Clinical trial NCT06019624: Fresh Takes!: An Evaluation of the Impact of Receiving Fresh Food Boxes
Official title: Fresh Takes!: An Evaluation of the Impact of Receiving Fresh Food Boxes on Dietary Intake, Food Insecurity, and Diabetic Control for Individuals With Diabetes or Prediabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
PreDiabetes
Food Insecurity
Keywords: Diabetes
PreDiabetes
Food Insecurity
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2023-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 18-75 years of age
* Be a patient of BHC
* Experienced food insecurity in the previous year

Identified as:

1. 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
2. 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.

Primary outcomes:
measure: Change in HbA1c levels
timeFrame: From baseline up to 12 months after program completion, up to 18 months total
measure: Change in Food Security
timeFrame: At baseline (intake visit), 3 months, and at 6 months (program completion)
Secondary outcomes:
measure: Change in Fruit and Vegetable Intake
timeFrame: At baseline (intake visit), 3 months, and at 6 months (program completion)
measure: Change in Fruit and Vegetable Consumption
timeFrame: At baseline (intake visit), 3 months, and at 6 months (program completion)
measure: Number of Diabetes-related Primary Health Care visits
timeFrame: From baseline up to 12 months after program completion, up to 18 months total
measure: Change in Emergency Room Utilization
timeFrame: From baseline up to 12 months after program completion, up to 18 months total
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Bronx Health Collective
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Barbara Hackley, PhD
role: STUDY_DIRECTOR
affiliation: Montefiore Medical Center
name: Rubayat Qadeer, MD
role: PRINCIPAL_INVESTIGATOR
References: