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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Mid-Ohio Food Farmacy and related programs for diabetes?

Research on similar programs, like the Food as Medicine and Produce Rx programs, shows that providing healthy food and nutrition education can improve diet quality and diabetes-related health outcomes, such as better blood sugar control and increased vegetable consumption. These programs also enhance participants' knowledge, motivation, and self-care behaviors, which are crucial for managing diabetes. ^{1 2 3 4 5}

Is the Education and Produce Provision for Diabetes program safe for humans?

The studies reviewed did not report any safety concerns for similar programs that provide fruits, vegetables, and nutrition education to people with diabetes. Participants generally showed improved health outcomes and satisfaction with the programs. ^{1 2 4 6 7}

How does the Mid-Ohio Food Farmacy treatment differ from other diabetes treatments?

The Mid-Ohio Food Farmacy treatment is unique because it combines access to healthy food with education and community support, aiming to improve diet quality and diabetes management through a holistic approach. This includes providing fresh produce, cooking classes, and connecting patients to local health resources, which is different from traditional diabetes treatments that often focus solely on medication and clinical care. ^{2 4 8 9 10}

What is the purpose of this trial?

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.

Research Team

Joshua Joseph, MD, MPH

Principal Investigator

Ohio State University

Daniel Walker, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2023]

3. Switzerland 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A regional diabetes nutrition education program: its effect on knowledge and eating behavior. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Community-Wide Efforts to Improve the Consumer Food Environment and Physical Activity Resources in Rural Kentucky. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A pilot study of an online produce market combined with a fruit and vegetable prescription program for rural families. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Food Rx: a community-university partnership to prescribe healthy eating on the South Side of Chicago. [2018]

9. Israel pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Educating patients with diabetes: comparison of nutrient-based and exchange group methods. [2015]