Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes (VOUCH4DIABETES)

February 5, 2026 updated by: Unity Health Toronto

Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes: a Randomized Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

390

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • hemoglobin A1c 6.0 to 11.0
  • report food insecurity or financial insecurity

Exclusion Criteria:

  • live with a current study participant
  • life expectancy < 6 months
  • multiple life-threatening allergies to common foods
  • require total parenteral nutrion
  • blood dyscrasia that interferes with hemoglobin A1c interpretation
  • hemoglobin A1c >11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Food voucher
$65 monthly voucher for healthy foods (phase 1)
Behavioral: Food voucher
A voucher of that can be redeemed for food at grocery stores.
Experimental: Large voucher
$160 monthly voucher for healthy foods (phase 2)
Behavioral: Food voucher
A voucher of that can be redeemed for food at grocery stores.
Active Comparator: Small voucher
$40 monthly voucher for healthy foods (phase 2)
Behavioral: Food voucher
A voucher of that can be redeemed for food at grocery stores.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 6 months
Change in hemoglobin A1c
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General health ("In general, how would you rate your health today?")
Time Frame: 6 months
Self-reported health. Potential responses are: very good, good, moderate, bad, very bad and decline to respond.
6 months
Financial security ("Do you have trouble making ends meet at the end of the month?")
Time Frame: 6 months
Self-reported financial security
6 months
Food insecurity measured by 6 questions from Household Food Security Survey
Time Frame: 6 months
Self-reported food insecurity
6 months
Fruit and vegetable consumption
Time Frame: 6 months
Self-reported fruit and vegetable consumption
6 months
Health care utilization using administrative data
Time Frame: 6 months
Includes hospitalizations, outpatient visits and primary care visits
6 months
Carotenoid level
Time Frame: 6 months
Serum caortenoid level
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share de-identified individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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