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NCT Number: NCT05776420

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

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.

Recruiting

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Key information

Conditions

Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St Michael's Hospital Academic Family Health Team

Toronto, Canada

Location status: Recruiting

Location contact

Nav Persaud, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food voucher

Behavioral

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

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 6 months

    Change in hemoglobin A1c

Secondary outcomes

  1. 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.

  2. Financial security ("Do you have trouble making ends meet at the end of the month?")

    Time frame: 6 months

    Self-reported financial security

  3. Food insecurity measured by 6 questions from Household Food Security Survey

    Time frame: 6 months

    Self-reported food insecurity

  4. Fruit and vegetable consumption

    Time frame: 6 months

    Self-reported fruit and vegetable consumption

  5. Health care utilization using administrative data

    Time frame: 6 months

    Includes hospitalizations, outpatient visits and primary care visits

  6. Carotenoid level

    Time frame: 6 months

    Serum caortenoid level

Study contacts

Contact information is provided by the study sponsor or research team.

Nav Persaud

CONTACT

[email protected]

416-864-6060

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Acronym: VOUCH4DIABETES

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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