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

390 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized controlled trial (RCT) will determine if access to a voucher for healthy foods reduces blood sugar levels among people living on a low income who have type 2 diabetes or elevated blood sugar.

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 Healthy Food Vouchers for Type 2 Diabetes?

Research shows that programs like Fruit and Vegetable Prescription (FVRx) programs, which are similar to Healthy Food Vouchers, can improve fruit and vegetable consumption, nutrition knowledge, and food purchasing practices among low-income adults. These programs have been shown to help people eat more healthily and manage their food resources better, which can be beneficial for managing diabetes. ^{1 2 3 4 5}

Is the Healthy Food Voucher program safe for humans?

Research on programs like Healthy Food Vouchers, which provide financial incentives for fruits and vegetables, shows they are generally safe and can improve diet quality and health outcomes without any reported safety concerns. ^{1 5 6 7 8}

How is the Healthy Food Voucher treatment different from other treatments for type 2 diabetes?

The Healthy Food Voucher treatment is unique because it focuses on improving access to fruits and vegetables for people with type 2 diabetes, especially those who are food-insecure. Unlike traditional medications, this approach aims to enhance nutritional quality and support long-term health by addressing food access and dietary habits. ^{2 7 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 (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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. Canada 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. [2023]

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

Retail Nutrition Programs and Outcomes: An Evidence Analysis Center Scoping Review. [2021]

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

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. [2022]

5. 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]

6. England 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. [2022]

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

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Community-based fruit and vegetable prescription programs: a scoping review. [2023]

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

Comparison of Fruit and Vegetable Intake Among Urban Low-Income US Adults Receiving a Produce Voucher in 2 Cities. [2022]

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

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

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

Foods for Health: An Integrated Social Medical Approach to Food Insecurity Among Patients With Diabetes. [2022]