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NCT05776420 Clinical Trial

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
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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