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Recruiting NCT05776420

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

Phase III Interventional Diabete Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Food voucher.
Who it may be relevant to
Registry conditions: Diabete Type 2. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Hemoglobin A1c [Time frame: 6 months]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • St Michael's Hospital Academic Family Health Team — Toronto

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. PMID 41664067
  • Persaud 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. PMID 41114992

Identifiers

NCT: NCT05776420 · 21-112

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗