DiabetesNCT06019624
Fresh Takes!: An Evaluation of the Impact of Receiving Fresh Food Boxes
A study testing Fresh Takes! in people with Diabetes and PreDiabetes, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, PreDiabetes, Food Insecurity
- What is being tested?
- Fresh Takes!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2023to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Bronx Health Collective
The Bronx, New York, 10459
About this study
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
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.
Read the 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 Institutional Review Board (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.
- Conditions
- Diabetes, PreDiabetes, Food Insecurity
- Being tested
- Fresh Takes!
- Keywords
- Diabetes, PreDiabetes, Food Insecurity
- Medical subject headings
- Diabetes Mellitus, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Takes!Behavioural
Receipt of a fresh produce box, nutritional education and support in a 6 month program
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Receipt of Food Box | Active comparator | 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. Receives: Behavioral: Fresh Takes! |
| Cohort 2 Receipt of Food Box | Active comparator | 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. Receives: Behavioral: Fresh Takes! |
| Cohort 3 Receipt of Food Box | Active comparator | 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. Receives: Behavioral: Fresh Takes! |
| Cohort 4 Receipt of Food Box | Active comparator | 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. Receives: Behavioral: Fresh Takes! |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 United States Department of Agriculture (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.
Measured: At baseline (intake visit), 3 months, and at 6 months (program completion)
Secondary outcomes (4)
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. Change from baseline results for each cohort will be summarized using basic descriptive statistics.
Measured: At baseline (intake visit), 3 months, and at 6 months (program completion)
Change in Fruit and Vegetable Consumption
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.
Measured: At baseline (intake visit), 3 months, and at 6 months (program completion)
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 International Classification of Diseases (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.
Measured: From baseline up to 12 months after program completion, up to 18 months total
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. Change from baseline results for each cohort will be summarized using basic descriptive statistics.
Measured: From baseline up to 12 months after program completion, up to 18 months total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start13 Sep 2023
- Primary completion22 Jul 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Gretchen Swanson Center for Nutrition
- Responsible party
- Sponsor
- Investigators
- Barbara Hackley, PhD, Study director, Montefiore Medical CenterRubayat Qadeer, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019624
- Sponsor's protocol ID
- 2023-14791
- Other IDs
- 2022-70424-38499, 2023
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data to be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06019624
- Acronym / sponsor ID
- 2023-14791
- Conditions
- Diabetes, PreDiabetes, Food Insecurity
- Keywords
- Diabetes, PreDiabetes, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Gretchen Swanson Center for Nutrition
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Institutional Review Board (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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Receipt of Food Box | Active comparator | Behavioral: Fresh Takes!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. |
| Cohort 2 Receipt of Food Box | Active comparator | Behavioral: Fresh Takes!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. |
| Cohort 3 Receipt of Food Box | Active comparator | Behavioral: Fresh Takes!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. |
| Cohort 4 Receipt of Food Box | Active comparator | Behavioral: Fresh Takes!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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-75 years of age
- Be a patient of BHC
- Experienced food insecurity in the previous year
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh Takes!Receipt of a fresh produce box, nutritional education and support in a 6 month program | Behavioural | Cohort 1 Receipt of Food Box, Cohort 2 Receipt of Food Box, Cohort 3 Receipt of Food Box, Cohort 4 Receipt of Food Box |
Primary outcome
Change in HbA1c levels
Time frame: From baseline up to 12 months after program completion, up to 18 months total
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.
Change in Food Security
Time frame: At baseline (intake visit), 3 months, and at 6 months (program completion)
Change in food security from preintervention to postintervention as measured by the United States Department of Agriculture (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.
4 secondary outcomes
Change in Fruit and Vegetable Intake
Time frame: At baseline (intake visit), 3 months, and at 6 months (program completion)
Change in Fruit and Vegetable Consumption
Time frame: At baseline (intake visit), 3 months, and at 6 months (program completion)
Number of Diabetes-related Primary Health Care visits
Time frame: From baseline up to 12 months after program completion, up to 18 months total
Change in Emergency Room Utilization
Time frame: From baseline up to 12 months after program completion, up to 18 months total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. No data to be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Hackley, PhD study director
Montefiore Medical Center
Rubayat Qadeer, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh Takes! in people with Diabetes and PreDiabetes, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c levels (time frame: From baseline up to 12 months after program completion, up to 18 months total). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.