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

Primary Purpose

Diabete Type 2

Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Food voucher
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabete Type 2

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St Michael's Hospital Academic Family Health TeamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Food voucher

Control

Arm Description

Outcomes

Primary Outcome Measures

Hemoglobin A1c
Change in hemoglobin A1c

Secondary Outcome Measures

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.
Financial security ("Do you have trouble making ends meet at the end of the month?")
Self-reported financial security
Food insecurity measured by 6 questions from Household Food Security Survey
Self-reported food insecurity
Fruit and vegetable consumption
Self-reported fruit and vegetable consumption
Health care utilization using administrative data
Includes hospitalizations, outpatient visits and primary care visits
Carotenoid level
Serum caortenoid level

Full Information

First Posted
February 3, 2023
Last Updated
May 15, 2023
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05776420
Brief Title
Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Food voucher
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Food voucher
Intervention Description
A voucher of $65 (or $85 for people in larger households) that can be redeemed for food at grocery stores.
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Change in hemoglobin A1c
Time Frame
6 months
Secondary Outcome Measure Information:
Title
General health ("In general, how would you rate your health today?")
Description
Self-reported health. Potential responses are: very good, good, moderate, bad, very bad and decline to respond.
Time Frame
6 months
Title
Financial security ("Do you have trouble making ends meet at the end of the month?")
Description
Self-reported financial security
Time Frame
6 months
Title
Food insecurity measured by 6 questions from Household Food Security Survey
Description
Self-reported food insecurity
Time Frame
6 months
Title
Fruit and vegetable consumption
Description
Self-reported fruit and vegetable consumption
Time Frame
6 months
Title
Health care utilization using administrative data
Description
Includes hospitalizations, outpatient visits and primary care visits
Time Frame
6 months
Title
Carotenoid level
Description
Serum caortenoid level
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nav Persaud
Phone
416-864-6060
Email
nav.persaud@utoronto.ca
Facility Information:
Facility Name
St Michael's Hospital Academic Family Health Team
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nav Persaud, MD
Email
nav.persaud@utoronto.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share de-identified individual participant data

Learn more about this trial

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

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