Fresh Takes!: Fresh Food Boxes for Diabetes and Food Insecurity

This study, called "Fresh Takes!", is looking at how receiving fresh produce boxes, along with nutrition education and support, can help people with diabetes or prediabetes (higher than normal blood sugar levels, but not yet diabetes) who also experience food insecurity (not having reliable access to enough affordable, nutritious food). The program lasts for six months. Researchers want to see if this program can improve blood sugar levels (measured by HbA1c, a test that shows your average blood sugar over the past 2-3 months) and reduce food insecurity. You may be able to join if you are between 18 and 75 years old, are a patient of Montefiore Bronx Health Collective, have experienced food insecurity in the past year, and have either diabetes or prediabetes. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 400 participants.
What's involved
Participants in the Fresh Takes! program will receive fresh food boxes twice a month, attend group nutrition education sessions during food pickup, and get individualized support from a dietitian over a six-month period.
Compensation
Not stated in the trial record.
Follow-up
Your HbA1c levels will be measured up to 12 months after the program ends, for a total of up to 18 months. Food security will be measured at the start, at 3 months, and at 6 months (program completion).

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NCT06019624

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

Recruiting
NAAges 18–75InterventionalPrevention
Montefiore Medical Center
~400 participants
Updated 2025-09-26 on ClinicalTrials.gov
What's tested:Fresh Takes!

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in HbA1c levels
Measured over From baseline up to 12 months after program completion, up to 18 months total
+1 more outcome measured
Diabetes
PreDiabetes
Food Insecurity
1 sites across 1 states
New York1
  • Barbara Hackley, PhD · STUDY_DIRECTOR · Montefiore Medical Center
  • Rubayat Qadeer, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

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Eligibility criteria

Inclusion

18-75 years of age
Be a patient of BHC
Experienced food insecurity in the previous year
  • Change in HbA1c levelsFrom 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 SecurityAt baseline (intake visit), 3 months, and at 6 months (program completion)

    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.