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

Diabete Type 2 Clinical Trial

— VOUCH4DIABETES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776420
• Other study ID #: 21-112
• Status: Recruiting
• Phase: Phase 3
• Start date: March 21, 2023
• Est. completion date: December 2026

Study information

• Verified date: May 2023
• Source: Unity Health Toronto
• Contact: Nav Persaud
• Phone: 416-864-6060
• Email: nav.persaud[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Prediabetic State

Intervention

Behavioral:
• Food voucher
A voucher of $65 (or $85 for people in larger households) that can be redeemed for food at grocery stores.

Locations

Country	Name	City	State
Canada	St Michael's Hospital Academic Family Health Team	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Change in hemoglobin A1c	6 months
Secondary	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.	6 months
Secondary	Financial security ("Do you have trouble making ends meet at the end of the month?")	Self-reported financial security	6 months
Secondary	Food insecurity measured by 6 questions from Household Food Security Survey	Self-reported food insecurity	6 months
Secondary	Fruit and vegetable consumption	Self-reported fruit and vegetable consumption	6 months
Secondary	Health care utilization using administrative data	Includes hospitalizations, outpatient visits and primary care visits	6 months
Secondary	Carotenoid level	Serum caortenoid level	6 months