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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06019624
Study type	Interventional
Source	Montefiore Medical Center
Contact	Barbara Hackley, PhD
Phone	2032603599
Email	bhackley@montefiore.org
Status	Recruiting
Phase	N/A
Start date	September 13, 2023
Completion date	June 2027

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.