Diabete Type 2
Conditions
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.
Interventions
BEHAVIORALFood voucher
A voucher of that can be redeemed for food at grocery stores.
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 6 months | Change in hemoglobin A1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Health care utilization using administrative data | 6 months | Includes hospitalizations, outpatient visits and primary care visits |
| Carotenoid level | 6 months | Serum caortenoid level |
Countries
Canada
Contacts
CONTACTNav Persaud
Outcome results
None listed