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

NCT ID: NCT05776420

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2025-04-01

Brief Summary

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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

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Conditions

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Diabete Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Food voucher

Group Type EXPERIMENTAL

Food voucher

Intervention Type BEHAVIORAL

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Food voucher

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Michael's Hospital Academic Family Health Team

Toronto, , Canada

Site Status

Countries

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Canada

References

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Persaud N, Ul Haq MZ, Buadu A, Sabir A, Sinha L, Thorpe KE, Xu K, Hwang SW, Pinto AD, Gucciardi E. Voucher for Healthy Foods and Diabetes Control: A Randomized Clinical Trial. JAMA Intern Med. 2025 Oct 20. doi: 10.1001/jamainternmed.2025.5420. Online ahead of print.

Reference Type DERIVED
PMID: 41114992 (View on PubMed)

Other Identifiers

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21-112

Identifier Type: -

Identifier Source: org_study_id

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