Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes for Type 2 Diabetes
Phase-Based Progress Estimates
Effectiveness
Safety
Type 2 DiabetesDiabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes - Behavioral
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
Effectiveness Progress
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
Safety Progress
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: BehavioralGroup 2 - Diabetes Education Plus Monthly Food Vouchers
Behavioral
Experimental Group · 1 Intervention: Diabetes Education Plus Monthly Food Vouchers · Intervention Types: BehavioralGroup 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: BehavioralGroup 1- Diabetes Education Only
Behavioral
ActiveComparator Group · 1 Intervention: Diabetes Education Only · Intervention Types: BehavioralTrial 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
Mark “Yes” if the following statements are true for you:References
- Walker, Rebekah J., Rebecca G. Knapp, Clara E. Dismuke-Greer, Renee E. Walker, Mukoso N. Ozieh, and Leonard E. Egede. 2020. “Lowering the Impact of Food Insecurity in African American Adults with Type 2 Diabetes Mellitus (LIFT-DM) – Study Protocol for a Randomized Controlled Trial”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2020.106206.
- Egede, Leonard E 2019. "Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (LIFT-DM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04181424.
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