Healthy Food Delivery for Type 2 Diabetes Management

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether delivering healthy food boxes can help people with type 2 diabetes manage their condition more effectively. It compares two groups: one receiving healthy food deliveries along with regular care, and another receiving only regular care. The goal is to determine if food deliveries improve diabetes control, diet quality, and overall well-being. This trial may suit those living in rural areas with type 2 diabetes who struggle to access healthy food. As an unphased trial, it offers a unique opportunity to explore innovative ways to enhance health and well-being.

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 prior data suggests that the Healthy Food Delivery Intervention is safe for managing Type 2 Diabetes?

Research has shown that having healthy food delivered can safely help manage Type 2 diabetes. In studies where patients received these food boxes, no serious side effects occurred. Participants experienced better blood sugar control and felt less stress about their diabetes. This indicates that the food delivery program is not only effective but also easy to manage. Because the study focuses on providing food, the risks are much lower compared to more invasive treatments. In short, healthy food delivery is a safe option for managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Food Delivery Intervention for managing Type 2 Diabetes because it offers a unique approach compared to standard care, which often involves medications like Metformin and lifestyle advice. Unlike typical treatments that focus on medication and self-regulation, this intervention delivers a weekly 9,000-calorie food box packed with healthy options directly to participants. This direct delivery method aims to simplify healthy eating and potentially improve adherence to dietary recommendations, addressing a critical aspect of diabetes management. By making it easier for individuals to access nutritious meals, researchers hope this approach can lead to better blood sugar control and overall health outcomes.

What evidence suggests that the Healthy Food Delivery Intervention could be effective for managing Type 2 Diabetes?

Research has shown that delivering healthy food to people with type 2 diabetes can help manage blood sugar levels. In this trial, participants in the Healthy Food Delivery Intervention arm will receive a 9000 calorie/week food box. One study found that recipients of similar food deliveries had better blood sugar control. Another study suggested that these meals could improve diet quality, leading to better overall health. Early findings also indicate potential benefits for managing other diabetes-related health risks, such as blood pressure and cholesterol. Overall, healthy food delivery appears to be a practical way to help people with type 2 diabetes improve their health. ^{2 3 6 7 8}

Who Is on the Research Team?

Christopher R Long, PhD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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 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]

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]

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]

Citations

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Healthy Food Delivery for Type 2 Diabetes Management in ... The primary outcome is change in HbA1c, with secondary measures including diet quality (Healthy Eating Index-2015, calculated from one 24-hr dietary recall at ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442400065X

Healthy food delivery for type 2 diabetes management in ... This study uses a two-arm randomized controlled comparative effectiveness design to compare the effectiveness of a Healthy Food Delivery Intervention (HFDI) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2212351/

Intervention with Delivery of Diabetic Meals Improves ... This study provides evidence that intervention with delivery of diabetic meals to patients with type 2 diabetes can be equally effective for achieving glycemic ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04876053

Home Food Delivery for Diabetes Management in Patients ... This study's objective is to determine the effectiveness of an intervention that is scalable and sustainable and promotes patient adherence by mitigating rural ...

5. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S14/157553/1-Improving-Care-and-Promoting-Health-in

1. Improving Care and Promoting Health in Populations The impact of health literacy interventions on glycemic control and self-management outcomes among type 2 diabetes mellitus: a systematic review.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38458560/

Healthy food delivery for type 2 diabetes management in rural ... Data are collected at pre-intervention, 3-months (post-intervention), 9-months, and 15-months. The primary outcome is change in HbA1c, with ...

7. cdc.gov cdc.gov/pcd/issues/2020/19_0210.htm

Food Bank–Based Diabetes Prevention Intervention to ... Primary outcomes assessed were food security status, dietary intake, health-related behaviors, and body mass index (BMI). Information on ...

8. diabetesjournals.org diabetesjournals.org/diabetes/article-abstract/71/Supplement_1/170-OR/146111

170-OR: Outcomes of a Digital Health Coaching Program ... At 3 months, there were significant improvements in mean scores on the Diabetes Distress Score (2.76 to 2.09, p<0.001) , HbA1c (8.22 to 7.52, p< ...