Healthy Food Vouchers for Type 2 Diabetes

(VOUCH4DIABETES Trial)

Overseen By Nav Persaud

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Unity Health Toronto

Disqualifiers: Life expectancy < 6 months, multiple food allergies, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether food vouchers for healthy groceries can help people with type 2 diabetes lower their blood sugar levels. It focuses on individuals living on a low income who may struggle to afford nutritious food. Participants will be divided into two groups: one will receive food vouchers, and the other will not. Those with type 2 diabetes or high blood sugar who often worry about affording food might be a good fit for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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 treatment is likely to be safe?

Research has shown that using food vouchers as a treatment is generally safe. In one study with 390 adults, distributing healthy food vouchers did not negatively affect diabetes control. Another large study examined produce prescription programs in 22 locations across the U.S. and found them safe. These programs often improve diet and health without causing significant issues. Additionally, programs prescribing healthy foods have demonstrated positive effects on diet and diabetes without major safety concerns.

Since this is a Phase 3 trial, researchers have already tested the food voucher treatment in smaller groups for safety. Phase 3 trials focus on confirming the treatment's effectiveness while continuing to monitor its safety. This suggests the treatment is likely well-tolerated by most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 2 diabetes?

Researchers are excited about the use of healthy food vouchers for managing Type 2 diabetes because it offers a unique approach compared to traditional treatments like medications and insulin therapy. Unlike these standard options, which focus on regulating blood sugar levels chemically, food vouchers aim to improve dietary habits by making healthy foods more accessible. This method could potentially address the root cause of diabetes by encouraging long-term lifestyle changes, which may lead to better overall health outcomes. Additionally, this approach could reduce the reliance on medication, offering a more sustainable and holistic way to manage the condition.

What evidence suggests that this food voucher might be an effective treatment for type 2 diabetes?

Research shows that programs offering healthy food vouchers can help people eat better and manage diabetes more effectively. In this trial, participants in the experimental arm will receive food vouchers. Some studies have found that these programs improve heart and metabolic health by encouraging more fruit and vegetable consumption. This can lead to better control of blood sugar, which is important for people with type 2 diabetes. In some cases, these programs have even reduced the need for diabetes medications. While not all studies agree on the benefits, many report positive effects on diet and health. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for low-income individuals with type 2 diabetes or prediabetes who struggle to afford food and have a Hemoglobin A1c level between 6.0 to 11.0. It's not open to those living with another participant, with severe food allergies, on total parenteral nutrition, a life expectancy under six months, or certain blood conditions.

Inclusion Criteria

You have trouble getting enough food or money to support yourself.

Your Hemoglobin A1c level is between 6.0 and 11.0.

Exclusion Criteria

I need nutrition through an IV.

Your Hemoglobin A1c level is higher than 11.

Live with a current study participant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a voucher for healthy foods to assess its impact on blood sugar levels

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Food voucher

Trial Overview The study tests if giving out vouchers for healthy foods can lower blood sugar levels in people with type 2 diabetes or prediabetes. Participants are randomly chosen to receive these vouchers and their effects on blood glucose control are measured.

How Is the Trial Designed?

Group I: Food voucher Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Food voucher is already approved in United States for the following indications:

Approved in United States as Healthy Food Voucher for:

• Type 2 Diabetes Management
• Prediabetes Management

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Published Research Related to This Trial

A study involving 671 low-income adults showed that providing $20 per month in fruit and vegetable vouchers for 6 months led to an overall increase in fruit and vegetable intake by 0.22 cup-equivalents per day, with a significant increase observed in Los Angeles (0.64 cup-equivalents) compared to San Francisco (0.10 cup-equivalents).

The findings suggest that fruit and vegetable vouchers are particularly beneficial for lower-income populations, indicating that flat-rate benefits may be more effective than income-scaled ones in improving nutritional intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Fruit and Vegetable Intake Among Urban Low-Income US Adults Receiving a Produce Voucher in 2 Cities. Basu, S., Akers, M., Berkowitz, SA., et al.[2022]

The Fruit and Vegetable Prescription (FVRx) program significantly increased the consumption of dark green vegetables among participants compared to those in the Ad hoc Nutrition Education and Control groups, indicating its effectiveness in promoting healthier eating habits.

Participants in the FVRx program also showed improved food purchasing practices and financial management, suggesting that combining nutrition education with produce prescriptions can enhance food security and resource management for low-income adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. Slagel, N., Newman, T., Sanville, L., et al.[2022]

The Fruit and Vegetable Prescription Program (FVPP) in Michigan aims to improve children's diet, food security, and weight status by providing $15 prescriptions for fresh produce at pediatric clinic visits, with a total of 700 caregiver-child pairs enrolled for a two-year study.

The study will compare the effects of varying levels of exposure to the FVPP among children aged 8-16, assessing changes in their dietary habits and health outcomes, which will help determine the program's effectiveness and the necessary duration of exposure for significant impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. Saxe-Custack, A., Todem, D., Anthony, JC., et al.[2022]

Food is Medicine interventions significantly increase fruit and vegetable intake and lead to clinically meaningful reductions in glycated hemoglobin (A1C) levels among low-income or food-insecure individuals with diabetes, as shown in a meta-analysis of 5 randomized controlled trials involving 843 participants.

Despite the positive outcomes, half of the included studies had a high risk of bias, indicating a need for more rigorous randomized controlled trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Food is Medicine Interventions on Diabetes-related Health Outcomes Among Low-income and Food-insecure Individuals: A Systematic Review and Meta-analysis. Gao, Y., Yang, A., Zurbau, A., et al.[2023]

A systematic review of 10 studies on food provision programs for patients with type 2 diabetes or prediabetes showed that those including nutrition education consistently reduced HbA1c levels, indicating improved diabetes management.

Programs varied widely in their design and implementation, but those that incorporated nutrition education—covering topics like general nutrition and fruit/vegetable consumption—tended to yield better dietary quality and health outcomes compared to those without such education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. Schier, HE., Chetty, KS., Garrity, K., et al.[2023]

Food as Medicine interventions in food retail settings can effectively improve health outcomes and reduce healthcare costs, particularly when combining incentive programs, personalized nutrition education, and path-to-purchase marketing.

A total of 186 papers and 25 systematic reviews were analyzed, highlighting the importance of registered dietitian nutritionists in developing these interventions to help consumers manage chronic diseases and improve their nutritional choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retail Nutrition Programs and Outcomes: An Evidence Analysis Center Scoping Review. Yoder, AD., Proaño, GV., Handu, D.[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]

Community-based fruit and vegetable prescription programs, primarily targeting low-income, non-white females, have shown significant improvements in diet quality (94% of studies), health outcomes (83%), and food security (82%), indicating their effectiveness in promoting healthier eating habits.

Despite the positive outcomes, the considerable variation in study design and measurement techniques makes it difficult to compare the effectiveness of different program methodologies, highlighting the need for more standardized and well-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based fruit and vegetable prescription programs: a scoping review. Greatorex Brooks, E., McInerney, M.[2023]

The 'Prevention Produce' program, which combined fruit and vegetable prescriptions with a month-long educational curriculum, successfully increased fruit and vegetable consumption among nine families at risk of chronic disease and food insecurity.

Participants reported a greater understanding of the health benefits of produce, and the mentorship aspect of the program was positively received by both families and medical students, highlighting its potential as a model for integrating preventive health strategies in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. Forbes, JM., Forbes, CR., Lehman, E., 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 clinic-based intervention that included food insecurity screening and nutrition education led to a significant decrease in HbA1c levels among patients with diabetes, indicating improved glycemic control.

Food secure participants showed greater improvements in HbA1c compared to food insecure participants, suggesting that additional support may be needed for those facing food insecurity to achieve similar health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foods for Health: An Integrated Social Medical Approach to Food Insecurity Among Patients With Diabetes. Blitstein, JL., Lazar, D., Gregory, K., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12538504/

Voucher for Healthy Foods and Diabetes Control In this randomized clinical trial of 390 adults, a monthly voucher that allowed access to healthy foods did not improve diabetes control but did ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/10/1783/163117/Health-and-Economic-Impact-and-Cost-effectiveness

Health and Economic Impact and Cost-effectiveness of ... Produce prescription (PRx) programs have been shown to result in improved dietary quality, diabetes control, and cardiometabolic outcomes.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009520

Impact of Produce Prescriptions on Diet, Food Security ... Produce prescriptions may improve cardiometabolic health by increasing fruit and vegetable (F&V) consumption and food insecurity.

4. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/12/2/e050006.full.pdf

Healthy food prescription incentive programme for adults ... Intermediate clinical outcomes: Blood lipids; blood pressure; BMI; waist circumference; need for antihy- perglycaemic medication/insulin. d.

5. sciencedirect.com sciencedirect.com/science/article/pii/S216183132200480X

Healthy Food Prescription Programs and their Impact on ... Two-thirds of the individual studies, including 1 of the randomized trials, reported a positive effect on dietary outcomes over this time frame. In conclusion, ...

6. centerfornutrition.org centerfornutrition.org/fim

Food Is Medicine (FIM) Food is Medicine (FIM) programs integrate with the health care system to provide healthy food to prevent, manage or treat specific health conditions.