting the program's effectiveness in fostering social connections alongside dietary education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-Sector Partnerships for Improved Cooking Skills, Dietary Behaviors, and Belonging: Findings from a Produce Prescription and Cooking Education Pilot Program at a Federally Qualified Health Center. Ylitalo, KR., Janda, KM., Clavon, R., et al.[2023]

The nutrition education program significantly increased knowledge about diabetes management among 44 participants, with a p-value of less than 0.01, indicating strong statistical significance.

While there was no significant change in eating behavior overall, participants' food records showed that their intake of protein and fat was within the recommended limits set by the American Diabetes Association, suggesting some positive dietary adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A regional diabetes nutrition education program: its effect on knowledge and eating behavior. Pedersen, AL., Lowry, KR.[2017]

The Fruit and Vegetable Prescription Program (F&VRx), combined with cooking and nutrition classes, effectively increased fruit and vegetable consumption among children in low-income rural families, with a 94% redemption rate of online produce credits over 5 months.

After the program, 60% of families continued to shop for produce online, indicating lasting positive changes in healthy shopping and cooking behaviors, despite initial barriers to accessing fresh foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of an online produce market combined with a fruit and vegetable prescription program for rural families. Burrington, CM., Hohensee, TE., Tallman, N., et al.[2020]

Culinary medicine programs, which include teaching kitchens and gardens, have shown promising preliminary outcomes in improving health metrics like weight and cardiometabolic risk factors in pediatric patients dealing with obesity.

Participation in culinary medicine workshops has increased healthcare employees' confidence and knowledge in preparing whole plant-based meals, suggesting that such programs can enhance healthy lifestyle behaviors both in patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Kitchens and Culinary Gardens as Integral Components of Healthcare Facilities Providing Whole Person Care: A Commentary. Fals, AM., Brennan, AM.[2023]

The Food Rx program, a collaborative initiative involving a university, Walgreens, and local health centers, aims to improve healthy eating among diabetes patients in underserved communities by providing food prescriptions that promote behavior change and connect patients to local resources.

Preliminary implementation results suggest that Food Rx effectively integrates community resources into healthcare settings, showing potential as a model for supporting the health of underserved patients, although it is still in the early stages of development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Rx: a community-university partnership to prescribe healthy eating on the South Side of Chicago. Goddu, AP., Roberson, TS., Raffel, KE., et al.[2018]

The nutrient-based diet guide method was found to be as easy to use as the food-group exchange lists method for menu planning in individuals with noninsulin-dependent diabetes, with 97 out of 105 participants completing the workshops and 83 attending the 6-month follow-up.

Participants using the diet guide method showed significantly greater improvements in nutrition knowledge retention compared to those using the exchange lists method, with a 24% increase in knowledge at 3 months versus 15% for the exchange group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educating patients with diabetes: comparison of nutrient-based and exchange group methods. Kendall, PA., Jansen, GR.[2015]

The Food as Medicine Program, implemented over 12 months with 20 participants, showed a slight decrease in HbA1c levels, indicating potential benefits in managing type 2 diabetes symptoms, although these changes were not statistically significant.

Participants reported improvements in diabetes self-care activities and a reduction in diabetes-related distress, suggesting that the program may enhance self-management behaviors essential for effective diabetes control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot evaluation of the Food as Medicine program for patients with type 2 diabetes. Biber, DD.[2023]

A prescription (PRx) program in rural Eastern North Carolina provided patients with type 2 diabetes weekly home deliveries of fruits and vegetables, leading to high patient satisfaction and increased consumption of produce.

The program not only improved dietary habits but also significantly enhanced glycemic control, demonstrating the effectiveness of combining food access with nutrition education and culinary resources for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of the Delivery-Based HEALED Produce Rx Program for Uninsured Patients With Diabetes in Rural Eastern North Carolina. Sastre, LR., Stroud, B., Smith, E., et al.[2023]

Recent research highlights the importance of dietary quality and meal composition in managing Type 1 Diabetes (T1D), leading to changes in how nutrition education is delivered to children and young people.

Nutrition education is evolving from just focusing on carbohydrate counting and insulin adjustments to emphasizing the impact of whole food choices on blood sugar control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Strategies in Nutrition Education to Optimize Glycemic Management for Children with Diabetes. Annan, F.[2018]

Citations

1. glenn.osu.edu glenn.osu.edu/research-and-impact/utilization-patterns-food-referral-program-findings-mid-ohio-farmacy

Utilization Patterns of a Food Referral Program Results: In total, 51% (164 of 322) of patients referred to the MOF visited a food pantry at least once. Visitors were more likely to be older, ...

2. healthpolicyohio.org healthpolicyohio.org/files/assets/farmacyphase1evalfullreport122024.pdf

Acknowledgements It is an important indicator for type 2 diabetes management. • Mid-Ohio Farmacy pantry: A Mid-Ohio Food Collective (MOFC) food pantry that.

3. cdc.gov cdc.gov/pcd/issues/2023/23_0155.htm

Geospatial Determinants of Food Pantry Access in the Mid- ... The purpose of this study is to provide a geospatial perspective of linkages and explore how neighborhood environment, walkability, and pantry proximity are ...

4. withpower.com withpower.com/trial/phase-poor-nutrition-9-2022-bd849

Education and Produce Provision for Diabetes What data supports the effectiveness of the treatment Mid-Ohio Food Farmacy and related programs for diabetes? Research on similar programs, like the Food ...

5. jabfm.org jabfm.org/content/jabfp/34/6/1174.full.pdf

Utilization Patterns of a Food Referral Program To address this gap, this study aims to describe the utilization of the Mid-Ohio Farmacy (MOF). MOF is a partnership between a regional food- bank and local ...

6. healthpolicyohio.org healthpolicyohio.org/health-policy-news/2024/10/11/ohio-food-prescription-program-leads-to-health-benefits-study-finds

Ohio food prescription program leads to health benefits ... A new study has found that an Ohio partnership between food pantries and health providers can have positive health impacts for patients ...

7. nbc4i.com nbc4i.com/feedingamerica/study-confirms-mid-ohio-farmacys-success-in-improving-patients-health/

Study confirms Mid-Ohio Farmacy's success in improving ... “What we saw was that people had substantial improvements in their health outcomes, in their chronic conditions.” The data in the study ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34772772/

Utilization Patterns of a Food Referral Program Results: In total, 51% (164 of 322) of patients referred to the MOF visited a food pantry at least once. Visitors were more likely to be older, have diabetes, ...

9. medicine.osu.edu medicine.osu.edu/news/food-is-medicine

Food is medicine: A prescription for better health outcomes A 2023 study by the Ohio Association of Foodbanks found that 65% of survey participants reported cutting the size of meals or skipping meals ...