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.
Brief Title
Fresh Takes!: An Evaluation of the Impact of Receiving Fresh Food Boxes
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.
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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
2032603599
Central Contact Email
bhackley@montefiore.org
Central Contact Role
Contact
Central Contact Phone
7189910605
Central Contact Email
fsaballo@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Diabetes
PreDiabetes
Food Insecurity
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Diabetes
PreDiabetes
Food Insecurity
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT06019624
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2023-14791
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome 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. 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.
Outcome Measure
Change in HbA1c levels
Outcome Time Frame
From baseline up to 12 months after program completion, up to 18 months total
Outcome 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. Group results within each cohort will be summarized.
Outcome Measure
Change in Food Security
Outcome Time Frame
At baseline (intake visit), 3 months, and at 6 months (program completion)
Secondary Outcomes
Outcome 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. Change from baseline results for each cohort will be summarized using basic descriptive statistics.
Outcome Time Frame
At baseline (intake visit), 3 months, and at 6 months (program completion)
Outcome Measure
Change in Fruit and Vegetable Intake
Outcome Description
Change in fruit and vegetable consumption will be objectively assessed using a Veggie Meter®. The Veggie Meter is a validated noninvasive device that uses pressure-mediated reflection spectroscopy (RS) to assess the level of skin carotenoids and provides a comparative output of an individual's skin carotenoid score corresponding to data from the general population. The primary goal is to determine the trajectory of carotenoid responsivity to changes in dietary intake. To avoid measurement error, the multi-measurement mode using an average of 3 measurements of carotenoid score as an in-built part of the device will be used. Participants will insert and retract their finger 3 times and an average score will be determined from the 3 values. Change from baseline results for each cohort will be summarized using basic descriptive statistics. Habitual consumption of fruits and vegetables are correlated with increased Veggie Meter skin carotenoid scores.
Outcome Time Frame
At baseline (intake visit), 3 months, and at 6 months (program completion)
Outcome Measure
Change in Fruit and Vegetable Consumption
Outcome 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. Group results for each cohort will be summarized.
Outcome Time Frame
From baseline up to 12 months after program completion, up to 18 months total
Outcome Measure
Number of Diabetes-related Primary Health Care visits
Outcome 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. Change from baseline results for each cohort will be summarized using basic descriptive statistics.
Outcome Time Frame
From baseline up to 12 months after program completion, up to 18 months total
Outcome Measure
Change in Emergency Room Utilization
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rubayat Qadeer
Investigator Email
rqadeer@montefiore.org