Healthy Food Vouchers for Type 2 Diabetes
(VOUCH4DIABETES Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Unity Health Toronto
Disqualifiers: Life expectancy < 6 months, multiple food allergies, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
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.
12345Is 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.
15678How 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.
2791011Eligibility 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
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Food voucherExperimental Treatment1 Intervention
Group II: ControlActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
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Who Is Running the Clinical Trial?
Unity Health TorontoLead Sponsor
References
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]Food provision interventions (eg, produce/food prescriptions, food pharmacies, food voucher programs) that bridge clinic and community settings for improved nutritional health outcomes of at-risk patients have gained momentum. Little is known about the role of nutrition education and potential augmented impact on patient outcomes.
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]In this study, we aim to review the current evidence of Food is Medicine interventions on diabetes outcomes among low-income or food-insecure individuals.
Retail Nutrition Programs and Outcomes: An Evidence Analysis Center Scoping Review. [2021]As nutrition-related diseases contribute to rising health care costs, food retail settings are providing a unique opportunity for registered dietitian nutritionists (RDNs) to address the nutritional needs of consumers. Food as Medicine interventions play a role in preventing and/or managing many chronic conditions that drive health care costs. The objective of this scoping review was to identify and characterize literature examining Food as Medicine interventions within food retail settings and across consumer demographics. An electronic literature search of 8 databases identified 11,404 relevant articles. Results from the searches were screened against inclusion criteria, and intervention effectiveness was assessed for the following outcomes: improvement in health outcomes and cost-effectiveness. One-hundred and eighty-six papers and 25 systematic reviews met inclusion criteria. Five categories surfaced as single interventions: prescription programs, incentive programs, medically tailored nutrition, path-to-purchase marketing, and personalized nutrition education. Multiple combinations of intervention categories, reporting of health outcomes (nutritional quality of shopping purchases, eating habits, biometric measures), and cost-effectiveness (store sales, health care dollar savings) also emerged. The intervention categories that produced both improved health outcomes and cost-effectiveness included a combination of incentive programs, personalized nutrition education, and path-to-purchase marketing. Food as Medicine interventions in the food retail setting can aid consumers in navigating health through diet and nutrition by encompassing the following strategic focus areas: promotion of health and well-being, managing chronic disease, and improving food security. Food retailers should consider the target population and desired focus areas and should engage registered dietitian nutritionists when developing Food as Medicine interventions.
Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. [2022]Fruit and Vegetable Prescription (FVRx) Programs combine produce prescriptions and nutrition education to reduce fruit and vegetable consumption barriers and promote health among low-income patient populations. This study examined whether a multi-level FVRx intervention model with intensive education improves dietary behaviors, food security, and health outcomes over single-level interventions alone. A 6-month nonrandomized, parallel, controlled trial was conducted with one intervention, FVRx (n = 31) and two comparison groups, Ad hoc Nutrition Education (n = 13) and Control (n = 16). The FVRx group received produce prescriptions (US$1/day/household member) redeemable at a farmer's market, two SNAP-Ed programs, one financial literacy program, and monthly health screenings. The Nutrition Education (NE) group participated in one SNAP-Ed program, and the Control group received safety-net clinic care only. Surveys assessed dietary intake, food security, food purchasing practices, and financial and food resource management. Pre-post clinical biomarkers (blood lipid and hemoglobin A1c) and monthly biometrics (anthropometrics and blood pressure) were measured. Descriptive analysis and one-way analysis of variance (ANOVA) were conducted. Compared with comparison groups, FVRx participants significantly increased the frequency of consuming dark green vegetables, FVRx (0.36 ± 0.72); NE (0.14 ± 0.33); Control (-0.09 ± 0.19) cups/day (p < .05). FVRx participants significantly improved multiple healthful food purchasing practices, and the ability to afford more utilities (FVRx (33%); NE (0%); Control (10%); p < .05). Limited changes were observed in food security and clinical biomarker outcomes between groups. Combining expanded nutrition and financial literacy education with produce prescriptions improves low-income adults' financial and food resources, preference, knowledge, purchase, and consumption of locally grown vegetables over single-level interventions.
A Pilot Fruit and Vegetable Prescription (FVRx) Program Improves Local Fruit and Vegetable Consumption, Nutrition Knowledge, and Food Purchasing Practices. [2023]Fruit and Vegetable Prescription (FVRx) programs rely on diverse community and clinic partnerships to improve food security and fruit and vegetable consumption among medically underserved patient populations. Despite the growth in these programs, little is known about the feasibility or effectiveness of the unique partnerships developed to implement FVRx programs conducted in both community and free safety-net clinic settings. A 6-month nonrandomized controlled trial of an FVRx program was pilot tested with 54 Supplemental Nutrition Assistance Program (SNAP)-eligible adults with diet-related chronic conditions. The intervention combined monthly produce prescriptions for local produce at a farmers market, SNAP-Ed direct nutrition education, and health screenings for low-income adults. Process and outcome evaluations were conducted with respective samples using administrative program data (recruitment, retention, and prescription redemption) and self-administered pre- and postintervention surveys with validated measures on dietary intake, nutrition knowledge and behavior, and food purchasing practices. Descriptive statistical analyses were conducted. The FVRx program retained 77.3% of participants who spent nearly 90% of their prescription dollars. After the intervention, the FVRx group reported significantly increased total intake of fruits and vegetables, knowledge of fresh fruit and vegetable preparation, purchase of fresh fruits and vegetables from a farmers market, and significantly altered food purchasing practices compared with the control group. Community-based nutrition education organizations enhance the feasibility and effectiveness of community and clinic-based FVRx programs for improving low-income adults' ability to enhance food and nutrition-related behaviors.
Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. [2022]Although nutrients in fruits and vegetables are necessary for proper development and disease prevention, most US children consume fewer servings than recommended. Prescriptions for fruits and vegetables, written by physicians to exchange for fresh produce, address access and affordability challenges while emphasizing the vital role of diet in health promotion and disease prevention. Michigan's first fruit and vegetable prescription program (FVPP) exclusively for children was introduced in 2016 at one large pediatric clinic in Flint and expanded to a second clinic in 2018. The program provides one $15 prescription for fresh produce to all pediatric patients at every office visit. Prescriptions are redeemable at a year-round farmers' market or a local mobile market. The current study will assess the impact of this FVPP on diet, food security, and weight status of youth.
"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. [2020]Fruit and vegetable prescription (FVRx) programs provide increased access to produce to food-insecure, at-risk populations, yet many lack the educational and social components to support long-term disease prevention.
Community-based fruit and vegetable prescription programs: a scoping review. [2023]Identify and categorise different models of community-based fruit and vegetable prescription programs, to determine variation in terms of methodology, target population characteristics, and outcomes measured. Applying the scoping review methodology, ten electronic databases were utilised to identify community-based fruit and vegetable incentive programs. Results were evaluated by two independent reviewers, using Covidence software. All full-text reviews were completed and documented using the PRISMA-ScR guidelines. Search results were stored and reviewed within the Covidence software. Thirty full-text articles were utilised from the 40 206 identified in the search. Target populations were predominantly female, non-white, and low-income. Considerable heterogeneity was found in both study design and quality. Fruit and vegetable vouchers were utilised in 63 % (n 19) of the studies. Prescriptions were primarily provided by community health centres (47 %; n 14) or NGOs (307 %; n 9) and could be redeemed at farmers' markets (40 %; n 12) or grocery stores (27 %; n 8). When measured, diet quality significantly improved in 94 % (n 16), health outcomes significantly improved in 83 % (n 10), and food security status improved in 82 % (n 10) of studies. Providing financial incentives to offset the cost of fresh fruits and vegetables can increase consumption, improve health outcomes, and improve food security status. The majority of studies showed significant improvements in at least one outcome, demonstrating the effectiveness of community-based fruit and vegetable prescription programs. However, the diversity of measurement techniques and heterogeneity of design, dosage, and duration impeded meaningful comparisons. Further well-designed studies are warranted to compare the magnitude of effects among different program methodologies.
Comparison of Fruit and Vegetable Intake Among Urban Low-Income US Adults Receiving a Produce Voucher in 2 Cities. [2022]Fruit and vegetable vouchers have been implemented by cities and counties across the US to increase fruit and vegetable intake and thereby improve overall nutritional quality.
Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. [2020]Type 2 diabetes mellitus is an immense burden to the health of our population and to our current health care system, and the weight of this burden is only projected to multiply in coming years. A nutritious diet is an indispensable aspect of diabetes treatment, and the lack of access to food engenders poor disease-state control, which correlates with increased health care utilization. Interventions aimed at improving access to food through medically tailored meals (MTMs) have demonstrated effectiveness in improving the health of food-insecure type 2 diabetic patients and reducing health care costs. Further studies are necessary to increase the external validity of existing positive research on medically tailored meals in food-insecure diabetic patients and to provide evidence to support potential policy changes under which the costs of medically tailored meals for diabetics might be covered by insurers.
Foods for Health: An Integrated Social Medical Approach to Food Insecurity Among Patients With Diabetes. [2022]Examine a clinic-based approach to improve food security and glycemic control among patients with diabetes.