Fresh Takes!: An Evaluation of the Impact of Receiving Fresh Food Boxes
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Details and patient eligibility
About
Fresh Takes! is a targeted food distribution and nutrition education program offered by Montefiore Bronx Health Collective, a Federally Qualified Health Center located in the South Bronx. The goal of Fresh Takes! is to help reduce food insecurity and prevent progressions to overt diabetes in patients with prediabetes and to help patients with overt diabetes achieve better diabetic control. To that end, participants receive bimonthly fresh food boxes and nutritional support and education over the course of a six-month program.
Full description
Diabetes affects approximately one in 10 individuals in the United States and is associated with cardiovascular disease, nerve and retinal damage, and kidney disease. In 2019, it was reported to be the 7th leading cause of death nationally. Unfortunately, diabetes disproportionally affects people of color, those of heavier weight, and those with lower incomes. All of these characteristics are common in residents of the communities served by Montefiore Bronx Health Collective (BHC). Enrolling patients in care at BHC with prediabetes or overt diabetes into Fresh Takes! has the potential to improve short term outcomes and reduce the risk of developing diabetes-associated comorbidities for a highly vulnerable population. The 6-month program has three major components: 1) receipt of a fresh food box twice each month, 2) group nutrition education provided at the time of bimonthly food pickup, and 3) individualized support by a dietician. One of the unique aspects of Fresh Takes! is the provision of a fresh food box to participants. Healthier dietary patterns have been found to be associated with significantly lower risk of developing diabetes and better glycemic control among individuals with diabetes. Yet, little research to date has been conducted on the impact of providing fresh fruits and vegetables on diabetic control for individuals with diabetes or prediabetes.
As an exploratory assessment, following a protocol amendment submitted and approved by the IRB, to determine whether extra education and support is helpful for patients in using all of the contents of the food box, a sub-study was embedded into the existing study by providing an information intervention. As part of this sub-study, all cohort participants will receive individual assessment, education, and a food demonstration and recipe using the contents of the box. Each cohort participant will then be randomized to receive one of the following interventions: 1. Instructions to cut and store vegetables or 2. Instructions to cutting & storing vegetables+ additional recipes customized to the contents of the food box. A block randomization approach to randomize participants to receive the intervention will be used. To avoid contamination, the package will be placed within food delivery packages. This sub-substudy will not impact any of the Outcome Measures in this study.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
- 18-75 years of age
- Be a patient of BHC
- Experienced food insecurity in the previous year
Identified as:
- having diabetes based on an ICD diagnosis code in the Electronic Medical Record (EMR) or having a less than ideal HbA1c level, defined as >6.4% within the preceding 12 months OR
- having prediabetes based on an ICD diagnosis code in the EMR or by having a HbA1c level between 5.7% - 6.4% in the preceding 12 months.
Trial design
Primary purpose
Allocation
Interventional model
Masking
400 participants in 4 patient groups
Trial contacts and locations
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Central trial contact
Barbara Hackley, PhD; Fadhylla Saballos, MPH
Data sourced from clinicaltrials.gov
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