Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes for Type 2 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Type 2 DiabetesDiabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether monthly food vouchers or monthly mailed food boxes are better for glycemic control in low income, food insecure, African Americans with Type 2 Diabetes. The trial will also test whether providing diabetes education in combination with food supplementation leads to improved clinical outcomes compared to education alone.

Eligible Conditions
  • Type 2 Diabetes

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 12-months post randomization

12-months post randomization
Blood Pressure
Glycemic control (HbA1c)
LDL-Cholesterol
Quality of Life as measured by the SF-12

Trial Safety

Trial Design

4 Treatment Groups

Group 1- Diabetes Education Only
1 of 4
Group 3 - Diabetes Education Plus Monthly Stock Boxes
1 of 4
Group 2 - Diabetes Education Plus Monthly Food Vouchers
1 of 4
Group 4 -- Diabetes Education Plus Combination of Monthly Food
1 of 4

Active Control

Experimental Treatment

300 Total Participants · 4 Treatment Groups

Primary Treatment: Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes · No Placebo Group · N/A

Group 3 - Diabetes Education Plus Monthly Stock Boxes
Behavioral
Experimental Group · 1 Intervention: Diabetes Education Plus Monthly Stock Boxes · Intervention Types: Behavioral
Group 2 - Diabetes Education Plus Monthly Food Vouchers
Behavioral
Experimental Group · 1 Intervention: Diabetes Education Plus Monthly Food Vouchers · Intervention Types: Behavioral
Group 4 -- Diabetes Education Plus Combination of Monthly Food
Behavioral
Experimental Group · 1 Intervention: Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes · Intervention Types: Behavioral
Group 1- Diabetes Education Only
Behavioral
ActiveComparator Group · 1 Intervention: Diabetes Education Only · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12-months post randomization

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
566 Previous Clinical Trials
1,153,868 Total Patients Enrolled
Leonard E Egede, MDPrincipal InvestigatorMedical College of Wisconsin
Rebekah J Walker, PhDPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
150 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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