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

Study Details

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.

Conditions

Diabetes

PreDiabetes

Food Insecurity

Study ID

NCT06019624

Start date

Sep 13, 2023

Status verified date

Sep, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: Cohort 2 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.

active comparator: Cohort 3 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.

active comparator: Cohort 4 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.

Interventions

Fresh Takes!

Receipt of a fresh produce box, nutritional education and support in a 6 month program

Primary outcome measure

Change in HbA1c levels [ Time Frame: From baseline up to 12 months after program completion, up to 18 months total ]
Change in Food Security [ Time Frame: At baseline (intake visit), 3 months, and at 6 months (program completion) ]