NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: State University of New York at Buffalo
Conditions: Type 2 Diabetes
Interventions: Diabetes Education Plus Monthly Food Vouchers, Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes, Diabetes Education Only, Diabetes Education Plus Monthly Stock Boxes
Countries: United States
The objective of this protocol is to answer the questions: 1) Within food supplementation options, are mailed stock boxes superior to food vouchers in terms of achieving glycemic control? 2) Is the combination of mailed stock boxes and food vouchers superior to either food supplementation option alone? 3) Does providing diabetes education in combination with food supplementation lead to improved clinical outcomes compared to education alone? To address this gap in the literature, we propose a randomized controlled trial to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with Type 2 Diabetes (T2DM) using a 2x2 factorial design.
Sex: ALL
Age: 21 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: 1) age \>=21 years; 2) self-report as African American/non-Hispanic Black; 3) screen positive for food insecurity over past 12-months using screening questionnaire; 4) clinical diagnosis of type 2 diabetes and HbA1c \>=8% at the screening visit; 5) income \<=133% of federal poverty level based on household income and size of household or Medicaid eligible; 6) able to communicate in English. Exclusion Criteria: 1) Mental confusion on interview suggesting significant dementia; 2) Participation in other diabetes clinical trials; 3) Alcohol or drug abuse/dependency; 4) Active psychosis or acute mental disorder; and 5) Life expectancy \<12 months.
- Buffalo, New York, United States