Healthy Food Delivery for Type 2 Diabetes Management

Recruiting at 4 trial locations

Overseen By Kelsey R Bounds, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Terminal illness, Severe mental illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

415 Participants Needed

Trial Summary

What is the purpose of this trial?

Our long-term goal is to transform rural residents' management of T2DM. This study's objective is to determine the effectiveness of an intervention that is scalable and sustainable and promotes patient adherence by mitigating rural food insecure participants' difficulties associated with completing existing interventions. Our specific aims are: 1. Compare the effectiveness of the Healthy Food Delivery Intervention (HFDI) plus standard care and standard care alone to improve diabetes-related outcomes among rural food insecure patients with T2DM. Hypothesis: Compared with standard care alone, patients receiving the HFDI plus standard care will demonstrate improved: H1 glycemic control as measured by HbA1c; H2 cardio-metabolic risk factors: blood pressure, fasting glucose, fasting lipids, and BMI; H3 self-management: self-efficacy, adherence to self-management behaviors, and medication adherence; H4 patient-centered outcomes: diabetes-related distress, diabetes-related quality of life, and diabetes-related complications. 2. Compare the effectiveness of the HFDI plus standard care and standard care alone to improve diet quality among rural food insecure patients with T2DM. Hypothesis: Compared with standard care alone, patients receiving the HFDI plus standard care will demonstrate improved: H1 Healthy Eating Index 2015 (HEI-2015) scores; H2 fruit and vegetable consumption. 3. Compare cost-effectiveness to understand HFDI plus standard care costs in relationship to outcomes in relation to standard care alone. Hypothesis: The HFDI will be cost-effective based on traditional cost per additional quality-adjusted life year gained.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the study focuses on adding a healthy food delivery intervention to standard care.

What data supports the effectiveness of the Healthy Food Delivery Intervention treatment for managing Type 2 Diabetes?

Research shows that delivering healthy food to people with Type 2 Diabetes can improve their food security and overall health status. Similar programs, like food prescription initiatives, have led to increased fruit and vegetable consumption and better dietary habits, which are important for managing diabetes. ^{1 2 3 4 5}

Is the Healthy Food Delivery for Type 2 Diabetes Management safe for humans?

The studies on similar programs, like medically-tailored meal interventions and food prescription programs, show that they are generally safe and well-received by participants, with improvements in food security and health status reported. ^{1 3 4 6 7}

How does the Healthy Food Delivery Intervention treatment differ from other treatments for type 2 diabetes?

The Healthy Food Delivery Intervention is unique because it involves delivering ethnically tailored, nutritious food directly to the homes of people with type 2 diabetes who are experiencing food insecurity. Unlike traditional treatments that focus on medication, this approach aims to improve health by addressing food access and dietary needs, which can enhance overall health and reduce health disparities. ^{1 6 8 9 10}

Research Team

Christopher R Long, PhD

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for rural residents 18 or older with Type 2 Diabetes who report food insecurity and speak English or Spanish. They must have an HbA1c level of at least 6.5, indicating diabetes. It's not for pregnant individuals, those with terminal illness, severe mental illness, impaired vision/hearing, eating disorders, or plans to move away soon.

Inclusion Criteria

My diabetes is confirmed with an HbA1c level of 6.5 or higher.

Tell us if you don't have enough food to eat.

You have difficulty getting enough food to eat.

Exclusion Criteria

I am able to follow the study's requirements without major health or personal obstacles.

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Healthy Food Delivery Intervention (HFDI) plus standard care or standard care alone

18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Healthy Food Delivery Intervention

Trial Overview The study tests if delivering healthy food to patients plus standard care improves diabetes management better than standard care alone in rural areas. It measures blood sugar control (HbA1c), heart risk factors (blood pressure/lipids/BMI), self-care behaviors/medication adherence and quality of life.

Participant Groups

Group I: Healthy Food Delivery Intervention Experimental Treatment 1 Intervention

9000 calorie / week food box

Group II: Standard Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Findings from Research

A pilot study involving adults with type 2 diabetes and food insecurity showed that a collaboration between a food bank and a health system to deliver tailored food was feasible and led to high participant satisfaction over 24 weeks.

While the intervention improved food security and overall health status, it did not significantly change HbA1c levels or healthcare utilization, suggesting that while food support is beneficial, additional strategies may be needed to improve glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Collaborative Pilot to Support Patients With Diabetes Through Tailored Food Box Home Delivery. Kempainen, S., Cutts, DB., Robinson-O'Brien, R., et al.[2023]

The A Prescription for Healthy Living (APHL) culinary medicine curriculum led to a significant reduction in HbA1c levels among patients with diabetes, indicating improved blood sugar control, with a mean difference of -0.96% (p = 0.028).

Participants in the APHL program reported increased fruit and vegetable consumption, greater confidence in cooking healthy meals, and more frequent cooking from scratch, suggesting positive changes in dietary behaviors and self-efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program. Sharma, SV., McWhorter, JW., Chow, J., et al.[2022]

A pilot program prescribing fresh fruits and vegetables to 60 food-insecure patients led to significant improvements in food security and increased consumption of fruits and certain vegetables, indicating a positive impact on dietary habits.

Participants reported enhanced availability and accessibility of healthy foods, suggesting that fresh food prescription programs can effectively support healthier eating and improve food environments for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was eating more fruits and veggies than I have in years": a mixed methods evaluation of a fresh food prescription intervention. Heasley, C., Clayton, B., Muileboom, J., et al.[2021]

The Fruit and Vegetable Prescription (FVRx) program, tested with 54 SNAP-eligible adults over 6 months, successfully retained 77.3% of participants, who utilized nearly 90% of their produce prescriptions, indicating strong engagement and feasibility.

Participants in the FVRx program significantly increased their intake of fruits and vegetables, improved their knowledge of food preparation, and changed their food purchasing habits compared to a control group, demonstrating the program's effectiveness in enhancing nutrition-related behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Fruit and Vegetable Prescription (FVRx) Program Improves Local Fruit and Vegetable Consumption, Nutrition Knowledge, and Food Purchasing Practices. Slagel, N., Newman, T., Sanville, L., et al.[2023]

A pilot food prescription program called Fresh Start Food Rx provided biweekly fresh fruits and vegetables and dietary education to four uninsured patients in South Miami, showing potential to improve dietary behaviors and attitudes toward healthy eating.

Participants reported an increase in the number of days they consumed fruits per week and a rise in vegetable servings, indicating that access to healthy foods and education can positively influence eating habits and perceptions about nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. Oliveira, JB., To, L., De La Cruz, Y., et al.[2021]

Participants in a medically-tailored meal program for individuals with type 2 diabetes reported high satisfaction and noted improvements in their quality of life and diabetes management, highlighting the program's effectiveness.

The study emphasized the importance of culturally appropriate meals and suggested that combining these meal programs with diabetes education could enhance their impact on managing diabetes and reducing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. Berkowitz, SA., Shahid, NN., Terranova, J., et al.[2020]

Medically tailored meals (MTMs) have been shown to effectively improve health outcomes for food-insecure patients with type 2 diabetes, highlighting the importance of nutrition in diabetes management.

Improving access to nutritious food through MTMs not only benefits patient health but also has the potential to reduce overall healthcare costs, suggesting a need for further research to support insurance coverage for these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. Rabaut, LJ.[2020]

A 3-month produce prescription program for 303 predominantly Hispanic/Latino adults with or at risk of type 2 diabetes led to significant reductions in weight, waist circumference, and systolic blood pressure, indicating improved cardio-metabolic health.

Participants with higher baseline HbA1c levels experienced a notable decrease in HbA1c, alongside improvements in food security and mental health measures, suggesting that access to fresh produce can positively impact both physical and psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal changes in bio-behavioral and glycemic outcomes following a produce prescription program among predominantly Hispanic/Latino adults with or at risk of type 2 diabetes. Sato Imuro, SE., Sabharwal, A., Conneely, C., et al.[2023]

References

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

A Collaborative Pilot to Support Patients With Diabetes Through Tailored Food Box Home Delivery. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program. [2022]

3. England pubmed.ncbi.nlm.nih.gov

"I was eating more fruits and veggies than I have in years": a mixed methods evaluation of a fresh food prescription intervention. [2021]

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

A Pilot Fruit and Vegetable Prescription (FVRx) Program Improves Local Fruit and Vegetable Consumption, Nutrition Knowledge, and Food Purchasing Practices. [2023]

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

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. [2021]

6. England pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies. [2023]

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

Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Temporal changes in bio-behavioral and glycemic outcomes following a produce prescription program among predominantly Hispanic/Latino adults with or at risk of type 2 diabetes. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Facilitators and barriers to preparing and offering whole grains to children diagnosed with prediabetes: qualitative interviews with low-income caregivers. [2021]