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

Primary Purpose

Diabetes, PreDiabetes, Food Insecurity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fresh Takes!
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Diabetes, PreDiabetes, Food Insecurity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-75 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.

Sites / Locations

  • Montefiore Bronx Health CollectiveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Cohort 1 Receipt of Food Box

Cohort 2 Receipt of Food Box

Cohort 3 Receipt of Food Box

Cohort 4 Receipt of Food Box

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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. Elevated HbA1c levels are a significant risk factor in many disease conditions. Better glycemic control leads to more favorable outcomes.
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.

Secondary Outcome Measures

Change in Fruit and Vegetable Intake
Change in fruit and vegetable intake form pre- to post-intervention as measured by Fruit and Vegetable module of the Dietary Screener Questionnaire (DSQ-FV). The DSQ-FV consists of 10 questions that queries participants regarding their intake of fruits and vegetables. Responses to the questions are converted to an estimated daily average per participant. Higher fruit and vegetable intake is associated with better glycemic control and better overall health.
Number of diabetes-related primary health care visits
The number of diabetes-related primary health care visits will be recorded to determine if individuals enrolled in Fresh Takes! have fewer excess visits related to diabetes pre- as compared to post-intervention. Diabetes-related visits will be determined from the electronic medical record (EMR) Diabetes-related visits will be pulled from the Electronic Medical Record (EMR) and defined as visits that have an associated ICD code indicating care for diabetes in the 6 months prior to enrollment. Excess care for this study is defined as having more than one visit for diabetes care in a 6-month period.
Change in Emergency Room Utilization
Change in emergency room (ER) utilization will be assessed by the number of emergency room visits to determine if individuals enrolled in Fresh Takes! have fewer emergency room visits related to diabetes pre- as compared to post-intervention. Changes in ER use will be analyzed based on surveys and number of ER visits pulled from the EMR for the 6 months prior to enrollment in Fresh Takes! compared to the number of ER visits for participants in the 6 months following program completion.

Full Information

First Posted
August 25, 2023
Last Updated
October 3, 2023
Sponsor
Montefiore Medical Center
Collaborators
United States Department of Agriculture (USDA)
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1. Study Identification

Unique Protocol Identification Number
NCT06019624
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
United States Department of Agriculture (USDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, PreDiabetes, Food Insecurity
Keywords
Diabetes, PreDiabetes, Food Insecurity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 Receipt of Food Box
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cohort 2 Receipt of Food Box
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cohort 3 Receipt of Food Box
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cohort 4 Receipt of Food Box
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fresh Takes!
Intervention Description
Receipt of a fresh produce box, nutritional education and support in a 6 month program
Primary Outcome Measure Information:
Title
Change in HbA1c levels
Description
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. Elevated HbA1c levels are a significant risk factor in many disease conditions. Better glycemic control leads to more favorable outcomes.
Time Frame
From baseline up to 12 months after program completion, up to 18 months total
Title
Change in Food Security
Description
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.
Time Frame
From baseline up to 12 months after program completion, up to 18 months total
Secondary Outcome Measure Information:
Title
Change in Fruit and Vegetable Intake
Description
Change in fruit and vegetable intake form pre- to post-intervention as measured by Fruit and Vegetable module of the Dietary Screener Questionnaire (DSQ-FV). The DSQ-FV consists of 10 questions that queries participants regarding their intake of fruits and vegetables. Responses to the questions are converted to an estimated daily average per participant. Higher fruit and vegetable intake is associated with better glycemic control and better overall health.
Time Frame
6 months
Title
Number of diabetes-related primary health care visits
Description
The number of diabetes-related primary health care visits will be recorded to determine if individuals enrolled in Fresh Takes! have fewer excess visits related to diabetes pre- as compared to post-intervention. Diabetes-related visits will be determined from the electronic medical record (EMR) Diabetes-related visits will be pulled from the Electronic Medical Record (EMR) and defined as visits that have an associated ICD code indicating care for diabetes in the 6 months prior to enrollment. Excess care for this study is defined as having more than one visit for diabetes care in a 6-month period.
Time Frame
Up to 12 months after program completion, up to 18 months total
Title
Change in Emergency Room Utilization
Description
Change in emergency room (ER) utilization will be assessed by the number of emergency room visits to determine if individuals enrolled in Fresh Takes! have fewer emergency room visits related to diabetes pre- as compared to post-intervention. Changes in ER use will be analyzed based on surveys and number of ER visits pulled from the EMR for the 6 months prior to enrollment in Fresh Takes! compared to the number of ER visits for participants in the 6 months following program completion.
Time Frame
From baseline up to 12 months after program completion, up to 18 months total

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-75 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Hackley, PhD
Phone
2032603599
Email
bhackley@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Fadhylla Saballos, MPH
Phone
7189910605
Email
fsaballo@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Hackley, PhD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rubayat Qadeer, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Bronx Health Collective
City
Bronx
State/Province
New York
ZIP/Postal Code
10459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Hackley, PHD
Phone
203-260-3599
Email
bhackley@montefiore.org
First Name & Middle Initial & Last Name & Degree
Fadhylla fsaballo@montefiore.org, MPH
Phone
7189910605
Email
fsaballo@montefiore.org
First Name & Middle Initial & Last Name & Degree
Fadhylla Saballos, MPH
First Name & Middle Initial & Last Name & Degree
Rubayat Qadeer, MD
First Name & Middle Initial & Last Name & Degree
Barbara Hackley, PHD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data to be shared with other researchers

Learn more about this trial

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

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