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

Phase 3

Recruiting

• Conditions: Diabete Type 2
• Interventions: Behavioral: Food voucher

• Registration Number: NCT05776420
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-20
• Study Start: 2023-03-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 390

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food voucher	Food voucher	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	6 months	Change in hemoglobin A1c

Secondary Outcome Measures

Name	Time	Method
Health care utilization using administrative data	6 months	Includes hospitalizations, outpatient visits and primary care visits
General health ("In general, how would you rate your health today?")	6 months	Self-reported health. Potential responses are: very good, good, moderate, bad, very bad and decline to respond.
Financial security ("Do you have trouble making ends meet at the end of the month?")	6 months	Self-reported financial security
Carotenoid level	6 months	Serum caortenoid level
Food insecurity measured by 6 questions from Household Food Security Survey	6 months	Self-reported food insecurity
Fruit and vegetable consumption	6 months	Self-reported fruit and vegetable consumption

Trial Locations

Locations (1)

St Michael's Hospital Academic Family Health Team; 🇨🇦 Toronto, Canada