Diabete Type 2Phase 3VOUCH4DIABETESNCT05776420
Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes
A Phase 3 study testing Food voucher in people with Diabete Type 2, run by Unity Health Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Food voucher
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteCanada
- Study dates
- 21 Mar 2023to 1 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemoglobin A1c 6.0 to 11.0
- report food insecurity or financial insecurity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St Michael's Hospital Academic Family Health Team
Toronto
Nav Persaud, MD, nav.persaud@utoronto.ca
About this study
Official title: 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.
- Conditions
- Diabete Type 2
- Being tested
- Food voucher
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food voucherBehavioural
A voucher of that can be redeemed for food at grocery stores.
| Study group | Role | What they receive |
|---|---|---|
| Food voucher | Experimental | $65 monthly voucher for healthy foods (phase 1) Receives: Behavioral: Food voucher |
| Control | No intervention | Not described |
| Large voucher | Experimental | $160 monthly voucher for healthy foods (phase 2) Receives: Behavioral: Food voucher |
| Small voucher | Active comparator | $40 monthly voucher for healthy foods (phase 2) Receives: Behavioral: Food voucher |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Change in hemoglobin A1c
Measured: 6 months
Secondary outcomes (6)
General health ("In general, how would you rate your health today?")
Self-reported health. Potential responses are: very good, good, moderate, bad, very bad and decline to respond.
Measured: 6 months
Financial security ("Do you have trouble making ends meet at the end of the month?")
Self-reported financial security
Measured: 6 months
Food insecurity measured by 6 questions from Household Food Security Survey
Self-reported food insecurity
Measured: 6 months
Fruit and vegetable consumption
Self-reported fruit and vegetable consumption
Measured: 6 months
Health care utilization using administrative data
Includes hospitalizations, outpatient visits and primary care visits
Measured: 6 months
Carotenoid level
Serum caortenoid level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start21 Mar 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776420
- Sponsor's protocol ID
- 21-112
- Acronym
- VOUCH4DIABETES
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified individual participant data
Publications
Ul Haq MZ, Sinha L, Nwebube C, Buadu A, Sabir A, Persaud N. Experiences of people with diabetes receiving a voucher for healthy foods: a qualitative study. BMC Public Health. 2026 Feb 10;26(1):892. doi: 10.1186/s12889-026-26436-y.
PubMed 41664067Persaud N, Ul Haq MZ, Buadu A, Sabir A, Sinha L, Thorpe KE, Xu K, Hwang SW, Pinto AD, Gucciardi E. Voucher for Healthy Foods and Diabetes Control: A Randomized Clinical Trial. JAMA Intern Med. 2025 Dec 1;185(12):1434-1441. doi: 10.1001/jamainternmed.2025.5420.
PubMed 41114992
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05776420
- Acronym / sponsor ID
- VOUCH4DIABETES / 21-112
- Conditions
- Diabete Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Food voucher | Experimental | Behavioral: Food voucher$65 monthly voucher for healthy foods (phase 1) |
| Control | No intervention | – |
| Large voucher | Experimental | Behavioral: Food voucher$160 monthly voucher for healthy foods (phase 2) |
| Small voucher | Active comparator | Behavioral: Food voucher$40 monthly voucher for healthy foods (phase 2) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hemoglobin A1c 6.0 to 11.0
- report food insecurity or financial insecurity
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food voucherA voucher of that can be redeemed for food at grocery stores. | Behavioural | Food voucher, Large voucher, Small voucher |
Primary outcome
Hemoglobin A1c
Time frame: 6 months
Change in hemoglobin A1c
6 secondary outcomes
General health ("In general, how would you rate your health today?")
Time frame: 6 months
Financial security ("Do you have trouble making ends meet at the end of the month?")
Time frame: 6 months
Food insecurity measured by 6 questions from Household Food Security Survey
Time frame: 6 months
Fruit and vegetable consumption
Time frame: 6 months
Health care utilization using administrative data
Time frame: 6 months
Carotenoid level
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Derived from this study: PubMed 41664067Ul Haq MZ, Sinha L, Nwebube C, Buadu A, Sabir A, Persaud N. Experiences of people with diabetes receiving a voucher for healthy foods: a qualitative study. BMC Public Health. 2026 Feb 10;26(1):892. doi: 10.1186/s12889-026-26436-y.
- Derived from this study: PubMed 41114992Persaud N, Ul Haq MZ, Buadu A, Sabir A, Sinha L, Thorpe KE, Xu K, Hwang SW, Pinto AD, Gucciardi E. Voucher for Healthy Foods and Diabetes Control: A Randomized Clinical Trial. JAMA Intern Med. 2025 Dec 1;185(12):1434-1441. doi: 10.1001/jamainternmed.2025.5420.
- Individual participant dataSharing planned: Yes. We plan to share de-identified individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Food voucher in people with Diabete Type 2, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nav Persaud (416-864-6060, nav.persaud@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05776420, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.