Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes (VOUCH4DIABETES)

Unity Health Toronto

Status and phase: Completed; Phase 3

Conditions: Diabete Type 2

Treatments: Behavioral: Food voucher

Study type: Interventional

Funder types: Other

Identifiers

NCT05776420

21-112

Details and patient eligibility

About

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.

Enrollment: 390 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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390 participants in 2 patient groups

Food voucher

Experimental group

Treatment:

Behavioral: Food voucher

Control

No Intervention group