Fresh Takes!: An Evaluation of the Impact of Receiving Fresh Food Boxes
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Sep 2023
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2023
CompletedFirst Posted
Study publicly available on registry
August 31, 2023
CompletedStudy Start
First participant enrolled
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
September 26, 2025
September 1, 2025
3.7 years
August 25, 2023
September 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in HbA1c levels
Change in HbA1C levels will be evaluated from preintervention to postintervention. Participants' baseline HbA1c values will be abstracted from medical records. The HbA1c value obtained during clinical care closest to the time of enrollment will serve as the baseline value. The HbA1c reading obtained during clinical care closest to the end date of the program will be used as the follow up measure. For participants with prediabetes, blood glucose levels will be measured to see whether HbA1c values have normalized (i.e., HbA1c \< 5.7%). Participants with diabetes will be assessed as to whether they have achieved better diabetic control (i.e., reduction of 0.5% from their baseline HbA1c level). Change from baseline group results for prediabetes and diabetes participants within each cohort will be summarized using basic descriptive statistics. Elevated HbA1c levels are a significant risk factor in many disease conditions. Better glycemic control leads to more favorable outcomes.
From baseline up to 12 months after program completion, up to 18 months total
Change in Food Security
Change in food security from preintervention to postintervention as measured by the USDA Six-item Short Form of the Food Security Survey. Participant responses are coded as described on the short form and the sum of affirmative responses to the six questions in the module represents the raw score on the scale with a possible scoring range of 0-6 with higher scores being indicative of greater food insecurity. Specifically, an overall score from 0-1 represents high food security; an overall score from 2-4 represents low food security; and an overall score from 5-6 represents very low food security. Group results within each cohort will be summarized.
At baseline (intake visit), 3 months, and at 6 months (program completion)
Secondary Outcomes (4)
Change in Fruit and Vegetable Intake
At baseline (intake visit), 3 months, and at 6 months (program completion)
Change in Fruit and Vegetable Consumption
At baseline (intake visit), 3 months, and at 6 months (program completion)
Number of Diabetes-related Primary Health Care visits
From baseline up to 12 months after program completion, up to 18 months total
Change in Emergency Room Utilization
From baseline up to 12 months after program completion, up to 18 months total
Study Arms (4)
Cohort 1 Receipt of Food Box
ACTIVE COMPARATORUp 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.
Cohort 2 Receipt of Food Box
ACTIVE COMPARATORUp 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.
Cohort 3 Receipt of Food Box
ACTIVE COMPARATORUp 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.
Cohort 4 Receipt of Food Box
ACTIVE COMPARATORUp 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
Receipt of a fresh produce box, nutritional education and support in a 6 month program
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Bronx Health Collective
The Bronx, New York, 10459, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Barbara Hackley, PhD
Montefiore Medical Center
- PRINCIPAL INVESTIGATOR
Rubayat Qadeer, MD
Montefiore Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2023
First Posted
August 31, 2023
Study Start
September 13, 2023
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
September 26, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
No data to be shared with other researchers