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Behavioural Intervention
Produce Prescription for Type 2 Diabetes (PPT2D Trial)
N/A
Waitlist Available
Led By Carmen Byker Shanks, PhD
Research Sponsored by Gretchen Swanson Center for Nutrition
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with Type 2 diabetes
≥ 18 years of age
Must not have
Plans to move away during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1-2, 7-8
Awards & highlights
Summary
This trial aims to measure the impact of Produce Prescription Projects on type 2 diabetes-related outcomes in those with low-income. It will assess primary outcomes like Fruit and Vegetable Intake and Hemoglobin A1c, as well as food security & healthcare utilization.
Who is the study for?
This trial is for adults over 18 with Type 2 diabetes who are low-income, eligible for Medicaid or SNAP benefits, and have food insecurity. It's not open to those who are pregnant, nursing, or planning to move during the study.
What is being tested?
The trial tests a Produce Prescription program that helps low-income individuals with Type 2 diabetes buy fruits and vegetables. The impact on blood sugar control (HbA1c), diet quality, food security, and healthcare costs will be studied.
What are the potential side effects?
Since this intervention involves dietary changes by increasing fruit and vegetable intake through financial incentives rather than medication or medical procedures, no direct side effects are expected from the Produce Prescription itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Type 2 diabetes.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not plan to move away during the study period.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 1-2, 7-8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1-2, 7-8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hemoglobin A1c
Secondary study objectives
Blood pressure
Body Mass Index
Diabetes distress
+6 moreOther study objectives
Cost-effectiveness (HbA1c -1%)
Cost-effectiveness (HbA1c <7%)
Dose delivered
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Intervention arm participants will receive produce prescription services for a defined period of time (4-6months)
Group II: Control ArmActive Control1 Intervention
Control arm participants will not receive produce prescriptions but will receive standard of care services for diabetes management
Find a Location
Who is running the clinical trial?
University of Colorado, DenverOTHER
1,786 Previous Clinical Trials
2,779,418 Total Patients Enrolled
University of California, San FranciscoOTHER
2,550 Previous Clinical Trials
15,269,891 Total Patients Enrolled
Lawndale Christian Health CenterUNKNOWN
1 Previous Clinical Trials
150 Total Patients Enrolled
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