Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes
ConditionDiabete Type 2
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorUnity Health Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
hemoglobin A1c 6.0 to 11.0
report food insecurity or financial insecurity
Disqualifiers
live with a current study participant
life expectancy < 6 months
multiple life-threatening allergies to common foods
require total parenteral nutrion
Trial design
Design model
Parallel
Treatments tested in this trial
Food voucher
BehavioralA voucher of that can be redeemed for food at grocery stores.
Treatment groups
390 Participants
are divided into 4 treatment groupsGroup A: Food voucherExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Group C: Large voucherExperimental treatment 1 intervention
Group D: Small voucherActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hemoglobin A1c
Change in hemoglobin A1c
Time frame
6 monthsSecondary outcomes
1
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.
Time frame
6 months2
Financial security ("Do you have trouble making ends meet at the end of the month?")
Self-reported financial security
Time frame
6 months3
Food insecurity measured by 6 questions from Household Food Security Survey
Self-reported food insecurity
Time frame
6 months4
Fruit and vegetable consumption
Self-reported fruit and vegetable consumption
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov