Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes
VOUCH4DIABETES
1 other identifier
interventional
390
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2023
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
March 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
February 10, 2026
February 1, 2025
4 years
February 3, 2023
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
Change in hemoglobin A1c
6 months
Secondary Outcomes (6)
General health ("In general, how would you rate your health today?")
6 months
Financial security ("Do you have trouble making ends meet at the end of the month?")
6 months
Food insecurity measured by 6 questions from Household Food Security Survey
6 months
Fruit and vegetable consumption
6 months
Health care utilization using administrative data
6 months
- +1 more secondary outcomes
Study Arms (4)
Food voucher
EXPERIMENTAL$65 monthly voucher for healthy foods (phase 1)
Control
NO INTERVENTIONLarge voucher
EXPERIMENTAL$160 monthly voucher for healthy foods (phase 2)
Small voucher
ACTIVE COMPARATOR$40 monthly voucher for healthy foods (phase 2)
Interventions
A voucher of that can be redeemed for food at grocery stores.
Eligibility Criteria
You may qualify if:
- hemoglobin A1c 6.0 to 11.0
- report food insecurity or financial insecurity
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Michael's Hospital Academic Family Health Team
Toronto, Canada
Related Publications (1)
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 Dec 1;185(12):1434-1441. doi: 10.1001/jamainternmed.2025.5420.
PMID: 41114992DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2023
First Posted
March 20, 2023
Study Start
March 21, 2023
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
February 10, 2026
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
We plan to share de-identified individual participant data