Recruiting
Phase 3

Healthy Food Voucher

Sponsor:

Unity Health Toronto

Code:

NCT05776420

Conditions

Diabete Type 2

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Food voucher

Study Details

Brief 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.

Conditions

Diabete Type 2

Study ID

NCT05776420

Start date

Mar 21, 2023

Status verified date

Feb, 2025

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

390 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Food voucher

$65 monthly voucher for healthy foods (phase 1)

no intervention: Control

experimental: Large voucher

$160 monthly voucher for healthy foods (phase 2)

active comparator: Small voucher

$40 monthly voucher for healthy foods (phase 2)

Interventions

Food voucher

A voucher of that can be redeemed for food at grocery stores.

Primary outcome measure

  • Hemoglobin A1c [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Nav Persaud

416-864-6060nav.persaud@utoronto.ca

Locations

St Michael's Hospital Academic Family Health Team

Recruiting

Toronto, Canada

Contacts

Nav Persaud, MD

nav.persaud@utoronto.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

Feb 10, 2026

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-02-10.