Fresh Takes!: An Evaluation of the Impact of Receiving Fresh Food Boxes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-13

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes PreDiabetes Food Insecurity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cohort 1 Receipt of Food Box

Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.

Group Type ACTIVE_COMPARATOR